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In This Article
   G. Achari Prize ...
   G. ACHARI PRIZE ...
   G. ACHARI PRIZE ...
   G. ACHARI PRIZE ...
   G. ACHARI PRIZE ...
   G. ACHARI PRIZE ...
   G. ACHARI PRIZE ...
   G. ACHARI PRIZE ...
   G. ACHARI PRIZE ...
   G. ACHARI PRIZE ...
   G. ACHARI PRIZE ...
   G. ACHARI PRIZE ...
   G. ACHARI PRIZE ...
   G. ACHARI PRIZE ...
   G. ACHARI PRIZE ...
   G. ACHARI PRIZE ...
   G. ACHARI PRIZE ...
  U.K. Sheth Prize
   U.K. SHETH PRIZE...
   U.K. SHETH PRIZE...
   U.K. SHETH PRIZE...
   U.K. SHETH PRIZE...
   U.K. SHETH PRIZE...
   U.K. SHETH PRIZE...
   U.K. SHETH PRIZE...
   U.K. SHETH PRIZE...
   U.K. SHETH PRIZE...
   U.K. SHETH PRIZE...
   U.K. SHETH PRIZE...
  Manjeet Singh Prize
   MANJEET SINGH PR...
   MANJEET SINGH PR...
   MANJEET SINGH PR...
   MANJEET SINGH PR...
   MANJEET SINGH PR...
   OD GULATI PRIZE ...
  OD Gulati Prize
   OD GULATI PRIZE ...
   OD GULATI PRIZE ...
   OD GULATI PRIZE ...
   OD GULATI PRIZE ...
   OD GULATI PRIZE ...
   OD GULATI PRIZE ...
   OD GULATI PRIZE ...
  GUFIC Prize
   GUFIC PRIZE R...
   GUFIC PRIZE R...
   GUFIC PRIZE R...
   GUFIC PRIZE R...
   GUFIC PRIZE R...
   GUFIC PRIZE R...
   GUFIC PRIZE R...
   GUFIC PRIZE R...
   GUFIC PRIZE R...
   GUFIC PRIZE R...
   GUFIC PRIZE R...
   GUFIC PRIZE R...
   GUFIC PRIZE R...
   GUFIC PRIZE R...
  PC Dandiya Prize
   PC DANDIYA PRIZE...
   PC DANDIYA PRIZE...
   PC DANDIYA PRIZE...
   PC DANDIYA PRIZE...
   PC DANDIYA PRIZE...
   PC DANDIYA PRIZE...
   PC DANDIYA PRIZE...
   PC DANDIYA PRIZE...
   PC DANDIYA PRIZE...
  Oral
   AIN (ANTI-INFLAM...
   AIN – 1: E...
   AIN – 2: A...
   AIN – 3: C...
   AIN – 4: E...
   AIN – 5: P...
   AIN – 6: A...
   AIN – 7: E...
   ANS – 1: I...
   AUTO (AUTOCOID P...
   AUTO – 1: ...
   AUTO – 2: ...
   AUTO – 3: ...
   IMP (INFLAMMATOR...
   IMP – 1: F...
   IMP – 2: A...
   IMP-3: Cholinerg...
   BP (BEHAVIOURAL ...
   BP – 1: Ev...
   BP – 2: Ev...
   BP – 3: MC...
   BP – 4: Ho...
   BP – 5: To...
   BP – 6: Sc...
   BP – 7: Ef...
   BP – 8:
   CEL (CELLULAR/MO...
   CEL – 1: A...
   CEL – 2: K...
   CEL – 3: E...
   CEL – 4: C...
   IND (INDEGENOUS ...
   IND – 1: P...
   IND – 2: H...
   IND – 3: A...
   IND – 4: T...
   IND – 5: <...
   IND – 6: P...
   IND – 7: A...
   IND – 8: A...
   IND – 9: A...
   IND – 10: ...
   CPRA (CLINICAL P...
   CPRA – 1: ...
   CPRA – 2: ...
   CPRA – 3: ...
   CPRA – 4: ...
   CPRA – 5: ...
   CPRA – 6: ...
   CPRA – 7: ...
   CPRA – 8: ...
   CPRA – 9: ...
  CHM (CHEMOTHERAPY)
   CHM – 1: C...
   CHM – 2: P...
   CHM – 3: D...
   CHM – 4: E...
   CHM – 5: S...
   CHM – 6: C...
   CHM – 7: P...
   CHM – 8: T...
   CHM – 9: <...
   CHM – 10: ...
   PK (PHARMACOKINE...
   PK – 1: Va...
   PK – 2: Co...
   PK – 3: Ph...
   NEU (NEUROPHARMA...
   NEU – 1: A...
   NEU – 2: C...
   NEU- 3: Study to...
   NEU- 4: A Compar...
   NEU- 5: Drug Ind...
   NEU – 6: E...
   NEU – 7: A...
   NEU – 8: T...
   NEU- 9: Perillyl...
   NEU – 10: ...
   NEU – 11: ...
   NEU – 12: ...
   NEU – 13: ...
   NEU – 14: ...
   NEU – 15: ...
   NEU – 16: ...
   NEU – 17: ...
   NEU – 18: ...
   NEU- 19: Umbelli...
   NEU – 20: ...
   NEU – 21: ...
   NEU- 22: Niflumi...
   NEU – 23: ...
   NEU – 24: ...
   NEU – 25: ...
   NEU – 26: ...
   NEU – 27: ...
   NEU – 28: ...
   NEU – 29: ...
   NEU – 30: ...
   NEU- 31: Study o...
   NEU – 32: ...
   NEU – 33: ...
   NEU – 34: ...
   NEU – 35: ...
   NEU – 36: ...
  TOX (TOXICOLOGY)
   TOX – 1: C...
   TOX – 2: S...
   TOX – 3: P...
   TOX – 4: H...
   TOX – 5: P...
   TOX – 6: P...
   TOX – 7: H...
   TOX – 8: S...
   TOX – 9: R...
   TOX – 10: ...
   TOX – 11: ...
   TOX – 12: ...
   TOX – 13: ...
   GIT (GASTROINTES...
   GIT – 1: H...
   GIT – 2: A...
   GIT – 3: B...
   ENDO (ENDOCRINE ...
   ENDO – 1: ...
   ENDO – 2: ...
   ENDO – 3: ...
   ENDO – 4: ...
   ENDO – 5: ...
   ENDO – 6: ...
   ENDO – 7: ...
   ENDO – 8: ...
   ENDO – 9: ...
   ENDO – 10:...
   ENDO – 11:...
   ENDO – 12:...
   ENDO – 13:...
   ENDO – 14:...
   ENDO – 15:...
   ENDO – 16:...
   ENDO – 17:...
   CVS (CARDIOVASCU...
   CVS – 1: A...
   CVS – 2: A...
   CVS – 3: C...
   CVS – 4: E...
   CVS – 5: S...
   CVS – 6: E...
   CVS – 7: C...
   CVS – 8: C...
   CVS – 9: T...
   CVS – 10: ...
   CVS – 11: ...
   CVS – 12: ...
   CVS – 13: ...
   CVS –14: D...
   CVS – 15: ...
   RSP (RESPIRATORY...
   RSP – 1: I...
   RSP – 2: R...
   CP (CLINICAL PHA...
   CP – 1: A ...
   CP – 2: Dr...
   CP – 3: Ef...
   CP – 4: Dr...
   CP – 5: An...
   CP – 6: A ...
   CP – 7: Th...
   CP – 8: Co...
   CP – 9: An...
   CP – 10: S...
   CP – 11: V...
   CP – 12: C...
   CP – 13: C...
   CP – 14: S...
   CP – 15: P...
   CP – 16: C...
   CP – 17: A...
   CP – 18: C...
   CP – 19: A...
   CP – 20: A...
   CP – 21: A...
   CP – 22: S...
   CP – 23: A...
   CP – 24: R...
   CP – 25: C...
   CP – 26: T...
   CP – 27: A...
   CP – 28: C...
   RDU (RATIONAL DR...
   RDU – 1: S...
   RDU – 2: P...
   RDU – 3: A...
   RDU – 4: D...
   RDU – 5: A...
   RDU – 6 : ...
   RDU – 7: S...
   RDU – 8: I...
   RDU – 9: A...
   RDU – 10: ...
   RDU – 11: ...
   RDU – 12: ...
   RDU – 13: ...
   RDU – 14: ...
   RDU – 15: ...
   RDU – 16: ...
   RDU – 17: ...
   RDU – 18: ...
   RDU – 19: ...
   RDU – 20: ...
   RDU – 21: ...
   RDU – 22: ...
   RDU – 23: ...
   RDU – 24: ...
   RDU – 25: ...
   Category: Miscel...
   RDU – 26: ...
   RDU – 27: ...
   RDU – 28: ...
   RDU – 29: ...
   RDU – 30: ...
   RDU – 31: ...
   RDU – 32: ...
   RDU – 33: ...
   RDU – 34: ...
   RDU – 35: ...
   RDU – 36: ...
   RDU – 37: ...
   RDU – 38: ...
   RDU – 39: ...
   RDU – 40: ...
   RDU – 41: ...
   RDU – 42: ...
   RDU – 43: ...
  MISC (MISCELLANEOUS)
   MISC – 1: ...
   MISC – 2: ...
   MISC – 3: ...
   MISC – 4: ...
   MISC – 5: ...
   MISC – 6: ...
   MISC – 7: ...
   MISC – 8: ...
   MISC – 9: ...
   MISC – 10:...
   MISC – 11:...
   MISC – 12:...
   MISC – 13:...
   MISC – 14:...
   MISC-15: Assessm...
   MISC – 16:...
   MISC – 17:...
   MISC-18: A Syste...
   MISC – 19:...
   MISC-20: Pattern...
   MISC – 21:...
   MISC – 22:...
   MISC – 23:...
   MISC – 24:...
   MISC – 25:...
   MISC-26: An Obse...
   MISC – 27:...
   MISC – 28:...
   MISC – 29:...
   MISC – 30:...
   MISC – 31:...
   MISC – 32:...
   MISC – 33:...
   MISC – 34:...
   MISC – 35:...
   MISC – 36:...
   MISC – 37:...
   MISC – 38:...
   MISC – 39:...
   MISC – 40:...
   MISC-41: Use of ...
   MISC – 42:...
   MISC-43: E-Rat v...
   AIN (ANTI-INFLAM...
   AIN – 1: E...
   AIN – 2: E...
   AIN – 3: A...
   AIN – 4: E...
   AIN – 5: A...
   AIN – 6: A...
   AIN – 7: E...
   AIN – 8: E...
   AIN – 9: P...
   AIN – 10: ...
   AIN – 11: ...
   AIN – 12: ...
   AIN – 13: ...
   AIN – 14: ...
   AIN – 15: ...
   AUTO (AUTOCOID P...
   AUTO – 1: ...
   AUTO – 2: ...
   AUTO – 3: ...
   AUTO – 4: ...
   IMP (INFLAMMATOR...
   IMP – 1: E...
   IMP- 2: In vi...
   IMP – 3: A...
   BP (BEHAVIOURAL ...
   BP – 1: Ev...
   BP – 2: Me...
   BP – 3: Ro...
   BP – 4: A ...
   BP – 5: A ...
   BP – 6: Ch...
   BP – 7: Be...
   BP – 8: Ag...
   BP – 9: In...
   BP – 10: A...
   BP – 11: A...
   BP – 12: A...
   BP – 13: L...
   BP – 14: R...
   BP – 15: E...
   BP – 16: A...
   BP – 17: T...
   BP – 18: T...
   BP – 19: <...
   BP – 20: W...
   CEL (CELLULAR/ M...
   CEL – 1: S...
   CEL – 2: I...
   CEL – 3: M...
   CEL – 4: A...
   CEL – 5: E...
   CEL – 6: P...
   CEL – 7: G...
   CEL – 8: S...
   CEL – 9: P...
   IND (INDEGENOUS ...
   IND – 1: H...
   IND – 2: T...
   IND – 3: V...
   IND – 4: R...
   IND – 5: E...
   IND – 6: <...
   IND – 7: <...
   IND – 8: N...
   IND – 9: P...
   IND – 10: ...
   IND – 11: ...
   IND – 12: ...
   IND – 13: ...
   IND – 14: ...
   IND – 15: ...
   IND – 16:...
   IND – 17: ...
   IND – 18: ...
   IND – 19: ...
   IND – 20: ...
   CPRA (CLINICAL P...
   CPRA – 1: ...
   CPRA – 2: ...
   CPRA – 3: ...
   CPRA – 4: ...
   CPRA – 5: ...
   CPRA – 6: ...
  CHM (CHEMOTHERAPY)
   CHM – 1: R...
   CHM – 2: C...
   CHM – 3: P...
   CHM – 4: A...
   CHM – 5: A...
   CHM – 6: A...
   CHM – 7: T...
   CHM – 8: E...
   CHM – 9: S...
   CHM – 10: ...
   PK (PHARMACOKINE...
   PK – 1: In...
   PK-2: The Effect...
   NEU (NEUROPHARMA...
   NEU – 1: S...
   NEU – 2: S...
   NEU – 3: A...
   NEU – 4: P...
   NEU – 5: A...
   NEU – 6: N...
   NEU – 7: R...
   NEU – 8: N...
   NEU – 9: N...
   NEU – 10: ...
   NEU – 11: ...
   NEU – 12: ...
   NEU – 13: ...
   NEU – 14: ...
   NEU – 15: ...
   NEU – 16: ...
   NEU – 17: ...
   NEU – 18: ...
   NEU – 19: ...
   NEU – 20: ...
   NEU – 21: ...
   NEU – 22: ...
   NEU – 23: ...
   NEU – 24: ...
   NEU – 25: ...
   NEU – 26: ...
   NEU – 27: ...
   NEU – 28: ...
   NEU – 29: ...
   NEU – 30: ...
   NEU – 31: ...
   NEU – 32: ...
   NEU – 33: ...
   NEU – 34: ...
   NEU – 35: ...
   NEU – 36: ...
   NEU – 37: ...
   NEU – 38: ...
   NEU – 39: ...
   NEU – 40: ...
   NEU – 41: ...
   NEU – 42: ...
   NEU – 43: ...
   NEU – 44: ...
   NEU – 45: ...
   NEU – 46: ...
   NEU – 47: ...
   NEU – 48: ...
   NEU – 49: ...
   NEU – 50: ...
   NEU – 51: ...
   NEU – 52: ...
   NEU – 53: ...
   NEU – 54: ...
   NEU – 55: ...
   NEU – 56: ...
   NEU – 57: ...
   NEU – 58: ...
   NEU – 59: ...
   NEU – 60: ...
   NEU – 61: ...
   NEU – 62: ...
   NEU – 63: ...
   NEU – 64: ...
   NEU – 65: ...
   NEU – 66: ...
   NEU – 67: ...
   NEU – 68: ...
   NEU – 69: ...
   NEU – 70: ...
   NEU – 71: ...
   NEU – 72: ...
   NEU – 73: ...
   NEU – 74: ...
   NEU – 75: ...
   NEU – 76: ...
   NEU – 77: ...
   NEU – 78: ...
   NEU – 79: ...
   NEU – 80: ...
  TOX (TOXICOLOGY)
   TOX – 1: E...
   TOX – 2: E...
   TOX – 3: N...
   TOX – 4: A...
   TOX – 5: P...
   TOX – 6: A...
   TOX – 7: P...
   TOX – 8: S...
   TOX – 9: E...
   TOX – 10: ...
   TOX – 11: ...
   TOX – 12: ...
   TOX – 13: ...
   TOX – 14: ...
   TOX – 15: ...
   GIT (GASTROINTES...
   GIT – 1: A...
   GIT – 2: U...
   GIT – 3: S...
   GIT – 4: P...
   GIT – 5: L...
   GIT – 6: S...
   GIT – 7: I...
   ENDO (ENDOCRINE ...
   ENDO – 1: ...
   ENDO – 2: ...
   ENDO – 3: ...
   ENDO – 4: ...
   ENDO – 5: ...
   ENDO – 6: ...
   ENDO – 7: ...
   ENDO – 8: ...
   ENDO – 9: ...
   ENDO – 10:...
   ENDO – 11:...
   ENDO – 12:...
   ENDO – 13:...
   ENDO – 14:...
   ENDO – 15:...
   ENDO – 16:...
   ENDO – 17:...
   ENDO – 18:...
   ENDO – 19:...
   ENDO – 20:...
   ENDO – 21:...
   CVS (CARDIOVASCU...
   CVS – 1: E...
   CVS – 2: A...
   CVS – 4: C...
   CVS – 5: A...
   CVS – 6: <...
   CVS – 7: D...
   CVS – 8: T...
   CVS – 9: C...
   CVS – 10: ...
   CVS – 11: ...
   CVS – 12: ...
   CVS -13: Effect ...
   CVS – 14: ...
   CVS – 15: ...
   CVS – 16: ...
   CVS – 17: ...
   RSP (RESPIRATORY...
   RSP – 1: A...
   RSP – 2: A...
   RSP – 3: C...
   RSP – 4: <...
   RSP – 5: P...
   RSP – 6: A...
   CP (CLINICAL PHA...
   CP – 1: Co...
   CP – 2: An...
   CP – 3: An...
   CP – 4: Ef...
   CP – 5: Ac...
   CP – 6: Ca...
   CP – 7: Pr...
   CP – 8: Po...
   CP – 9: Ef...
   CP – 10: P...
   CP – 11: A...
   CP – 12: A...
   CP – 13: A...
   CP – 14: C...
   CP – 15: A...
   CP – 16: C...
   CP – 17: T...
   CP – 18: C...
   CP – 19: E...
   CP – 20: C...
   CP – 21: U...
   CP – 22: O...
   RDU (RATIONAL DR...
   RDU – 1: A...
   RDU – 2: R...
   RDU – 3: C...
   RDU – 4: A...
   RDU – 5: P...
   RDU – 6: A...
   RDU – 7: D...
   RDU – 8: P...
   RDU – 9: T...
   RDU – 10: ...
   RDU – 11: ...
   RDU – 12: ...
  PRESENTATION: ORAL
   RDU – 13: ...
   RDU – 14: ...
   RDU – 15: ...
   RDU – 16: ...
   RDU – 17: ...
   RDU – 18: ...
   RDU – 19: ...
   RDU – 20: ...
   RDU – 21: ...
   RDU – 22: ...
   RDU – 23: ...
   RDU – 24: ...
   RDU – 25: ...
   RDU – 26: ...
   RDU – 27: ...
   RDU – 28: ...
   RDU – 29: ...
   RDU – 30: ...
   RDU – 31: ...
   RDU – 32: ...
   RDU – 33: ...
   RDU – 34: ...
   RDU – 35: ...
   RDU – 36: ...
   RDU – 37: ...
   RDU – 38: ...
   RDU – 39: ...
   RDU – 40: ...
   RDU – 41: ...
   RDU – 42: ...
   RDU – 43: ...
   RDU – 44: ...
   RDU – 45: ...
  MISC (MISCELLANEOUS)
   MISC – 1: ...
   MISC – 2: ...
   MISC – 3: ...
   MISC – 4: ...
   MISC – 5: ...
   MISC – 6: ...
   MISC – 7: ...
   MISC – 8: ...
   MISC – 9: ...
   MISC – 10:...
   MISC – 11:...
   MISC – 12:...
   MISC – 13:...
   MISC – 14:...
   MISC – 15:...
   MISC – 16:...
   MISC – 17:...
   MISC – 18:...
   MISC – 19:...
   MISC – 20:...
   MISC – 21:...
   MISC – 22:...
   MISC – 23:...
   MISC – 24:...
   MISC – 25:...
   MISC – 26:...
   MISC – 27:...
   MISC – 28:...
   MISC – 29:...
   MISC – 30:...
   MISC – 31:...
   MISC – 32:...
   MISC – 33:...
   MISC – 34:...
   MISC – 35:...
   MISC – 36:...
   MISC – 37:...
   MISC – 38:...
   MISC – 39:...
   MISC – 40:...
   MISC – 41:...
   MISC – 42:...
   MISC – 43:...
   MISC – 44:...
   MISC – 45:...
   MISC – 46:...
   MISC – 47:...
   MISC – 48:...
   MISC – 49:...
   MISC – 50:...
   MISC – 51:...
   MISC – 52:...
   MISC – 53:...
   MISC – 54:...
   MISC – 55:...
   MISC – 56:...
   MISC – 57:...
   MISC – 58:...
   MISC – 59:...
   MISC – 60:...
   MISC – 61:...
   MISC – 62:...
   MISC – 63:...
   MISC – 64:...
   MISC – 65:...
   MISC – 66:...
   MISC – 67:...
   MISC – 68:...
   MISC – 69:...
   MISC – 70:...
   MISC – 71:...
   MISC – 72:...
   MISC – 73:...
   MISC – 74:...
   MISC – 75:...
   MISC – 76:...
   MISC – 77:...
   MISC – 78:...
   MISC – 79:...
   MISC – 80:...
   MISC – 81:...
   MISC – 82:...
   MISC – 83:...
   MISC – 84:...
   MISC – 85:...
   MISC – 86:...

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 Table of Contents    
49TH ANNUAL CONFERENCE OF IPSCON-2016
Year : 2021  |  Volume : 53  |  Issue : 7  |  Page : 388-664
 

49th Annual Conference of IPSCON-2016



Date of Web Publication29-Dec-2021

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. 49th Annual Conference of IPSCON-2016. Indian J Pharmacol 2021;53, Suppl S1:388-664

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. 49th Annual Conference of IPSCON-2016. Indian J Pharmacol [serial online] 2021 [cited 2022 Dec 7];53, Suppl S1:388-664. Available from: https://www.ijp-online.com/text.asp?2021/53/7/388/337360





  G. Achari Prize Session: Oral Presentation Top


[TAG:2]G. ACHARI PRIZE SESSION – 1: Inhibition of GSK-3β Protects against Glutamate-Excitotoxicity of Cortical Neurons via PICK1 Regulation

[/TAG:2]

Ashok Kumar Datusalia, Piyush Agarwal, Jitendra Narain Singh, Shyam Sunder Sharma

Department of Pharmacology and Toxicology, National Institute of Pharmaceutical Education and Research, S.A.S. Nagar, Punjab, India

Diabetes increases the risk of stroke, increased morbidity after stroke and cognitive deficits. We hypothesized that insulin resistance in cortical neurons increases the vulnerability towards glutamate-induced excitotoxicity. To mimic insulin resistance, cortical neurons were incubated with high insulin (1μM) and high glucose (25mM added) for 24 hours. Cortical neurons pre-treated with insulin exhibited blunted acute insulin-mediated activation of Akt and GSK-3. Our results indicate that chronic high insulin exposure increase glutamate-induced excitotoxity which can be blocked by insulin receptor antagonist (S961) and GSK-3β inhibitor (SB216763). These inhibitors also ameliorate to pAkt and pGSK-3β downregulation after chronic insulin exposure. Increased expression of PICK1 may explain the increased glutamate-excitotoxicity in insulin resistant cortical neurons. This study results may explain the increased neuronal damage and functional deficits in both experimental and clinical diabetes associated with stroke and cognitive deficits.


  G. ACHARI PRIZE SESSION – 2: A Comparative Study of Efficacy and Safety of Eberconazole versus Terbinafine in Patients of Tinea Versicolor Top


Sharma J, Kaushal J, Aggarwal K1

Departments of Pharmacology and 1Skin, V.D. and Leprosy, Pt. B.D. Sharma PGIMS, Rohtak, Haryana, India

Objectives: Tinea versicolor is characterized by appearance of maculosquamous lesions associated with erythema, scaling and pruritis in characteristic areas of body. Eberconazole and Terbinafine though drugs of different classes provide both mycological and clinical cure. This study was done to compare the efficacy and safety of Eberconazole versus Terbinafine in patients of tinea versicolor. Material and Methods: A prospective, open label, randomized, comparative clinical study was conducted on 40 patients. The patients were randomly divided into two study groups. Group A: Eberconazole 1 % cream once daily and Group B: Terbinafine 1 % cream once daily for 2 weeks. Efficacy assessment was done by observing signs and symptoms i.e. Physician assessment 4-point scale, Microscopic Examination, Wood's lamp examination, Global clinical response assessment & Patient's assessment on Visual Analogue Scale at the end of 2 weeks and subsequently patients were reassessed at the end of 4 and 8 weeks to check any relapse. Safety assessment was also done. Results: In both the groups, all patients were cured on Global clinical assessment scale, at the end of 2 weeks. However, on comparing both the groups at 2 weeks, better improvement was seen with Eberconazole as compared to Terbinafine in Physician assessment score (92.68% versus 79.59%) which was statistically significant (p< 0.05). There was no relapse at the end of 4 & 8 weeks with Eberconazole but one patient had relapse at 8 weeks with Terbinafine. Both drugs had similar safety profile. Conclusion: Although both drugs cured the disease, Eberconazole showed better results.

Keywords: Eberconazole, terbinafine, tinea versicolor


  G. ACHARI PRIZE SESSION – 3: Anti-Diabetic Effect of Selected Histone Deacetylases Inhibitors in Diabetic Rat: Elucidation of Molecular Mechanisms Top


Sabbir Khan, Gopabandhu Jena

Department of Pharmacology and Toxicology, Facility for Risk Assessment and Intervention Studies, National Institute of Pharmaceutical Education and Research, S.A.S. Nagar, Punjab, India

E-mail: [email protected]

Objectives: Recent evidences highlighted the role of histone deacetylases (HDACs) in insulin-resistance, gluconeogenesis and islet function. HDACs can modulate the expression of various genes, which directly or indirectly affect glucose metabolism. This study was aimed to evaluate the anti-diabetic role of short-chain fatty acid HDAC inhibitors, valproic acid (VPA) and sodium butyrate (NaB) in type-2 diabetic rat. Methods: Diabetes was developed in Sprague-Dawley rats by the combination of high-fat diet and low dose streptozotocin. VPA at the doses of 150 and 300 mg/kg/day, while NaB at the doses of 400 and 800 me/kg/day and metformin (positive control) 150 mg/kg twice daily for 10 weeks were administered by oral/i.p route. Insulin-resistance, dyslipidemia and glycemia were evaluated by biochemical estimations, while fat accumulation and structural alteration were assessed by histopathology. Protein expression and insulin signaling were evaluated by western blot and immunohistochemistry. Results: VPA and NaB treatment significantly reduced the plasma glucose, HbA1c, insulin-resistance, fat deposition in brown adipose tissue, white adipose tissue and liver, which are comparable to metformin treatment. Further, VPA and NaB inhibited the gluconeogenesis and glucagon expression as well as restored the histopathological alterations in pancreas and liver. Conclusion: The present findings provide new insights on the anti-diabetic role of HDAC inhibitors (VPA & NaB) in type-2 diabetes by the modulation of insulin signaling and forkhead box protein O1 (FOXO1)-mediated gluconeogenesis. Further, detailed molecular mechanisms of the present findings can be further investigated for possible clinical use.

Keywords: Butyrate, diabetes, gluconeogenesis, histone deacetylases inhibitor, insulin-resistance, valproate


  G. ACHARI PRIZE SESSION – 4: Propolis Attenuates Hepatorenal Oxidative Stress, Antioxidant Status, Histopathology and Ultrastructural Changes in High Fat Diet and Ethanol Treated Rats Top


Hemeshwer Kumar Chandra, Monika Bhadauria, Sangeeta Shukla1

Department of Zoology, Toxicology and Pharmacology Laboratory, Guru Ghasidas University, Bilaspur, Chhattisgarh, 1Department of Zoology, Reproductive Biology Laboratory, Jiwaji University, Gwalior, Madhya Pradesh, India

Alcohol abuse lead the several diseases and millions of death world-wide. High fat diet are major contributor for non-alcoholic liver diseases, liver failure and obesity. This study was carried out to evaluate the protective effect of propolis on combined consumption of high fat diet (HFD) and ethanol induced hepatorenal injuries. Rats were feed HFD 30% and ethanol 10% for 4 week along with different doses of propolis 100, 200 and 400 mg/kg and 50 mg/kg dose of silymarine. Combined consumption of HFD and alcohol increased serum aspartate transaminase, alanine transaminase, alkaline phosphatase, bilirubin, urea, uric acid, creatinine,triglycerides and cholesterol and decrease the glucose and albumin. Administration of propolis restored serum variables towards control. HFD and alcohol increased hepatorenal lipid peroxidation, triglycerides, cholesterol and hepatic ADH, ALDH and CYP2E1; and decreased superoxide dismutase, catalase, glutathione peroxidase, glutathione reductase, glucose-6-phosphate dehydrogenase and glutathione. Administration of propolisaltered all biochemical variables towards control and maintainedhistoarchitecture. Present study concluded that administration of propolismay alleviate HFD and ethanol induced hepatorenal damage through preventing lipid formation, protecting antioxidant system and histoarchitecture due to the presence of phenolic compounds in its extract.


  G. ACHARI PRIZE SESSION – 5: Agmatine Attenuates Prenatal Ethanol Exposure Induced Cognitive and Behavioral Deficits in Rat Offsprings Top


Shreesha Nambiar, Manish Aglawe, Mayur Kale, Madhura Dixit, Dinesh Gawande, Nandkishor R Kotagale, Brijesh G Taksande

Department of Pharmacology, Division of Neuroscience, Shrimati Kishoritai Bhoyar College of Pharmacy, Nagpur, Maharashtra, India

Objective: Alcohol consumption during pregnancy leads to the development of a broad range of neurobehavioral changes including poor intelligence, impaired learning and several neurological symptoms, commonly referred as fetal alcohol syndrome (FAS). Despite high prevalence and severity the neurochemical basis of FAS remains largely unexplored. Thus the objective of the present study was to evaluate the pharmacological effects of agmatine in cognitive deficits associated with FAS in rats' offsprings prenatally exposed to alcohol. Methods: Pregnant rats received ethanol in liquid modified diet during the entire gestational period of 21 days. Offsprings were analyzed for righting reflex, exploratory behavior in holeboard, learning and memory in Morris's water maze (MWM) and fear conditioning response and hippocampal agmatine levels at different postnatal days (PND). Results: Offsprings showed spectrum of behavioral abnormalities, like delayed righting reflex, reduced exploratory behavior, impaired learning and memory in MWM and disrupted fear conditioning response at different postnatal days (PND). These behavioral abnormalities were directly correlated with a significant reduction in hippocampal agmatine levels. Chronic agmatine (40 and 80 mg/kg, ip) administration for 15 days (PND: 21–35), improved exploratory behavior in hole-board test, reduced latency to reach the desired platform location and increased the number of entries as well as time spent in platform quadrant when subjected to MWM test. Agmatine also normalized the disrupted fear conditioning in rats' offsprings exposed prenatally to ethanol. Conclusion: This study provides functional evidences for the therapeutic potential of agmatine in cognitive impairment and other neurological complications associated with FAS.

Keywords: Agmatine, cognitive deficits, fear conditioning, fetal alcohol syndrome


  G. ACHARI PRIZE SESSION – 6: Comparative Study of Supression of Neuroinflammation by Resveratrol and Curcumin in the Experimental Paradigm of Autism Spectrum Disorders Top


Ranjana Bhandari, Anurag Kuhad

Pharmacology Research Laboratory, University Institute of Pharmaceutical Sciences, UGC-Centre of Advanced Study, Panjab University, Chandigarh, India

Objective: Neuronal dysfunction caused as a result of neuroinflammation triggered by the stimulation of matrix metalloproteinases and the subsequent release of pro-inflammatory cytokines is one of the probable mechanisms involved in the pathogenesis of autism spectrum disorders (ASD). The aim of the present study was to compare the ameliorative potential of resveratrol and curcumin on neuroinflammation in the experimental paradigm of neuroinflammatory model of ASD in rats. Methods: 1M Propanoic acid (PPA) (4μl) was infused over 10 minutes into the anterior portion of the lateral ventricle to induce ASD like symptoms in rats. Resveratrol (5, 10 and 15 mg/kg) as well as curcumin (50, 100 and 200 mg/kg) was administered starting from the 2nd day of the surgery and continued upto 28th day. Rats were tested for various behavioural paradigms such as social interaction, stereotypy, locomotor activity, anxiety and novelty, depression, spatial learning and memory, repetitive and pervasive behaviour between the 7th day and 28th day. In addition, biochemical tests for oxidative stress, mitochondrial complexes, TNF-α and MMP-9 were also assessed. Results: Intracerebroventricular injection of propanoic acid produced neurological, sensory, behavioural, biochemical and molecular deficits which were assessed as endophenotypes of autism spectrum disorders. Treatment with resveratrol as well as curcumin for four weeks restored, significantly and dose dependently, all these endophenotypes in PPA induced ASD in rats. It was found that curcumin is more potent antioxidant even at low doses as indicated from its ability to reduce nitrite levels, Complex 4 activity as well as GSH levels. Also its effectiveness in restoring sensorimotor dysfunction, locomotor activity as well as memory and pervasiveness as compared to resveratrol could give an indication of this. Conclusion: The major finding of the study is that though both resveratrol as well as curcumin could restore the core and associated symptoms of autistic phenotype by suppressing oxidative-nitrosative stress, mitochondrial dysfunction, TNF-α and MMP-9 expression in PPA induced ASD in rats. However, on comparison curcumin appears to be more potent antioxident but it needs further investigation.

Keywords: Autism spectrum disorders, curcumin, MMP-9, neurobehavioural, oxido-nitrosative stress, resveratrol, TNF-α


  G. ACHARI PRIZE SESSION – 7: Role of HMG-COA and JAK-2 in the Attenuated Cardioprotective Effect of Ischemic Preconditioning in Hyperlipidemic Rat Heart Top


Gurfateh Singh, Nancy Dhadwal, Rai Barinder Singh, Harikumar SL

Department of Pharmacology, University School of Pharmaceutical Sciences, Rayat-Bahra University, Mohali, Punjab, India

The present study is designed to investigate the possible role HMG-CoA & JAK-2 in the attenuated cardioprotective effect of ischemic preconditioning in hyperlipidemic rat hearts. Rats were administered high fat diet freely for 28 days to produce experimental hyperlipidemia. Isolated Langendorff's perfused normal and hyperlipidemic rat hearts were subjected to global ischemia for 30 min followed by reperfusion for 120 min. Rat heart infarct size was assessed macroscopically using triphenyltetrazolium chloride (TTC) staining. CK-MB & LDH release was analysed from coronary effluent to assess the degree of cardiac injury. Moreover, the oxidative stress in heart was assessed by measuring TBARS, GSH & SOD. The ischemia-reperfusion (I/R) injury has been observed to induce oxidative stress by increasing TBARS and decreasing reduced form of glutathione & SOD in normal and hyperlipidemic rat hearts. Moreover, I/R induced myocardial injury, which assessed in terms of increase in myocardial infarct size, CK-MB & LDH release in coronary effluent and decrease in coronary flow rate in normal and hyperlipidemic rat hearts. In addition, the hyperlipidemic rat hearts showed enhanced I/R-induced myocardial injury with high degree of oxidative stress as compared with normal rat hearts subjected to I/R. Four episodes of IPC (5 min each) afforded cardioprotection against I/R-induced myocardial injury in normal rat hearts which was assessed in terms of improvement in coronary flow rate and decrease in CK-MB, LDH, oxidative stress and myocardial infarct size. On the other side, IPC mediated myocardial protection against I/R-injury was abolished in hyperlipidemic rat hearts. Pre-treatment with Atorvastatin, a selective HMG-CoA reductase inhibitor (10 mg/kg, p.o) & treatment via Langendorff's perfusion with Tyrphostin AG490 (5 μM), a selective inhibitor of JAK-2 markedly restored the cardioprotective effects of IPC in hyperlipidemic rat hearts. At last, it is suggested that the high degree of oxidative stress produced in hyperlipidemic rat heart during reperfusion and consequent activation of HMG-CoA & JAK-2 may be responsible to attenuate the cardioprotective effects of IPC against I/R induced myocardial injury.

Keywords: HMG-CoA, hyperlipidemia, tyrphostin AG490


  G. ACHARI PRIZE SESSION – 8: Unravelling a Novel Therapeutic Strategy for the Management of Nonsteroidal Anti-inflammatory Drug-Induced astroenteropathy: Addressing an Unannounced Emergency Top


Devendra Pratap Singh1,2, Swapnil P Borse1,2, Manish Nivsarkar1

1Department of Pharmacology and Toxicology, B. V. Patel Pharmaceutical Education and Research Development Centre, 1Institute of Pharmacy, NIRMA University, Ahmedabad, Gujarat, India

Objectives: Management of Nonsteroidal anti-inflammatory drug (NSAID)-induced gastroenteropathy is a challenge for the clinicians mainly because antisecretory drugs like proton pump inhibitors although prevent the NSAID-induced gastro-duodenal damage; they rather worsen the enteropathic damage. Importantly, pathogenesis of the disease remains ill defined and there are no approved drugs for NSAID-induced enteropathic damage. Hence, the primary objective of the present work was to assess the effects of quercetin (QCT) administration on NSAID-induced gastroenteropathy and define underlying pathophysiological mechanisms. Methods: Rats were treated twice daily with QCT (12.5, 25, 50 and 100 mg kg-1 peroral) or vehicle for a total of 10 days. In some experiments, diclofenac sodium (DIC; 9 mg kg-1) was administered orally twice daily for the final 5 days of QCT/vehicle administration. After the last dose on 9th day, rats in all the groups were fasted, however, water was provided ad libitum. 12 h after the last dose on 10th day, rats were euthanized and their GI tracts were assessed for haemorrhagic lesions, lipid peroxidation, intestinal permeability and GI luminal pH alterations along with haematological and biochemical estimations. Results: The macroscopic, biochemical, haematological and histological evidences suggested that QCT administration significantly attenuated the NSAID-induced gastroenteropathic damage in a dose dependent manner, with significant effects observed at 50 and 100 mg kg-1. Conclusion: QCT appears to be a promising candidate for the management of NSAID-induced gastroenteropathy and the mechanisms may be related to its ability to prevent the lipid peroxidation, GI blood loss, alterations in GI luminal pH and intestinal permeability

Keywords: Enteropathy, gastroenteropathy, nonsteroidal anti-inflammatory drug, quercetin, rats, ulcers


  G. ACHARI PRIZE SESSION – 9: Antipsychotic Effect of Vaccinium macrocarpon on MK-801 Induced Psychosis in Mice Top


Rajesh A Maheshwari, Disha Shukla, R Balaraman, Kirti Patel1

Department of Pharmacy, Sumandeep Vidyapeeth, 1Faculty of Pharmacy, The M S University of Baroda, Vadodara, Gujarat, India

Objectives: This study was aimed to investigate the effect of aqueous cranberry extract (ACE) on MK-801 induced psychosis in mice. Materials and Methods: Psychosis in mice was induced with MK-801. Psychosis induced mice were treated with ACE (1g/kg and 2g/kg, p.o.) for 14 days. Various behavior parameters and neuro-chemical estimations like DA, 5-HT, NA, GABA, glutamate, Glycine and markers of oxidative stress such as nitrite levels were measured. Results: Psychosis induced mice showed a significant elevation of immobility time in forced swim test, locomotor activity and reduction in time of permanency in rota-rod test, escape latency time in cook's pole test, while treatment with ACE ameliorate MK-801 induced psychosis due to improvement in behavior parameters. Moreover, MK-801 induced psychosis in mice showed a significant increase in DA, 5-HT, NA levels and decrease in GABA, glutamate, Glycine levels in brain. In contrast, treatment with ACE at both doses showed a remarkably altered the neurochemical parameters. In addition, ACE treated mice showed a substantial reduction in AchE activity, DAO enzyme activity and nitrite levels which was elevated by MK-801. Conclusions: ACE at the both doses once for 14 days significantly ameliorated the behavioral symptoms in experimentally induced psychosis, caused neuromodulation and decreased oxidative stress.

Keywords: Aqueous cranberry extract, DA, GABA, MK-801, psychosis, rota-rod test


  G. ACHARI PRIZE SESSION – 10: Anticancer Activity of Psidium guajava Linn against Human Breast Cancer Cell Line and MNU Induced Mammary Carcinogenesis in Rats Top


Prachi D Karia, Laxmi A Patil, Kirti V Patel, Shri SP Rathod

Faculty of Pharmacy, The Maharaja Sayajirao University of Baroda, Vadodara, Gujarat, India

Objective: To evaluate the potential of Psidium guajava Linn. in breast cancer. Methods: To study cytotoxicity of Pulp of Psidium guajava (POPG), MTT assay was performed on MCF-7, MDA-MB-231 and MDA-MB-453 human breast cancer cell line. In-vivo mammary carcinogenesis was induced in nulliparous Sprague-Dawley rats (50 days) by 50 mg/kg methylnitrosourea (MNU). The rats were randomly allocated in 7 groups (n=6): Group I Normal Control, Group II Model Control (MNU), Group III Vehicle Control (MNU+ sesame oil; s.c), Group IV Standard control (MNU + 1mg/kg s.c. Tamoxifen in sesame oil), Group V to VII Test control (MNU+ POPG (100mg/kg, 200mg/kg and 400 mg/kg)). The treatment was given for 100 days. Growth Rate, feed consumption efficiency were measured weekly. Tumor parameters, Estrogen and Progesterone receptor status, antioxidant parameters & nucleic acid content were performed at the end. Scratch assay for metastasis and Chick Chorioallantoic Membrane assay for angiogenesis were performed. Statistical analysis was done by one way and two way ANOVA followed by post hoc Dunnett's test & Bonferroni test respectively. Results: POPG was proven to be more potent cytotoxic in MCF-7 cell line as compared to other two. POPG decreased tumor parameters, expression of Estrogen and Progesterone, nucleic acid content and increased latency period. Antioxidant status was near to normal levels after treatment with POPG. POPG were also found to inhibit metastasis and angiogenesis. Conclusion: POPG exhibited chemo-preventive activities against MCF-7 breast cancer cell line and inhibited growth of mammary carcinoma in-vivo through modulation of estrogen and progesterone receptor.

Keywords: Breast cancer, cell line, methylnitrosourea, pulp of Psidium guajava


  G. ACHARI PRIZE SESSION – 11: Comparison between Antifibrotic Activity of ACE Activator and ACE Inhibitior against Bile Duct Ligation Induced Liver Fibrosis in Rats Top


Dipika S Chavda,Chirag Parikh, Kirti Patel,

Shri SP Rathod

Faculty of Pharmacy, The Maharaja Sayajirao University of Baroda, Vadodara, Gujarat, India

E-mail: [email protected]

Objective: To evaluate the potential of ACE2 activators and ACE inhibitors in liver fibrosis. Methods: In Bile Duct Ligation (BDL) model, male Sprague Dawley rats (250-350 gm) were randomly divided in to 9 groups containing 6animals each. Group I (NC)received normal saline orally, in Group II(Sham Operated-SHAM) bile duct was only identified, but was not ligated and animals of groupIII (MC),group IV (VC),V (XAN-2.5),VI(XAN-5),VII(XAN-10),VIII(LIS),IX(STD)weresubjected to bile duct ligation surgery for induction of liver fibrosis for 15 days followed byone day recovery period. After one day of BDL animals of groups IV-IX were treated with0.2% CMC(VC), Xanthenone 2.5mg/kg(XAN-2.5), 5mg/kg(XAN-5), 10mg/kg(XAN-10)Lisinopril(LIS), Losartan 5mg/kg (STD) daily by oral route for 15 days. Current study involves estimation of various serum parameters, physical parameters, fibroticmarker –Hydroxyproline,histopathology and oxidative stress parameters. The 2 results obtained from all ofthese parameters confirms that BDL and TAA causes liver fibrosis Statistical analysis was done by ANOVA followed by post hoc Bonferroni's test. Results: ACE2 activatorXanthenoneand improved BDL induced changes inserum parameters, physical parameters, fibroticmarker –Hydroxyproline,histopathology and oxidative stress parameters. Conclusion: The present study suggests that xanthenone and lisinopril possesses significant protective effect in treating liver fibrosis.

Keywords: Bile duct ligation, lisinopril, liver fibrosis, xanthenone


  G. ACHARI PRIZE SESSION – 12: Quantification of Quercetin Obtained from Allium Cepa Lam. Leaves and its Effects on STZ Induced Diabetic Neuropathy Top


Une Hemant D, Mohammed Mubashir1, Khan Dureshahwar

Y. B. Chavan College of Pharmacy, Dr. Rafiq Zakaria Campus, Dr. Rafiq Zakaria Marg, 1SDMVM's Dr. Vedprakash Patil Pharmacy College, Aurangabad, Maharashtra, India

E-mail: [email protected], [email protected]

Objective: Antioxidant potential have protective effects in diabetic neuropathy hence the present study was designed with objective to quantify quercetin from shade dried leaves of A. cepa Lam. and to study its effects in STZ induced chronic diabetic neuropathy. Methods: The shade dried leaves of Allium cepa Lam. was extracted with methanol and then fractionated using ethyl acetate (ACEA). The quantification of Quercetin in ACEA was evaluated by HPTLC. The STZ (40 mg/kg) was administered to Sprague-Dawely rats (180-250g) maintained at normal housing conditions. The STZ was administered once a day for three consecutive days. The elevation in blood glucose was monitored for 3weeks periodically using FAD-GDH method by Contour TS glucometer. Rats showing blood glucose above 250 mg/dl were selected for study. Animals were divided into 8groups. ACEA (25, 50 and 100 mg/kg), Quercetin (40mg/kg), Metformin (120mg/kg) and Gabapentin (100mg/kg) were given orally once a day for 2weeks. The blood glucose level was again measured at the end of treatment to assess the diabetic neuropathy. Thermal hyperalgesia, cold allodynia, motor incoordination and neurotoxicity were studied initially and at the end of 2weeks treatment. Biochemical parameters were also evaluated after 2weeks drug treatment. Results: the Quercetin present in ACEA was 4.82% by HPTLC. All the ACEA treatment reduces blood glucose level at the end of 2weeks study and shows significant neuroprotective effect in STZ induced diabetic neuropathy in the above experimental models. Conclusion: The Quercetin present in ACEA proved protective effect in STZ induced diabetic neuropathy.

Keywords: Allium cepa, diabetic neuropathy, HPTLC, STZ


  G. ACHARI PRIZE SESSION – 13: Evaluation of Selected Newer Synthetic Molecule on Cardiac Hypertrophy in Rats Top


Mausam Patel, Amit Patel, Patel, Hardik Gandhi, Prashant Naik, Kirti V. Patel, MR Yadav, Shri SP Rathod

Faculty of Pharmacy, The Maharaja Sayajirao University of Baroda, Vadodara, Gujarat, India

Objective: To evaluate antihypertrophic effect of MCR 414 on unilateral nephrectomy followed by angiotensin-II induced cardiac hypertrophy in rats. Methods: Male Wistar rats (250-350gm) were randomly divided into 10 groups containing 6 animals each. Group I (Normal Control-NC) received normal saline orally, Group II (sham operated-SHAM) kidney was only identified but was not removed. Animals of group III to X were nephrectomised unilaterally; DOCA and NaCl (28 days) and Angiotensin-II (38 days after nephrectomy for 7days) were administered for induction of hypertrophy with 10 days recovery period. Group III was model control, Group IV received 0.1% CMC orally. Groups V-VII received standard losartan 20mg/kg/day;p.o (LOS), standard terazosin 0.5 mg/kg/day;p.o (TERA) & losartan + terazosin 10mg+0.25mg/kg/day;p.o (LOS+TERA) respectively. Groups VIII-X received novel compound MCR 414-2.5mg/kg/day;p.o (MCR 414-2.5), 5mg /kg/day, p.o (MCR 414-5), & 10mg/kg/day;p.o (MCR 414-10) respectively. Hemodynamic parameters, oxidative stress parameters, hypertrophic parameters, ECG, endothelial dysfunction and histopathology were performed. Statistical analysis was done by one way ANOVA followed by post hoc Bonferroni test. Results: MCR 414 improved UN-DOCA-AngII induced hypertrophic changes in blood pressure, LV thickening and endothelial dysfunction. It also improved ECG pattern and antioxidant enzyme levels. All three dose of MCR 414 shows dose dependent effect, MCR 414-10 mg /kg found to be effective. The results were supported by histopathology. Conclusion: Surgically removed unilateral nephrectomy followed by DOCA salt and Angiotensin-II induces cardiac hypertrophy, hypertension, irregular conduction and endothelial dysfunction. MCR 414 combats all these abnormalities and can be used as an alternative for current therapies. Subject code: CVS O D Gulati Prize.

Keywords: Cardiac hypertrophy, hypertension, losartan, MCR 414, terazosin, unilateral nephrectomy


  G. ACHARI PRIZE SESSION – 14: Influence of Accumbal D-Serine Manipulations on Ethanol Withdrawal and Reinstatement Top


Niyamat MA Chimthanawala*, Janhavi D Verma, Rajesh R Ugale

Department of Pharmaceutical Sciences, R.T.M. Nagpur University, Nagpur, Maharashtra, India

E-mail: [email protected]

Objective: To observe the effect of pharmacological manipulations of D-serine, a NMDA co-agonist, within Nucleus Accumbens shell on ethanol withdrawal effect as well as ethanol reinstatement. Materials and Methods: Adult male wistar rats (200-250g) and Swiss albino mice (22-28g) cannulated intra-NAc, were used for ethanol withdrawal and reinstatement experiments respectively. Drugs such as D-serine (30μg, 100μg), Sodium Benzoate (D-Amino Acid Oxidase inhibitor; 100μg), Ifenprodil (NR2B antagonist; 2μg) and TCN-201 (NR1/NR2A antagonist; 1nm) were injected intra-NAc and assessment of somatic signs (rearing, scratching, grooming, paw licking, genital licking, vocalization and chewing) and anxiety was done in ethanol withdrawal rats. Results: D-serine (30μg, 100μg), Sodium benzoate (100μg), TCN 201 (1nm) and Ifenprodil (2μg) significantly decreased the ethanol withdrawal induced hyperlocomotion as well as somatic signs whereas D-serine (30μg, 100μg) and Ifenprodil (2μg) significantly alleviated the withdrawal anxiety using Elevated Plus Maze. Further, D-serine (10μg, 30μg), Sodium Benzoate (30μg, 100μg) and TCN 201 (0.1nm, 1nm) significantly facilitated the ethanol extinction and prolonged reinstatement as observed in conditioned place preference paradigm. Conclusion: The present study demonstrated the pivotal role of D-serine manipulations within NAc in ethanol addiction and suggests a better therapeutic target in the treatment of alcoholism.

Keywords: D-serine; ethanol; withdrawal; extinction; reinstatement


  G. ACHARI PRIZE SESSION – 15: Evaluation of Antimalarial Efficacy of Novel Derivatives of Chalcones; an In vitro and In vivo Study Top


Shweta Sinha, Bikash Medhi1, Daniela I Batovska2, BD Radotra3, Rakesh Sehgal

Departments of1Medical Parasitology, 1Pharmacology and 2Histopathology, PGIMER, Chandigarh, India, 3Institute of Organic Chemistry with Centre of Phyto Chemistry, Bulgarian Academy of Sciences, Sofia, Bulgaria

Malaria is one of the most prevalent infectious diseases among sub-Saharan African region, and causing an estimated 0.7-1 million deaths per year all over the globe. Even though the disease is preventable and curable, but appearances of resistance to available medicine especially in south East Asian region of the world necessitate the development of novel drugs. To this concern Chalcones (1, 3, diaryl-2-propen-1-ones) which belongs to flavonoids family has gain attention from past decades for its anti-malarial activity. The present study involves the screening of a series of new chalcone derivatives against Plasmodium falciparum chloroquine sensitive and chloroquine resistant strain under in vitro conditions and screened ones were further observed for its antimalarial activity in in vivo malaria models infected with rodent Plasmodium strain. The three most potent chalcone derivatives screened from in vitro study, i.e. A41, AV21 and AV27 were then administered at most optimum dose (10mg/kg, 10mg/kg, 20mg/kg) for five days following parasitemia of 10-20%. The standard treatment followed in the study was chloroquine (10mg/kg). Various parameters, like parasitemia, body weight, temperature, and effect of treatment on weight of liver and spleen as well as histopathological analysis were determined using standard Rane's test. Most of the Chalcone derivatives evaluated in this study have IC50 value < 0.60 μg/ml against both strains and one of the derivatives A41 has percentage inhibition of 94.24±2.12 on chloroquine sensitive strain. Further, in in vivo malaria models highly significant result at the fifth day of treatment with all the three chalcones A41, AV21 and AV27 as compared to non-treated group (p<0.001) in terms of parasitemia were obtained. Histopathological sections of liver and spleen showed accumulation of more malaria pigment in non-treated group as compared to treated. All these observations suggest that these chalcone derivatives could be an interesting lead compound in the development against malaria. However, further studies are needed to study the safety profile of these derivatives.

Keywords: Chalcones, Malaria, in vitro, in vivo

[TAG:2]G. ACHARI PRIZE SESSION – 16: Evaluation of Anti-Inflammatory Activity of a Plant Protein Crinumin, an Anti-Platelet Agent, for the Treatment of Atherosclerosis [/TAG:2]

Uddipak Rai, Amrita Rawal, Sanjay Singh

Department of Pharmaceutics, Indian Institute of Technology (BHU), Varanasi, Uttar Pradesh, India

Objective: The present study was designed to explore the anti-inflammatory activity of an anti-platelet agent crinumin, by various in-vitro and in-vivo inflammation models. Methods: Firstly, crinumin protein was purified through cation exchange chromatography then, in-vitro activity was estimated by albumin denaturation assay and HRBC membrane stabilization assay. Carrageenan induced paw edema (CIPE) and cotton pellet induced granuloma (CPIG) models were used for in-vivo anti-inflammatory activity assessment in rats. In both models, rats were pre-treated for 7 days with crinumin (25&50μg/ml) and diclofenac sodium (50μg/ml). Expression of P-selectin (in serum and plasma) through ELISA and NF-κB (in paw and granulomatous tissues) through western blotting was checked. Histopathology was done to evaluate the extent of inflammation in treated as well as control animals. Results: It was observed that crinumin significantly (P<0.05) inhibited albumin denaturation and protected lysis of RBC membrane. Crinumin at both concentration (25 or 50 μg/kg of b.w.) significantly (P < 0.05) reduced the paw edema formation in a dose-dependent manner in the second phase of inflammation and significant (p<0.05) reduction of wet weight and dry weight of granuloma was observed indicating the anti-inflammatory potential of crinumin. Crinumin decreased the expression of P-selectin and NF-κB indicating its potential role in decreasing platelet activation and healing inflammation. Histopathological studies, additionally proved the efficacy of drug in treating inflammation. Conclusion: The results of the study suggests that the crinumin might have an inhibitory role in atherosclerosis as platelet aggregation and inflammation are the key processes involved in atherosclerotic disorders.

Keywords: Atherosclerosis, carrageenan, crinumin, platelet aggregation, P-selectin


  U.K. Sheth Prize Top



  U.K. SHETH PRIZE – 1: Comparative Evaluation of Efficacy of Fexofenadine in Autologous Serum Skin Test Negative and Autologous Serum Skin Test Positive, Chronic Urticaria Patients Top


Purohit G, Srivastav B, Agarwal S1, Gaur S

Departments of Pharmacology and 1Dermatology, Susheela Tiwari Hospital, Government Medical College, Haldwani, Nainital, Uttarakhand. India

Introduction: Chronic Urticaria is a common dermatological disorder, characterized by spontaneous wheal, recurrent pruritic and eythematous lesions that persist for more than six weeks. It has major impact on quality of life. Autologous serum skin test (ASST) has been internationally adopted as clinical test to demonstrate the circulating auto antibodies. First and second generation antihistamines are the main stay of treatment. Fexofenadine, a metabolite of terfinadine is a second generation antihistamine mainly used in allergic rhinitis and urticaria. Aim: To compare and evaluate the efficacy of fexofenadine in Autologous serum skin test negative and positive chronic urticaria patients, relationship of ASST Negative and positive patients with angioedema, correlation with thyroid, atopy or asthma, effect of therapy on urticaria activity score and life quality index. Materials and Methods: Unicentre, Open labeled, prospective, comparative clinical study which was undertaken for a study period of 1 year i.e. from September (2014 -2015) in the department of Pharmacology and outpatient department of Dermatology. The study population involved naïve chronic urticaria patient, who were subjected to ASST and grouped into ASST Negative and Positive. Results: In 66 patients of chronic urticaria, ASST was negative in 47% and positive in 53%.Female to male ratio was 2:1, mainly the adult group (31-45 years) was affected, angioedema was present in 54.3% and 35.5% of ASST positive and negative respectively. Family history and thyroid correlation was present in 31.4% and 22.9% of ASST Positive patients respectively. Fexofenadine proved to be effective in both the groups, the urticaria activity score found to be statistically significant (p=0.029) and significant (p=0.001) improvement in absolute eosinophil count(AEC) were seen in both the groups with marked improvement in Life quality index. Conclusion: Chronic urticaria cannot be cured but can be controlled effectively with second generation antihistaminics. ASST can be considered a screening test which can minimize the burden of other lab investigations. ASST negative and ASST positive showed no statistically significant difference for epidemiological details, although our study revealed there is need of additional antihistaminics more in ASST positive group. Improvement in UAS proves that chronic urticaria can be significantly controlled by fexofenadine, few cases might need additional therapy. UAS is proved to be an important tool to assess the severity of disease and to decide the line of management.

Keywords: Autologous serum skin test, chronic urticarial, fexofenadine, urticaria activity scores.


  U.K. SHETH PRIZE – 2: Study of the Appropriateness of Prescribing in Geriatric Patients in a Tertiary Care Hospital of Odisha Top


Panigrahi Mousumee, Swain Trupti R, Moharana Dhirendranath

Departments of Pharmacology and Geriatrics, SCB Medical College, Cuttack, Odisha, India

Objectives: Various screening tools are there to identify potentially inappropriate prescribing (PIP) in older people. Beers' criteria are the most widely used but have disadvantages. New PIP screening tools called Screening Tool of Older Person's Prescriptions (STOPP) and Screening Tool to Alert doctors to Right Treatment (START) have been developed to identify PIPs and potential prescribing omissions (PPOs).The aim was to measure the prevalence rates of PIPs and PPOs in tertiary care using Beers' criteria, STOPP and START. Methods: Case records of 100 patients >65 years old from the geriatric medicine department of a tertiary care hospital of Odisha were studied. The mean age+ SD of the patients was 71.7+7.2 years, 76% were male. Patients' current diagnoses and prescription medicines were reviewed and the Beers' criteria, STOPP and START tools were applied. Results: The total number of medicines prescribed was 851; median number of medicines per patient was seven. The mean Charlson Comorbidity Index of the patients was 4.21+1.85. Overall, Beers' criteria identified 96 PIPs in 67% (67) of patients, whilst the corresponding IP rate identified by STOPP was 33% (33), in respect of 43 PIPs. A total of 22 PPOs were identified in 16% (16) of patients using the START tool. Conclusions: Potentially inappropriate drug prescribing and errors of drug omission are highly prevalent among older people visiting the tertiary care hospital. Prevention strategies should involve incorporation of screening tools by doctors so as to reduce the adverse drug events, polypharmacy, economical burden on patients and increase the quality of life and compliance of patients.

Keywords: Appropriateness of prescriptions, Beers' criteria, geriatrics, Screening Tool of Older Person's Prescriptions/Screening Tool to Alert doctors to Right Treatment


  U.K. SHETH PRIZE – 3: Prospective Comparative Study to Evaluate Efficacy, Safety and Cost Effectiveness of Diclofenac and Their Combination with Various Proteolytic Enzymes in Orthopaedic Department of Tertiary Care Teaching Hospital Top


Hetal V Kacha, Amita R Kubavat, Shailesh G Mundhava

Department of Pharmacology, P.D.U. Govt. Medical College, Rajkot, Gujarat, India

Objectives: To evaluate efficacy, safety and cost effectiveness of diclofenac, serratiopeptidase and chymotrypsin/trypsin as add on in reducing swelling and pain following upper and lower limb fracture. Methodology: This is a prospective, observational study Including 150 patients with upper and lower limb fractures admitted in orthopaedic department of tertiary care teaching hospital. Patients were randomly divided into 3 groups (50 of each), Group-1 tablet diclofenac prescribed, group-2 tablet serratiopeptidase with diclofenac prescribed and group-3 tablet chymotrypsin/trypsin with diclofenac prescribed. Evaluation of swelling reduction was made by using tape measurement. Pain was assessed by using visual analogue scale at day 0, then daily upto 5 days. Adverse drug reactions were also recorded. Results: Reduction of swelling within group was significant (P=<0.0001). Comparison of reduction of swelling in all three groups was statistically not significant (p > 0.05). Reduction in pain score in three groups was significant, but decrease was more in group 1. Cost of therapy was more in group 2 and group 3 as compared to group 1. Conclusion: Patients in Group 2 and 3 showed more anti-inflammatory effect than of group1. However it is not statistically significant. Diclofenac showed more analgesic effect as compared to proteolytic enzymes. Cost of therapy in group 2 and 3 is more. Mild to moderate adverse effects were reported in group 1 and 2. Most common side effect reported was gastritis, in group1.

Keywords: Analgesics drugs, anti-inflammatory, inflammation in postopeartive fractures, proteolytic enzymes


  U.K. SHETH PRIZE – 4: A Study of Prescribing Pattern and Quality of Life in Patients of Metabolic Syndrome in North Indian Population Top


Prashant, Anita Gupta, Vijay K Sehgal, Raghuvansh Kumar1

Department of Pharmacology, Government Medical College, 1Department of Endocrinology, Rajindra Hospital, Government Medical College, Patiala, Punjab, India

Objective: The aims and objective of the present study were: To study the prescription patterns in diagnosed patients of metabolic syndrome (MS). To study the quality of life (QoL) in diagnosed patients of metabolic syndrome. Methods: This was an observational, cross sectional study in which prescriptions were collected from diagnosed MS patients attending the Medicine OPD of GMC and Rajindra Hospital, Patiala. The patients were included in this study as per the necessary inclusion and exclusion criteria. The required information was noted. A total of one hundred prescriptions were analyzed according to WHO core prescribing indicators. The QoL was measured using MOS SF36 criteria in seventy- five patients of MS. All the observations thus made were statistically analyzed using appropriate tests. Results: Prescription patterns: The prescriptions were analyzed according to WHO core prescribing indicators. Average number of drug per prescription was 5.64, percentage of drugs prescribed by generic name was 3.19%, percentage of prescriptions with an antibiotic was 3%, and percentage of prescriptions with an injection was 8%. The total percentage of drugs from essential drug list was 52.62%. Average drug cost per encounter was 44.28 INR. Quality of life: The QoL was measured using MOS SF36 criteria. The patients with MS had an overall poor QoL in comparison to those without it in terms of both physical and mental summary scores. Conclusions: Our findings suggest that patients with MS have clustered components, like obesity, diabetes, hypertension, and dyslipidemia which bear a close reflection on the prescribing patterns. Polypharmacy is quite common in the prescriptions of MS. The patients with MS have an overall poor QoL in comparison to those without it.

Keywords: Diabetes mellitus, metabolic syndrome, prescription patterns, quality of life


  U.K. SHETH PRIZE – 5: An Evaluation of Trigger Tool Method for Adverse Drug Reaction Monitoring at a Tertiary Care Teaching Hospital Top


Urmila Menat, Chetna Desai, Jigar Panchal, Mira Desai, Shivani Patel1, Asha Shah1

Departments of Pharmacology and 1Medicine, B.J Medical College, Ahmedabad, Gujarat, India

Objective: To evaluate the trigger tool method and identify common triggers for detection of adverse drug reactions at a tertiary care hospital in India. Methods: A continuous, prospective, single center study was carried in 400 out of 1245 inpatients from two medical units at a tertiary care teaching hospital in India. A list of trigger tools comprising 20 drug triggers, 28 laboratory triggers and seven patient triggers was compiled from the Institute of Healthcare Improvement (IHI) Global trigger tool and trigger tools used by Abideen P et al and evaluated among the the inpatients. Prescriptions, laboratory investigations and history of patients were monitored for presence of triggers and their association, if any, with adverse drug reactions. Data was analyzed for association of triggers to ADRs (PPV) while descriptive analysis was used to evaluate the ADRs. Results: A total 327 (81.75%) cases showed at least one trigger and no trigger were detected in 73 (18.25%) cases. Of the 327 cases with triggers, ADRs detected in 63 (15.75%) cases. No ADR was detected in 264 (66%) cases i.e a total 15.75% patients suffered one or more ADRs. Of the 55 triggers, 33 triggers were noted 1202 times in these patients, of which 19 were associated with ADRs. The overall positive predictive value of these triggers was 19.26%, while the PPV ranged from 0 to 100% for individual triggers. Conclusion: The trigger tool is an useful method for detection and monitoring of ADRs. Triggers vary in each healthcare setting and the set of triggers should be defined in each healthcare setting, for better ADR monitoring.

Keywords: Adverse drug reaction monitoring, adverse drug reactions, Institute of Healthcare Improvement Global Trigger Tool, pharmacovigilance


  U.K. SHETH PRIZE – 6: A Systematic Analysis of Fixed Dose Combinations Recently Declared Irrational Top


Rimple Jeet Kaur, Jaykaran Charan, Surjit Singh, Pradeep Driwedi, Pramod Sharma, Sneha R Ambwani

All India Institute of Medical College, Jodhpur, Rajasthan, India

Objective: In March 2016, Central Drugs Standards Control Organization declared 1091 fixed dose combination formulations irrational based on the report of expert committee. The aim of the present study is to systematically evaluate this report and observe the leading causes for irrationality of FDCs and see which therapeutic areas are most affected by the irrational FDC formulations. Materials and Methods: The report of expert committee available on CDSCO website was systematically analyzed. 1091 FDC formulations that were recommended for ban by the expert committee were evaluated in this study. Primary areas of focus were: the basis provided by expert committee for considering these FDC formulations irrational and the therapeutic areas for which these irrational combination were used. Descriptive statistics are reported in the form of frequency and percentages. Results: Most common cause for labeling FDCs irrational was safety (26.08%). Other leading reasons were incompatible pharmacodynamics (18.53%), increased adverse drug reactions and toxicity (11.32%), incompatible pharmacokinetics (10.48%). Maximum FDCs were found to be for respiratory diseases (45%). Other areas with a large number are infectious diseases (19.5%), pain management (9.2%) and skin infectious diseases (9.5%). Conclusion: The presence of irrational FDC formulations in the market may expose patients to an extended risk of adverse drug reactions. In the case of antibiotics, injudicious use may lead to resistance that is already burning global issue. Drug laws should be amended to ensure that only safe and effective drugs are available in India.

Keywords: Antibiotic resistance, central drugs standards control organization, drug regulatory authority, fixed dose combinations, irrational


  U.K. SHETH PRIZE – 7: Enhanced oral Bioavailability of Atorvastatin with Green Tea extract: A study by In situ and In vivo Models in Rats and In vivo in Healthy Human Volunteers Top


Prasad Neerati

Department of Pharmacology, DMPK and Clinical Pharmacology Division. University College of Pharmaceutical Sciences, Kakatiya University, Warangal, Andhra Pradesh, India

E-mail: [email protected]

Objectives The aim of the present study was to assess possible beneficial effects of green tea extract on the permeability and absorption kinetics of atorvastatin in rats and exploring beneficial effects in healthy human volunteers. Methods Male Wistar rats used, in in situ study: three groups (n=6), where in group 1 perfused with atorvastatin 30 μM/ml as control, group 2 and 3 coperfused with verapamil 200 μM/ml and green tea extract 10 mg/ml respectively then the effective permeability of atorvastatin was determined. In in vivo study: three groups (n=6), where in group 1 treated with atorvastatin 20 mg/kg (po) as control, group 2and 3 pre-treatment with verapamil 25 mg/kg (po) and green tea extract 10 mg/kg (po) respectively for 7 days, on 8th day atorvastatin was repeated then pharmacokinetics was studied. These results were explored on 24 healthy human volunteers, the randomized crossover trial was carried with atorvostatin 40 mg/kg (po) for 11 days to check the improved bioavailability of the atorvastatin by pre-treatment with green tea extract capsules 400mg. Blood samples were collected between 0.5&24 hours on day-1 and also on Day-11 and analysed by RP HPLC. Results Effective permeability of atorvastatin has been increased by green tea extract in in situ studies. Significant increase in Cmax, bioavailability were increased in human volunteers. Conclusions: Oral bioavailability of atorvastatin is incerased with green tea extract is due to the P-gp inhibition. Additional long term studies on patients is required to correlate the beneficial effects of combination with green tea extract.

Keywords: Atorvastatin, bioavailability, green tea extract, P-gp inhibitor, pharmacokinetics

[TAG:2]U.K. SHETH PRIZE – 8: An Evaluation of Drug Induced Liver Injuries in HIV Positive Patients at a Tertiary Care Hospital [/TAG:2]

Shah SD, Desai CK, Kapadia JD, Desai MK

Department of Pharmacology, B .J .Medical College, Ahmedabad, Gujarat, India

Objectives: To evaluate the pattern of Drug Induced Liver Injuries (DILI) in HIV positive patients. Methods: This prospective single centre observational study was conducted with permission from Institutional Ethics Committee, NACO and patients' informed consent. Patients fulfilling the inclusion criteria for DILI as per CIOMS guidelines (SGPT and/or alkaline phosphatase more than twice the upper limit of normal) were enrolled and evaluated for laboratory parameters, clinical signs and symptoms for 6 months. Patients with Hepatitis B or C co-infection and those not willing to participate were excluded. Results: Total 75 patients over a period of 12 months were enrolled in the study. Hepatocellular, Cholestatic and Mixed type of liver injuries were observed in 17(23%), 45(60%) and 13(17%) patients respectively. TLE (n=48) and ZLN (n=22) were the commonest antiretroviral regimens used in these patients. Overt clinical symptoms of hepatitis were observed in 20 (27%) patients. Severity (assessed by ACTG criteria) was Grade 1 and 2 in 35(46%) and 30(40%) patients respectively while Severe DILI of Grade 3 and 4 was observed in 8(11%) and 2(3%) patients respectively. Out of the 51 patients with efavirenz based regimen, 24 (48%) suffered from DILI within 4 weeks of starting the regimen. Causality of ADRs (assessed by RUCAM Scale) was Probable (13), Possible (61) and Unlikely (1). Conclusion: Early onset cholestatic type of liver injury is observed in patients receiving efavirenz based ART is not always associated with clinical signs and symptoms. Hence early laboratory monitoring is recommended in these patients.

Keywords: Antiretroviral drugs, drug induced liver injuries, hepatotoxicity, HIV, RUCAM


  U.K. SHETH PRIZE – 9: Comparison and Evaluation of Efficacy of Amlodipine and Cilnidipine on Left Ventricular Hypertrophy and Cardiac Systolic Function Amongst Hypertensive Patients: An Observational Study Top


Sougata Sarkar, Vartika Srivastava, Manjushree Mohanty, KP Tripathy1

Departments of Pharmacology and 1Medicine, Kalinga Institute of Medical Sciences, Bhubaneswar, Odisha, India

Context: Left ventricular hypertrophy is one of the commonest cardiac sign seen in hypertensive patients. According to AHA and JNC VIII calcium channel blockers are first line drug in treatment of hypertension. The equipotent antihypertensive effect of Cilnidipine and Amlodipine in their eqivalent dose has been demonstrated in number of studies. Different meta analysis showed that calcium channel blocker can reduce left ventricular mass by 9-11%. Aims: To compare and evaluate the effects of calcium channel antagonists Amlodipine and Cilnidipine on echocardiographic LVH parameters i.e LVM, LVMI, RWT and cardiac systolic functional parameters i.e eFS, EF amongst hypertensive patients Settings and Design: This is a comparative, non blinded, single centred, prospective and parallel groups, observational study, conducted in medicine OPD clinic of KIMS over a period of 24 months. The study was approved by the Institutional Ethical Committee, KIMS, BBSR Materials and Methods: Total 62 patients were screened and examined, amongst them 48 patients were selected and enrolled as study participants during that period. The enrolled patients were then divided as (1) Hypertensive patient (n=22) - selected patients received either Amlodipine (2.5 to 10mg) or cilnidipine (5 to 20 mg) with or without ARB. (2) Hypertensive with controlled diabetic patients (n=26) - selected patients received either Amlodipine (2.5 to 10mg) or cilnidipine (5 to 20 mg) with or without ARB alongwith antidiabetic medication. Statistical Analysis Used: All values were expressed as means ± SD. Statics applied is unpaired t test and paired t test. Predetermined clinically relevant margin was 10% reduction on LVM and LVMI and 6.5% reduction on RWT from baseline value. Significance is set at P ≤ 0.05. Results: Amlodipine and Cilnidipine, both can reduce LVM, LVMI and RWT with statistical significance but without any clinical relevance when compared with the baseline. The total mean reduction in percentage of above parameters was more with Cilnidipine treated arm than Amlodipine. There was no significant change in eFS and EF seen by either Amlodipine or Cilnidipine when compared with the baseline as well as while comparing both treatment arm. Conclusions: From this study it can be concluded that Cilnidipine is better in reducing LVH than Amlodipine in hypertensive patients without any deleterious action on systolic function

Keywords: Amlodipine, cilnidipine, EF, eFS, hypertension, left ventricular hypertrophy, LVM, LVMI, RWT, systolic dysfunction


  U.K. SHETH PRIZE – 10: Role of Plasma Biomarkers Aβ1–40 and Aβ1–42 Amyloid Peptides in Diagnosis of Alzheimer Disease Top


Soni H, Medhi B, Modi M,Goyal MK, Mohanty M, Vishny VY

Post Graduate Institute of Medical Education and Research, Chandigarh, India

Background In Alzheimer's disease (AD) the pathological events start with formation of small, soluble oligomers of Aβ1-42 in the brain.The overproduction and accumulation of amyloid-beta (Aβ) peptides Aβ1–40 and Aβ1–42 in plaques is the central event in the pathophysiology of AD leading to the formation of neuritic plaques and neuronal death. In present study we have used plasma level of Aβ1–40 and Aβ1–42 amyloid peptides in diagnosis of AD. Materials and Methods We screened 152 patients with memory complained in outpatient department of neurology, between sept 2014 to nov 2015 and enrolled 47 old aged (>50yrs) demented patients who fulfilled the DSM-IV criteria for dementia, diagnostic criteria for AD (Dubos criteria) and MCI diagnostic criteria with adequate vision and hearing. Aβ1–40 and Aβ1–42 plasma level were estimated by ELISA kit. Results: In AD patients, the mean value of Aβ1-42 was 2.302 ± 1.5654ng/ml. It was 1.608 ±0.3551 ng/ml in MCI group and 1.647 ± 0.6216 ng/ml in control group. Plasma Aβ1-42 level was significantly high in AD patients as compared to controls. Conclusion: Inthis study, the plasma amyloid peptide Aβ1−40 and Aβ1-42 by ELISA method failed to show good sensitivity inspite of statistical significant difference from AD to controls. So these amyloid peptide should not be used as an additional diagnostic biomarker in the Alzheimer disease.

Keywords: Alzheimer disease, amyloid peptides, amyloid precursor protein, dementia, mild cognitive impairment, neurodegenerative disease, plasma biomarkers

[TAG:2]U.K. SHETH PRIZE – 11: High Salt Diet-Induced Cardiovascular and Renal Dysfunction in Uninephrectomized Rats: Involvement of RAS, SERCA, AMPK and AKT [/TAG:2]

Venkateswara Rao Amara, Sunil Kumar Surapaneni, Kulbhushan Tikoo

Department of Pharmacology and Toxicology, Laboratory of Epigenetics and Diseases, National Institute of Pharmaceutical Education and Research, S.A.S. Nagar, Punjab, India

Objectives: No major adverse cardiovascular and renal events were reported in live kidney donors. Excessive salt intake leads to pressure-dependent and independent cardiovascular and renal complications in binephric (normal) scenario. No data is available depicting the effect of high salt diet on the quality of life of live kidney donated people. Hence, we undertook the present study to determine the effect of high salt diet on the cardiovascular and renal functions of uninephrectomized rats. Methods: To exactly mimic the clinical setting, male Sprague Dawley rats (200-250g) were uninephrectomized, initially fed normal pellet diet (NPD) for 12 weeks and then for 20 weeks with 10 % w/w high salt diet. Biochemical, cardiovascular functional parameters were assessed. Fibrosis was quantified in kidney, heart and aorta. Western blotting in heart was carried out to check the expression of proteins. Results: High salt diet impaired cardiac and renal functions, increased in vivo cardiovascular reactivity to Ang II owing to rendezvous between increased Ang II type 1 receptors (AT1Rs) and L-type calcium channels (LTCCs), cardiovascular fibrosis in uninephrectomized rats. SERCA, p-AMPK decreased and p-AKT increased significantly in the heart of uninephrectomized rats fed with high salt diet. Conclusions: Cardiovascular and renal functions, which were normal in uninephrectomized rats, were worsened when fed with high salt diet. Cardiovascular dysfunction involves alteration of cardiac SERCA, p-AMPK, p-AKT and dysregulated renin-angiotensin system. This study highlights the harmful effects of high salt and suggests the restriction of salt intake in live kidney donors.

Keywords: Heart, kidney, L-type calcium channels, renin-angiotensin system, uninephrectomy


  Manjeet Singh Prize Top



  MANJEET SINGH PRIZE – 1 : Carvedilol Prevents Functional Deficits in Peripheral Nerve Mitochondria in Rats with Oxaliplatin-Evoked Painful Peripheral Neuropathy Top


Aparna A, Prashanth K, Karthika N, Ashutosh Kumar

Department of Pharmacology and Toxicology, National Institute of Pharmaceutical Education and Research, Hyderabad, Telangana, India

E-mail: [email protected]

Objectives: Oxaliplatin is a chemotherapeutic agent characterized by peripheral neuropathy which hampers its usage. Evidence suggests that neurotoxic effect is due to oxidative stress and mitochondrial dysfunction in peripheral nerves and dorsal root ganglion (DRG). Carvedilol is an antihypertensive drug, proved for its antioxidant, mitoprotective and neuroprotective properties. We aimed to study the effect of carvedilol on the function of peripheral nerve mitochondria in the experimental model of oxaliplatin-induced peripheral neuropathy (OIPN). Methods: Carvedilol at a dose 10 mg/kg p.o. was administered for 4 weeks daily in oxaliplatin (4 mg/kg twice weekly for 4 weeks, i.p.) induced neuropathic rats. Functional and behavioural deficits were assessed by nerve conduction velocity, hyperalgesia and allodynia. Sciatic nerve and DRG were collected to assess the levels of oxidative stress, mitochondrial function, immunohistochemical and western blotting analysis. Neuroprotective effect was compared with a standard antioxidant, α-lipoic acid (100 mg/kg, i.g.). Results: Oxaliplatin significantly (p < 0.001) reduced the sensory nerve conduction velocity and produced the thermal and mechanical nociception. Carvedilol treatment prevented these oxaliplatin-induced deficits and counteracted the lipid peroxidation and nitrosative stress. It also improved the mitochondrial function; restored membrane potential thus prevented apoptosis. The levels of nitrotyrosine were reduced and increased the MnSOD expression in both sciatic nerve and DRG tissues. Carvedilol produced a similar effect to that of α-lipoic acid and no significant changes were observed in alone treated (10 mg/kg p.o.) rats when compared to normal rats. Conclusions: Carvedilol association with oxaliplatin treatment was suggested as a possible strategy to prevent the OIPN.

Keywords: Carvedilol, mitochondrial dysfunction, oxaliplatin, peripheral neuropathy and dorsal root ganglion


  MANJEET SINGH PRIZE – 2: Noladin Ether and Naloxone Synergistically Improve Striatal Dopamine Levels and Corrects Motor Abnormalities in MPTP-Infused Rats Top


Rahul Deshmukh, Priya Jaswal

Neuropharmacology Division, I.S.F. College of Pharmacy, Moga, Punjab, India

E-mail: [email protected]

Objective: Cannabinoid CB1 and mu opioid receptors are densely co-expressed in striatal neurons; together these may influence dopaminergic signaling in basal ganglionic circuitry and modulate motor functions. The purpose of the current study was to identify the role of striatal CB1 and mu opioid receptors in dopaminergic signaling and their influence on motor functions. Methods: MPTP (100μg/1μl) was infused intranigrally (bilaterally 0.5μl/minute) on day 1, 4 and 7 in rats and the animals to were treated with morphine, naloxone, AM251, WIN55, 212-2 and noladin ether as mu opioids and CB1 receptor modulators respectively, alone or in combination. Movement abnormalities were assessed by grip strength, narrow beam walk, open field etc. Striatal brain tissue homogenate was used to determine the levels of dopamine, GABA and glutamate. Results: The present study revealed that the repeated MPTP-infusion in rats produce stable motor deficit and cause significant alterations in striatal neurochemistry. The pharmacological interventions used in the current study had a significant impact on motor functions and brain neurochemistry. Co-administration of noladin ether with naloxone significantly attenuated MPTP-induced behavioral and neurochemical alterations in rats. Conclusion: Current study revealed that the mu opioid receptors may negative influence over CB1 receptor signaling and the positive regulation of CB1 receptors may be required for the movement control in the basal ganglionic circuitry. Our results clearly indicate that the blockade of mu opioid receptors may promote CB1 receptor signaling, which also help to correct the disturbed striatal neurochemistry and thus attenuate MPTP-induced motor deficit in rats.

Keywords: 212-2, cannabinoid receptors, endocannabinoid system, MPTP, Opioid receptors, Parkinson's disease, WIN55

[TAG:2]MANJEET SINGH PRIZE – 3: Selective ER-α Activation Mitigates Vascular Endothelial Dysfunction in Diabetic Ovariectomized Rats: Pivotal Role of eNOS [/TAG:2]

Seema Bansal, Kanwaljit Chopra

University Institute of Pharmaceutical Sciences, Panjab University Chandigarh, India

Background: Diabetes mellitus is common in postmenopausal women and is a major risk factor for cardiovascular disease, the leading cause of mortality. Protective effect of estrogen in vascular endothelial dysfunction has been well reported. However, these protective effects appear to be absent in women with diabetes, may be due to, differential activation of ER-α and β during disease conditions such as diabetes. Objectives: The main aim of our study was to characterize the specific estrogen receptor which could be selectively targeted to achieve vasculoprotection in postmenopausal diabetic situation. Methods and Results: A significant impairment in glycemic and lipid profile, decreased ACh- induced endothelium dependent relaxation, impaired endothelial integrity, and rise in inflammatory and oxidative stress markers were observed in ovariectomized diabetic rats as compared to sham rats. These markers were further correlated with aortic eNOS levels. Treatment with selective ER-α receptor agonist markedly while 17-β estradiol partially ameliorated these alterations along with enhanced aortic eNOS levels. However, ER-β agonist did not show any such effect. Our data suggests that selective ER-α activation mitigates endothelial dysfunction in diabetic ovariectomized rats via activation of eNOS. Conclusions: The findings indicate that ER-α could be an important pharmacological target, to mimic the beneficial effect of estradiol in cardiovascular disorders, especially in postmenopausal diabetic women.

Keywords: Estrogen receptor agonists, menopause, type 2 diabetes


  MANJEET SINGH PRIZE – 4: Modification of Cardio-Metabolic Syndrome by Garcinia indica in Rats Top


Chaudhari Jaimin, Bhumika Sharma, Sagar Patel, Kirti V Patel, Shri SP Rathod

Faculty of Pharmacy, The Maharaja Sayajirao University of Baroda, Vadodara, Gujarat, India

Objective: To evaluate the potential of Garcinia indica in cardio-metabolic syndrome. Methods: Wistar rats of 6-8 weeks (250-350g) were used. Model control (MC)- I receive (20% Fructose in drinking water for 45 days), MC–II (Methionine(1g/kg, p.o.) suspended in 1% Sodium CMC for 45 days) and MC–III(20% fructose in drinking water + methionine(1g/kg, p.o.) for 45 days). Standard treatment group received received 20% fructose in drinking water + methionine(1g/kg, p.o and lisinopril (10mg/kg, p.o.) + Atorvastatin (10 mg/kg, p.o.) + Metformin(50 mg/kg, p.o.). Test treatment group received 20% fructose in drinking water + methionine(1g/kg, p.o.) and respective treatment of GIME at doses 200mg/kg,400mg/kg and 800 mg/kg respectively. Body weight was measured weekly while water intake was measured daily. serum lipid levels and Blood glucose were measured every 15 days. On 45th day serum lipid, glucose, OGTT, serum insulin levels, blood pressure, arterial reactivity, endothelial dysfunction, liver function markers, antioxidant parameters and histopathology were performed. Results: Garcinia Indica methanolic extract improved 20% fructose + methionine induced changes in glucose and lipid levels, blood pressure, liver function markers and endothelial dysfunction in dose dependent manner. It also improved glucose tolerance pattern and antioxidant enzyme levels. Garcinia indica treatment is found to be comparable with combination of lisinopril, atorvastation and metformin treatment for treating cardio-metabolic syndrome. Conclusion: Feeding 20% fructose + methionine to normal rats for 45 days led to insulin resistance, hyperglycemia, dyslipidemia, hypertension and oxidative stress. Garcinia Indica combats all these abnormalities and can be used as an alternative for current therapies.

Keywords: Dyslipidemia, fructose, Garcinia Indica, insulin resistance, methionine


  MANJEET SINGH PRIZE – 5: Swiss Albino Mice Resistant to Double Stranded RNA Induced Inflammation of Small Intestine  Top


Singh Rahul, Medhi Bikash1, Kochhar Rakesh, Prasad Kaushal

Departments of Gastroenterology and 1Pharmacology, PGIMER, Chandigarh, India

Objectives: Lifelong gluten free diet is the only therapy for celiac disease (CD) which is difficult to comply. To optimize the alternative non-dietary therapies, appropriate animal models are required which can be used to further evaluate the chemical entities as a suitable drug therapy in a disease condition. In a path to develop an experimental animal model which can be a good assay system to evaluate new drug therapies, the current study evaluated Swiss albino mice and C57BL/6J mice. Methods: Polyinosinic-Polycytidylic Acid, a synthetic analogue of double stranded RNA was standardised and used to induce small intestinal injury which mimic characteristics of celiac disease of human counterpart. Results: All the doses of Polyinosinic-Polycytidylic acid used i.e. 20, 30, 40 mg/kg produced small bowel inflammation in C57BL/6J mice but failed to produce any significant changes in Swiss albino. Conclusion: Swiss albino strain is resistant to double stranded RNA induced small intestinal injury, thus this model is not suitable to evaluate drug therapy for celiac disease under in vivo condition.

Keywords: Animal, celiac disease, gluten enteropathy, models


  OD GULATI PRIZE – 1: Evaluation of Cardio Protective Effect of Cow Urine Ark on Isoprenaline Induced Myocardial Injury in Wistar Albino Rats and Ischemia Reperfusion Injury in New Zealand White Rabbits Top


Arunkumar D. Rana, Bhargav M. Purohit, Geeta B. Kharadi, Vishal K. Vadgama, Alpeshpuri P. Goswami1, Narendra K. Paliwal, C. B. Tripathi

Departments of Pharmacology and 1Pathology, Government Medical College, Bhavnagar. Gujarat, India

Objectives: To investigate the Cardio protective effect of the Cow urine ark on Isoprenaline Induced Myocardial Ischemia in Wistar albino rats and Ischemia Reperfusion Injury in New Zealand White rabbits. Methods: Acute toxicity study was done. Total phenolic and flavonoid content of Cow urine ark (CUA) was determined. In-vivo study groups: 72 Wistar albino rats were randomized into 6 groups. Rats were orally given Low dose (1.4 ml/kg) and High dose (2.8 ml/kg) CUA for 28 days and myocardial injury was produced by subcutaneous injection of isoprenaline (85 mg/kg) on day 27 and 28. Carvedilol (1 mg/kg) for 28 days served as active control. ECG, cardiac injury and Antioxidant markers and histopathological changes were seen. In-vitro study groups: Langendorff's isolated rabbit heart perfusion apparatus was used. Rabbits hearts were perfused with 2% & 4% CUA v/v. Force of contraction, heart rate, cardiac injury markers and histopathological changes were seen. Results: There was a dose dependent decreased in Troponin-I levels in both Low and High dose CUA group as compared to Isoprenaline control group. In CUA only group LDH, CK-MB and S. Uric acid were elevated suggestive of extra-cardiac lesion. Conclusion: In Low and High dose CUA group there was dose dependent decrease in Troponin-I level which did not reach statistical significance. So further evaluation can be planned with higher doses of CUA while keeping in mind the possibility of some extra cardiac lesion.

Keywords: Cardio protective, carvedilol, cow urine ark, isoprenaline, myocardial injury


  OD Gulati Prize Top



  OD GULATI PRIZE – 2: A Study of Scoring of Cardiovascular Risk in Hypertensive Post- Menopausal Women Top


Ritika Singla, Anita Gupta, Vijay K Sehgal, Harcharan Singh1

Department of Pharmacology, Government Medical College, 1Department of Cardiology, Rajindra Hospital, Government Medical College, Patiala, Punjab, India

Aims and Objectives: The aim and objective of the present study was to Evaluate the 10 year cardiovascular risk in post- menopausal women (PMW). Materials and Methods: This was an observational and cross-sectional prospective study conducted on the hypertensive PMW attending the Cardiology Outpatient Department of Rajindra Hospital. The patients fulfilling the inclusion and exclusion criteria were included in this study. The cardiovascular risk for next 10 years was calculated using online Framingham risk score calculator for women. Results: The study population comprised of 100 PMW with mean age of 60.09 years and mean age at menopause 47.27 years. Apart from hypertension, other CAD risk factors most commonly seen associated were obesity (26%) and diabetes (24%). The cardiovascular risk was greater by <5% from the optimal risk in 18% of the patients and greater by >30% from the optimal risk in 6%. In the former group, mean duration since menopause was 9.54 years and mean SBP was 118 mm Hg and in the latter group, mean duration since menopause was 18.4 years and mean SBP was 174 mm Hg. The most common risk factor associated was uncontrolled hypertension (50%) followed by obesity (26%) and diabetes (24%). Conclusions: Our study suggests that the time since menopause significantly increases cardiovascular risk in hypertensive PMW. Hypertension was poorly managed in nearly half of the study population. Also uncontrolled hypertension has a major bearing on cardiovascular risk followed by other risk factors like obesity and diabetes.

Keywords: Cardiovascular risk, hypertension, postmenopausal women


  OD GULATI PRIZE – 3: Knowledge and Practice of Lifestyle Modification in the Management of Hypertension among South Indian Hypertensive Population Attending a Tertiary Health Care Top


Farhana R, Inbaraj SD, Kumaramanikavel G1,

Muthiah NS2

Department of Pharmacology, Genomic Lab, Sree Balaji Medical College and Hospital, 1Genomic Lab, Sree Balaji Medical College and Hospital, 2Department of Pharmacology, Sree Balaji Medical College and Hospital, Bharath University, Chennai, Tamil Nadu, India

Objective: To assess the level of awareness and practice of lifestyle modification among hypertensive adults in south Indian population visiting a tertiary health care centre in Chennai. Methods: A cross sectional study was done involving adult hypertensive patients (25-85 years) who came to hospital for treatment. Patients who had an initial blood pressure of ≥140/90 mm of Hg and under anti-hypertensive treatment were taken for study. A standard questionnaire was used for data collection. Results: A total of 200 individuals were recruited including both male and female. 88% of patients has the knowledge of high blood pressure and its complications. In lifestyle practise modification, 80% patient usually take salt restricted diet, 60% takes low fat dairy products, 70% takes citrus fruits, 80% takes fish and lean meat, 70% avoided fatty and oily food, 20% do exercises regularly. Unable to do regular physical exercises is due to lack of family support in 30% of patients and hectic office schedules in 70% of patients. Conclusions: Awareness regarding high blood and its complication is good but practice of lifestyle modification among the hypertensive patients needs more motivation and supports from family members.

Keywords: Cardiovascular risk, hypertension, postmenopausal women


  OD GULATI PRIZE – 4: Telmisartan and Esculetin Combination Ameliorates Type 2 Diabetic Cardiomyopathy by Reversal of H3, H2a and H2b Histone Modifications Top


Anil Bhanudas Gaikwad, Almesh Kadakol, Vajir Malek, Santosh Kumar Goru, Anuradha Pandey

Department of Pharmacy, Laboratory of Molecular Pharmacology, Birla Institute of Technology and Science, Pilani, Rajasthan, India

Objectives: Though cardio-protective effects of telmisartan are well explored, its effects on epigenetic alterations associated with type 2 diabetic (T2D) cardiomyopathy remain unmapped. Thus, the present study was designed to evaluate the potential of esculetin and telmisartan combination to reverse histone posttranslational modification (PTMs) in curbing T2D cardiomyopathy. Methods: T2D was induced by high fat diet feeding along with low dose of streptozotocin (35mg/kg, I.P) in male Wistar rats. T2D rats were treated with either telmisartan (10 mg/kg/day, P.O) or esculetin (50 mg/kg/day doses, P.O) or their combination for two weeks. Biochemical estimations, vascular reactivity, immunohistochemistry and western blotting experiments were performed to evaluate the effects of the treatment in T2D cardiomyopathy. Results: Esculetin and telmisartan combination alleviated the pathological features of T2D cardiomyopathy including metabolic perturbations, morphometric alterations, altered vascular reactivity, increased Keap1 and fibronectin expression more effectively than their respective monotherapy. This is the first report showing that telmisartan attenuates increased level of histone PTMs like H3K9me2, H3K9Ac, H2AK119Ub and H2BK120Ub in heart of T2D rats. The combination regimen showed a more significant reduction in augmented histone PTMs associated with T2D cardiomyopathy than their independent treatments. Conclusions: The present study demonstrates that esculetin and telmisartan combination can be an advanced pharmacological approach to ameliorate T2D cardiomyopathy which could be partially attributed to its ability to reverse the epigenetic alterations.

Keywords: Epigenetics, Esculetin, Telmisartan, type 2 diabetic cardiomyopathy


  OD GULATI PRIZE – 5: Apigenin Ameliorates Myocardial Infarction in Diabetic Rats via PPAR-γ Signaling Pathway Top


Umesh B Mahajan, Govind Chandrayan, Chandragouda R Patil, Sameer N. Goyal

Department of Pharmacology, R. C. Patel Institute of Pharmaceutical Education and Research, Shirpur, Maharashtra, India

We investigated the effect of apigenin on myocardial infarcted diabetic rats via modulation of the PPAR-γ pathway. Diabetes was induced by administration of single dose of streptozotocin (55 mg/kg i.p). Diabetic rats received either apigenin or PPAR-γ antagonist (GW9662) or in combination for 14 days with simultaneous direction of isoproterenol (100 mg/kg s.c) on 13th and 14th day. Isoproterenol provoked cardiotoxicity was confirmed by reduction systolic, diastolic and mean arterial pressures as well as maximal positive rate of developed left ventricular pressure, maximal negative rate of developed left ventricular pressure besides an increase in left ventricular end-diastolic pressure along with oxidative stress. Myocardial infarcted diabetic rats exhibited increased myonecrosis, edema, and apoptotic cell death. Treatment with apigenin meaningfully enhanced the redox status of the myocardium. Apigenin evidently reserved arterial pressures as well Bax expression, TUNEL-positive cells, and myonecrosis. On the other hand, administration of apigenin and GW9662 did not extend the same effects, when administered concurrently or independently. Furthermore, the rats treated with apigenin showed increased expression of PPAR-γ. Hence, the present study confirms the protective effects of apigenin on myocardial infarcted diabetic rats via modulation of PPAR-γ pathway.

Keywords: Apigenin, diabetic cardiac complications, isoproterenol, myocardial infarction, PPAR-γ, streptozotocin


  OD GULATI PRIZE – 6: Agmatine Attenuates Atypical Antipsychotic Induced Obesity and Metabolic Disturbances in Rats Top


Madhura Dixit, Manish Aglawe, Mayur Kale, Dinesh Gawande, Brijesh G Taksande, Nandkishor R Kotagale

Department of Pharmacology, Division of Neuroscience, Shrimati Kishoritai Bhoyar, College of Pharmacy, Nagpur, Maharashtra, India

Objective: The present study was planned to investigate the role of agmatine in olanzepine induced body weight gain and metabolic dysfunction in rats. Materials and Methods: After 14 days of olanzepine (1 mg/kg, i.p.) administration, rats were subdivided into four groups, each consisting of six rats: a control group [(Olanzepine (1 mg/kg, i.p.) with saline] and three groups with olanzepine (1 mg/kg, i.p. daily) plus different dosages of agmatine (5- 20 mg/kg, i.p. once daily). Agmatine treatment was given for next 7 days daily. The cumulative food intake (g) and body weights were measured daily before drug or saline administration. At the end of the experimental period, blood was withdrawn and subjected to analysis of triglyceride (TG), total cholesterol (TC), low-density lipoprotein, high-density lipoprotein cholesterol (HDL-C) levels. After blood withdrawal, rats were sacrificed and white adipose tissues (WAT) were carefully excised from epididymal, perirenal and retroperitoneal locations and rinsed with phosphate buffer saline and weighed. Results: Repeated olanzapine (1 mg/kg) once daily for 21 days although did not influence food intake, produced a significant increase in body weight and elevation of TG, TC, LDL-C, total white adipose tissues weights and decreased HDL-C. Agmatine (10 and 20 mg/kg, i.p.) attenuated the weight promoting effect of olanzapine, restored white adipose tissue mass and improved lipid profile in olanzepine treated rats. Conclusion: Given that agmatine itself possessed antipsychotic like effect in animal models of schizophrenia, it may offer novel therapeutic strategies in reducing olanzepine induced body weight gain while preserving its therapeutic efficacy.


  OD GULATI PRIZE – 7: Drug Utilization Pattern of Anti-Diabetic Drugs and their Commonly Encountered Adverse Drug Reactions in a Tertiary Care Hospital - An Observational Study Top


Subhadeep Patra, Vartika Srivastava, Jotirmoyee Jena

Department of Pharmacology, KIMS, Bhubaneswar, Odisha, India

Context: Diabetes mellitus (DM) is a group of metabolic diseases characterized by hyperglycaemia resulting from defects in insulin secretion, insulin action, or both. According to World Health Organization, drug utilization is defined as the marketing, distribution, prescription and use of drugs in a society with special emphasis on the resulting medical, social and economic consequences. An adverse drug reaction (ADR) is defined by World Health Organization (WHO) as any response to a drug which is noxious, unintended and occurs at doses used in man for prophylaxis, diagnosis or therapy. Aims: To analyse the current prescribing pattern in patients of type 2 diabetes mellitus with regard to drug/drugs prescription, dose, duration of treatment and ADRs associated with the drugs. Settings and Design: This is a prospective, parallel group, comparative observational study conducted in collaboration with department of Endocrinology KIMS, Bhubaneswar. The study was approved by the Institutional Ethical committee, KIMS, BBSR. Materials and Methods: a total of 220 patients were enrolled in the study and further divided into two categories Pre obese:n (a) New diabetic (n=52) (b) Old diabetic (n=160) Obese:(a) New diabetic (n=12) (b) Old diabetic (n=40) All the patients were on antidiabetic medications along with medications for other co morbid condition Statistical Analysis Used: All values were expressed as means ± SD. Statics applied is unpaired t test and paired t test. Results: Most of the drugs were prescribed by their proprietary names. Metformin was the most commonly prescribed medication either given as monotherapy or combination therapy. Amongst dual therapy, Metformin+ Glimepiride combination was the most preferred choice, followed by Metformin+Voglibose combination. Considering triple therapy, Metformin+Glimepiride+Voglibose was the most commonly prescribed combination followed by Sitagliptin regimen. Insulin was just prescribed to those patients having high HbA1C levels >9%, uncontrolled even after triple regimen. In case of ADR, nausea and vomiting was the most common complains of the patients, followed by abdominal discomfort. Sulfonylureas and Gliptins were found to cause hypoglycaemia and weight gain respectively. Conclusions: The pharmacotherapy for type 2 DM prescribed in this tertiary care hospital was found to be compliant with ADA guidelines, National Treatment Standard Guidelines and Step care approach recommended by WHO. Severity of the ADRs were less and manageable by the physician.

Keywords: Adverse drug reaction, antidiabetic drugs, diabetes mellitus, drug utilization pattern

[TAG:2]OD GULATI PRIZE – 8: Involvement of Hedgehog Pathway in Preconditioning of Estrogen Deficient Ischemic Reperfused Heart [/TAG:2]

Sharma Shweta, Sharma Saurabh

Department of Pharmacology, Cardiovascular Division, I.S.F College of Pharmacy, Moga, Punjab, India

Objective: The present study was designed to investigate the myocardial preconditioning potential of hedgehog pathway against ischemia/reperfusion injury in estrogen deficient rats. Methods: Female wistar rats underwent bilateral ovariectomy and subjected to Ischemia/Reperfusion protocol after 28 days. The heart was isolated and mounted on Langendorff's apparatus, subjected to 30 min of ischemia followed by 120 min of reperfusion. Ischemic Preconditioning (IPC) was mediated by four cycles of 5 min ischemia and 5 min reperfusion. Myocardial injury was assessed in terms of increase in infarct size, LDH, CK-MB, TBARS and MPO level of the isolated perfused rat heart. TNF-α level was measured by ELISA kit, eNOS expression was estimated by rt-PCR. Results: Preconditioning with estradiol (280nM) and hedgehog agonist purmorphamine (1μM) showed the cardioprotective effect against ischemia/reperfusion injury and restored attenuated cardioprotective potential of ischemic preconditioning phenomenon in ovariectomized rat hearts. GDC-0449 blocked the protective effect of IPC in normal rat heart and estradiol-mediated preconditioning in ovariectomized rat heart. Conclusion: Therefore, it can be concluded that hedgehog pathway has a pivotal role in estrogen-mediated cardioprotection and stimulation of hedgehog pathway has preconditioning potential against ischemia/reperfusion in estrogen deficient myocardium.

Keywords: GDC-0449, hedgehog, ischemic preconditioning, ischemic reperfusion injury, ovariectomy, purmorphamine


  GUFIC Prize Top



  GUFIC PRIZE – 1: Effect of Alcoholic Extract of Adhatoda vasica L. Leaves and Allium cepa l. Bulb in Diabetic Wound Healing in Wistar Albino Rats Top


Patel NS, Naik VN, Hirapara HN1, Acharya HR, Baxi SN2, Tripathi CB

Departments of Pharmacology and 2Pathology, Government Medical College, Bhavnagar,1Department of Pharmacology, GMERS Medical College, Junagadh, Gujarat, India

Objective: To evaluate the effect of Alcoholic Extract of Adhatoda Vasica L. Leaves (AV) and Allium Cepa L. Bulb (AC) in Diabetic Wound Healing in Wistar Albino Rats. Methods: 48 Wistar albino rats (weight - 250 ± 50 gm) of either sex were randomly divided into 8 groups. Group 1-4, Excision wound model (received drug orally till complete healing); Group 5-8, Incision & Dead space model (received drug orally for 11 days). Group 1: Distilled water. Group 2: Glibenclamide 0.5mg/kg Group 3: AV 400 mg/kg. Group 4: AC 300 mg/kg Group 5: Distilled water. Group 6: Glibenclamide 0.5mg/kg. Group 7: AV 400 mg/kg. Group 8: AC 300 mg/kg. Percentage wound closure and re-epithelization measured in excision wound model. Tissue breaking strength measured in incision wound model. Dry weight granuloma, hydroxyproline estimation and histopathology examination was done in dead space wound model. Results: Significant improvement in wound closure on day 3, 7 and 11, re-epithelization on day 11, tissue breaking strength, dry weight granuloma and hydroxyproline content was seen in AV group. Significant improvement in wound closure on day 11, re-epithelization on day 11, tissue breaking strength, dry weight granuloma and hydroxyproline content was seen in AC group. In histopathology, fibroblast formation higher in adhatoda vasica group and fibroblast formation, neoangiogenesis increased in allium cepa group but not achieved statistically significant level. Conclusion: Alcoholic extract of Adhatoda vasica L. and Allium cepa L. improves wound contraction, reepithelization, granulation tissue and collagen formation.

Keywords: Adhatoda Vasica L., Allium Cepa L., diabetes mellitus, re-epithelization, streptozotocin


  GUFIC PRIZE – 2: Effect of Pedalium murex Seed Extract on Testicular Dysfunction in Streptozocin Induced Diabetic Mellitus in Wistar Albino Rats Top


Panigrahy Ankita, Behera JP, Maharana CS

Department of Pharmacology, MKCG Medical College, Berhampur, Odisha, India

E-mail: [email protected]

Objective: Diabetes mellitus is associated with severe functional complications. Patients have alterations in sexual functions i.e decrease in libido, fertility. Pedalium murex, a herb found in India is known to possess hypoglycemic,antioxidant, aphrodisiac properties. This study evaluates effect of petroleum ether extracts of P.murex (PEPM) on testicular dysfunction by estimating fasting blood glucose,oxidative stress markers and seminal analysis in streptozotocin induced diabetes mellitus. Methods: In 30 male wistar albino rats diabetes was induced by single dose injection(i.p) of streptozotocin(55mg/kg).They were divided into 5 groups(n=6). Group1:Control,Group2:Disease Control,Group3- metformin (50 mg/kg), Group 4-PEPM(400 mg/kg) & Group 5-(PEPM)+ metformin (25mg/kg). Drugs were given for 60 days. On day 61, FBG was estimated, animals were sacrificed, semen collected from caudal epididymis. Sperm count, motility, morphological abnormalities were noted by microscopic examination. Testicular tissue homogenate was prepared,oxidative stress markers- MDA and SOD were estimated. Results: In comparison to the normal, Diabetic control group showed significant difference (p value<0.05) in fasting blood glucose, sperm count, motility,MDA & SOD levels. Similarly compared to diabetic control, rats treated with PEPM (400 mg/kg) and combination of PEPM+ metformin showed significant difference (p value <0.01) in the above parameter with restoration of normal sperm morphology. The effect of PEPM was found to be similar to metformin for most of the parameters. Conclusion: Naturally derived active principles(phytochemicals) from P.murex possess anti-hyperglycemic, germ-cell protective and antioxidant properties. Studies to test their role in treatment of diabetes induced male and female reproductive impairment can throw further light in this area and help us in combating this global problem.

Keywords: Diabetes mellitus, Pedalium murex, testicular dysfunction


  GUFIC PRIZE – 3: Evaluation of Immunomodulatory Activity of Gymnema Sylvestre in Albino Rats Top


Kar Padmaja Priyadarshini, Rath B, Roja Ramani Y, Panigrahi A, Panigrahi P, Maharana CS

Department of Pharmacology, MKCG Medical College, Berhampur, Odisha, India

E-mail: [email protected]

Aims and Objective: To evaluate the immunomodulatory activity using hydro-alcoholic extract of Gymnema sylvestre leaves in Wistar albino rats. The immunomodulatory properties were studied using three models; Sheep RBC challenged change in foot pad thickness, neutrophil adhesion test and humoral antibody response to measure delayed hypersensitivity, cellular immunity and humoural immunity respectively. Six groups of rats (n=6 in each gr.) were treated with drugs and vehicle for 14 days orally. Gr. I served as control. Gr. II was given with CP (100mk/ki ip). Gr, III, IV and Gr. V were administered with Levamisole, GSE 200 and GSE 400 mg/kg. Only GSE 400mg/kg was given to Gr. VI rats. Sheep RBC was used for antigen sensitization and subsequent challenge. CP was injected to rats of gr III, IV and V on 12th day of drug treatment. On 14th day the change in foot pad thickness, % neutrophil adhesion and hemagglutination titre was noted. Results: From the present study, Gymnema sylvestre extract 200 and 400mg/kg increased Delayed hypersensitivity reaction, % neutrophil adhesion and haemagglutination titre in CP treated rats to a significant extent as compared to Cyclophosphamide control group.(p<0.05). Conclusion: The hydro-alcoholic extract of Gymnema has immunostimulatory effects on both humoral and cell mediated immunity.


  GUFIC PRIZE – 4: Effect of Ethanolic Extract of Bark of Crataeva nurvula, on Thyroid Status, Cholesterol, Oxidative Stress and Physiological Parameters, in Female Adult Mice Top


Arshvir Kaur, Santosh Kumar Verma, Shaina Kalsi, Neha

CT Institute of Pharmaceutical Sciences, CT Institute, Jalandhar, Punjab, India

Objectives: The ethanolic extract of Crataeva nurvula (CNet) bark, was evaluated for its effect on Free thyroxine (FT4), Thyroxine (T4), Thyroid Stimulating Hormone (TSH) and thyroid gland weight (TW); serum cholesterol (CHO); Lipid peroxidation (TBARS) and reduced glutathione (GSH); Body weight (BW), food consumption (FC) and water intake (WI) in mice. Methods: Healthy Swiss albino female adult mice of 28-33 g were divided into three groups i.e. Group I, Vehicle treated, Group II & III, administered with CNet 400 mg/Kg BW and CNet 600 mg/Kg BW for 15 days, per os (p.o.). The variation in the T4, FT4, TSH and CHO was recorded on Day 0th and Day 15th individually, whereas the average values of FC, BW and WI were taken of two weeks. TBARS, GSH and TW were analysed at the end of study via intercomparison of all groups. Results: Vehicle treated group showed no marked variation. CNet 400 had significantly raised the T4, FT4, TBARS, FC and WI, with noticeable decline in TSH, CHO and significantly reducing GSH levels. CNet 600, insignificantly raised T4, TSH but CHO to significant level, yet being safe on oxidative profile. Both CNet 400 & 600 have shown insignificant rise in thyroid weight and negligible changes in BW. Conclusions: CNet 400, showed stimulatory effects on thyroid parameters, suggesting its role in treating hypothyroidism, whereas CNet 600 showed slight but skeptical changes. It inhibited thyroid function through negative feedback action or leading to thyroid hormone resistance at higher, thus depicting, the narrow therapeutic index of C. nurvula.

Keywords: Cholesterol, Crataeva nurvula, thyroid gland, thyroid stimulating hormone, thyroxine


  GUFIC PRIZE – 5: Evalution of In vitro and In vivo Thrombolytic Activity of Andrographis paniculata and Arbutus unedo Top


Piyush Kashyap, Dhaval Patel, Rohit Sane1, Rahul Mandole1, Mukesh Nandave

SPP School of Pharmacy and Technology Management, SVKM's NMIMS University, 1Madhavbaug Multidisciplinary Cardiac Clinics and Hospitals, Mumbai, Maharastra, India

E-mail: [email protected]

Objective: The present study aimed to investigate in-vitro and in vivo thrombolytic activity of Andrographispaniculata (APE) and Arbutus unedo (AUE) extracts. Methods: Thrombolytic activity of hydroalcoholic extracts of APE and AUE was evaluated against thrombin-, collagen-, arachidonic acid-, ADP-, and epinephrine-mediated platelet aggregation and clot lysis method at different doses. Then APE (100 & 200 mg/kg) and AUE (20 & 40 mg/kg) were evaluated for thrombolytic activity in FeCl3-induced thrombosis model in rats. Results: APE was able to inhibit platelet aggregation by 58% at 50 μg/mL and 100% at 100 μg/mL whereas AUE by 83% at 100 μg/mL only in thrombin-induced platelet aggregation. Further, APE lysed 45% of the formed clot while AUE lysed 35% of formed clot. Both, APE and AUE showed dose dependent antithrombolytic activity as evidenced by significant reduction size and weight of thrombus in FeCl3-induced thrombosis model. Conclusion: APE and AUE remarkably attenuated plate aggregation, clot formation invitro along with reduction in thrombus formation in vivo which confirms their thrombolytic activity. Obtained thrombolytic activity with APE and AUE could be attributed to the flavonoids and total phenols present in both the plants.

Keywords: Clot lysis, platelet aggregation, thrombolytic activity, thrombus


  GUFIC PRIZE – 6: Evaluation of the Effect of Indian Medicinal Plants in a Murine Model of Dextran Sulfate Sodium (DSS) Induced Acute Colitis Top


Kritarth Naman Mithileshwar Singh, Sandhya Kaustubh Kamat

Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Mumbai, Maharastra, India

Objective: The objective of this study was to investigate the effect of Aegle marmelos (AM) and Punica granatum (PG) individually and in combination regimens in an experimental model of dextran sulfate sodium (DSS)-induced colitis. Materials and Methods: The study was done in two phases. In phase I, 36 Swiss albino mice were divided (n=6/group) to receive: vehicle, sulfasalazine-100 mg/kg, AM-0.39g/kg/day, AM-0.78g/kg/day, PG-5.20g/kg/day and PG-10.40g/kg/day. In phase II 30 mice were divided into five groups (n=6/group) and treated with vehicle, sulfasalazine-100 mg/kg, AM-0.78g/kg/day + PG-10.40g/kg/day, AM -0.78g/kg/day + sulfasalazine-50mg/kg and PG-10.40g/kg/day + sulfasalazine-50mg/kg. Animals received test drugs from day 1-7 followed by the test drugs along with the inducing agent from day 8–14. The variables assessed were disease activity index, colon length, colon weight-by-length ratio, colitis macroscopy and colon histopathology using “Swiss-roll” technique. Results: As compared to vehicle, the high dose AM group showed significantly effective results on all the variables (p<0.05). In the high dose PG group only colon weight-by-length ratio was significantly different from the vehicle. AM+PG (high dose combination) and AM+sulfasalazine-50mg/kg combination was significantly different from the vehicle for all variables. (p<0.05) Conclusion: The higher doses of AM and PG showed alleviation of DSS-induced colitis, both individually and in combination. The high dose AM+sulfasalazine-50mg/kg combination also caused a significant decrease in colitis.

Keywords: Aegle marmelos, Punica granatum, ulcerative colitis


  GUFIC PRIZE – 7: A Study of Glycyrrhiza Glabra on Experimentally Induced Psychosis in Rats Top


Disha Shukla, Kirti Patel1, Rajesh A Maheshwari, R Balaraman

Department of Pharmacy, SumandeepVidyapeeth, 1Faculty of Pharmacy, The M. S. University of Baroda, Vadodara, Gujarat, India

E-mail: [email protected]

Objective: To evaluate the antipsychotic effect of aqueous liquorice extract (ALE) on dopamine induced psychosis. Methods: MTT assay was conducted on SHSY5Y cell lines to test the treatment to effective as a neuroprotective. Effect of aqueous liquorice extract (ALE) was evaluated on dopamine (40μg/ml i.c.v.) induced psychosis. ALE (250 mg/kg and 500mg/kg p.o.) was administered daily for 14 days. Dopamine was administered by i.c.v route for the last three consecutive days of the 14 day study in female Sprague dawley rats. During the study behavioral parameters i.e. forced swim test, rotarod test, Cooke's pole test and locomotor activity, were assessed on day 1, 13, 14, and 15. After the completion of the study, biochemical (DAO activity, AchE inhibition and nitrite) and neurochemical estimations (dopamine, 5-HT, NE, glycine, glutamate, GABA) in the rat brain homogenates were conducted. Results: ALE at both doses (250mg/kg and 500mg//kg p.o.) showed a significant inhibition of the dopamine induced behavioral abnormalities and also improved dopamine induced neurotransmitter imbalances when compared with the positive control animals. An altered redox state in animals was seen with the increase of nitrite levels on i.c.v. administration of dopamine along with the increase of DAO and AchE activity. On the contrary, when psychosis induced animals were treated with ALE, there was a remarkable decrease in nitrite level confirming its antioxidant property and was shown to inhibit the DAO and AchE enzyme. Conclusion: ALE showed to be neuroprotective along with the correction of behavioral dysfunctions and neurochemical imbalances induced by dopamine.

Keywords: Aqueous liquorice extract, DAO, Dopamine, MTT assay, neurochemical estimation, SD rats


  GUFIC PRIZE – 8: Embelin Modulates Central Neurotransmitters and Attenuates Streptozotocin Induced Cognitive Impairment and Biochemical Abnormalities in Rats Top


Rimpi, Rahul Deshmukh

Neuropharmacology Division, I. S. F. College of Pharmacy, Moga, Punjab, India

Objective: The present study was design to investigate neuroprotective mechanisms and therapeutic potential of embelin against intracerebroventricular streptozotocin (ICV-STZ) induced experimental sporadic dementia in rats. Materials and Methods: STZ was infused bilaterally at the dose of 3 mg/kg/icv on day 1st and 3rd after surgery. Rats were treated with embelin (2.5, 5 and 10 mg/kg i.p.) for 14 days from 7th day onwards after ICV-STZ. Spatial and non-spatial memory was evaluated using Morris water maze and objectrecognition task in rats. On day 22 rats were sacrificed and hipoocampal brain regions were used to identify biochemical, neurochemical and neuroinflammatory alterations. Results: STZ infused rats showed significant learning and memory deficit which was associated with increase in oxidative stress (lipid peroxidation and nitrite), compromised antioxidant defense (reduced glutathione), neurotransmitter alteration (AChE, dopamine, noradrenaline, 5- hydoxytryptamine, Gama amino butyric acid and glutamate) and elevation in neuroinflammatory cytokine (IL-1 β, IL-6 and TNF- α) levels. Embelin dose dependently attenuated STZ-induced cognitive deficit and biochemical alterations and restored neurochemical levels. Conclusions: The observed protective effect might be attributed to the antioxidant and anti-inflammatory potential of embelin and its ability to restore the levels of cortical and hippocampal neurotransmitters. The outcomes of the current study suggest therapeutic potential of embelin in cognitive disorders such as AD.

Keywords: Embelin, ICV-STZ, oxidative stress, anti-inflammation, cognitive dysfunction.


  GUFIC PRIZE – 9: Portulaca oleracea Extract Provides Cardioprotection in Isoproterenol-Induced Model of Myocardial Infarction in Rats Top


Mamta Venna, Mrinal Sanaye, Mukesh Nandave1

Prin. K.M.Kundnani College of Pharmacy, 1SPP School of Pharmacy and Technology Management, SVKM's NMIMS University, Mumbai, Maharashtra, India

Objective: Owing to potent antioxidant, anti-inflammatory, diuretic and hypolipidemic activity of Portulaca oleracea (PO), we intended to evaluate its cardioprotective effect of its different extracts in isoproterenol (ISO)-induced model of myocardial infarction (MI) in rats. Methods: In ethanol, n-hexane and petroleum ether extracts of PO, linoleic acid was quantified by HPTLC and their antioxidant activity was measured in in vitro assays. Adult SD rats of either sex (180-200g) treated with ethanolic PO extract (200 and 400mg/kg p.o.) for 21 days followed with ISO injection on 20th and 21st day at doses 52.5 and 85 mg/kg s.c., respectively. After 24 hrs of last dose of ISO, haemodynamic parameters and ECG were recorded in all animals. Serum levels of (CKMB, LDH-P, SGOT, SGPT, TP, TG, TC and Uric acid) and tissue (CAT, SOD, LPO, GSH, GR, GPx) were measured followed by histopathology of heart. Results: Among all three extracts, ethanolic extract was found to contain significant amount of linoleic acid. ISO induced elevated levels of CKMB, SGOT, TG and Uric acid were found to be reduced significantly in treatment groups. Extract was also found to prevent decrease in CAT, GSH, GR and GPx and increase in LPO in tissue significantly. PO treatment maintained the integrity of myocardial tissue despite of ISO insult. Such biochemical and architectural protection could be responsible for PO mediated correction of haemodynamic and ECG parameters. Conclusion: In the present study, PO provided cardioprotection against ISO-induced myocardial damage which could be attributed to presence of linoleic acid, an established cardioprotective polyunsaturated omega-6 fatty acid.

Keywords: Common purslane, isoproterenol, linoleic acid, Portulaca oleracea


  GUFIC PRIZE – 10: Macrophage Inhibitory and Anti-Apoptotic Effects of Cissus quadrangularis by Modulating Pro-/Anti-Inflammatory Cytokines Secretion and P53, BAX, BCL-2, Cytochrome C and Caspase-3 Proteins Top


Rohit Kumar, Surender Singh, Yogendra Kumar Gupta

Department of Pharmacology, All India Institute of Medical Sciences, New Delhi, India

Objective: Cissus quadrangularis is a traditional medicinal plant used in the treatment of various inflammatory and immunological disorders. The present study was carried out to investigate the anti-inflammatory and anti-apoptotic potential of Cissus quadrangularis hydroalcoholic extract (CQHE). Materials and Methods: CQHE was administered orally at doses of 50-200mg/kg body weight/day. Anti-inflammatory activity of CQHE was evaluated using carrageenan-induced paw edema, cotton pellet implantation and complete Freund's adjuvant-induced stimulation of peritoneal macrophages models respectively. Anti-apoptotic activity was evaluated in LPS stimulated RAW 264.7 macrophage like cells. Results: Oral administration of CQHE produced dose dependent reduction in carrageenan-induced paw edema and cotton pellet-induced granuloma model. CQHE treatment significantly decreased expression of pro-inflammatory cytokines/mediators, including TNF-α, IL-1β, IL-6, TNF-R1, and COX-2, along with an increase in anti-inflammatory cytokine IL-10 in serum and activated peritoneal macrophages suggesting that CQHE have anti-inflammatory potential. CQHE treatment in LPS stimulated RAW 264.7 cells inhibited apoptosis by inhibiting p53 accumulation, cytochrome-3, caspase 3 activation and by decreasing Bax/Bcl-2 ratio. As excess NO production by iNOS is responsible in inflammation and apoptosis associated disorders, therefore levels of NO and iNOS were evaluated and was found to be attenuated with CQHE. Conclusion: Result of the present study demonstrates the anti-inflammatory and anti-apoptotic potential of Cissus quadrangularis.

Keywords: Apoptosis, Cissus quadrangularis, inflammation, macrophages, pro-inflammatory cytokines


  GUFIC PRIZE – 11: Non Drug Intervention, a Potential Therapeutic Option for Treatment of Type 2 Diabetes Top


Balakumar Mahalingam

Central Drugs Standard Control Organization, DGHS, Ministry of Health and Family Welfare, New Delhi, India

E-mail: [email protected]

Diabetes is one of the most challenging health problems of the 21st century in worldwide. According to the latest report from International Diabetes Federation (IDF) diabetes  Atlas More Details 7th edition, the global prevalence is estimated about 415 million people living with diabetes (DM) and 318 million people with impaired glucose tolerance (IGT) who have higher possibility to develop diabetes. Government has been initiated various steps to control prevalence of diabetes in India. Drugs from various therapeutic drug targets is available in the county still management of type to diabetes is remain challenge. Hence, functional foods and yoga/naturopathy is one of the additional therapeutic option which may control diabetes effectively with more cost effective manner. Traditional foods (functional foods) like Whole Grains, Phytochemical-Rich fruits and Vegetables, Legumes, and Probiotics food supplements were contains number of bioactive molecules which acts various pathways and ameliorates hyperglycemia, β cell degeneration, pro-inflammatory mediators and glucose utilization. It is also found that Yoga practice enhances the subjective wellbeing, quality of life, improves mood and concentration, and facilitates achievement of adequate glycemic control among Type II diabetic patients. These recent findings demonstrated that functional foods, Yoga and physical activity would be future prescription for adjunct therapy for management of diabetes and its complication without any major economic burden.

Keywords: Functional food, naturopathy, type 2 diabetes, yoga


  GUFIC PRIZE – 12: Anti-Fatigue, Anti-Stress and Adaptogenic Potential of Ganoderma lucidum Top


Rajkumar Tulsawani, Manimaran Manickam, Purva Sharma

Department of Biochemical Sciences, Defence Institute of Physiology and Allied Sciences, DRDO, Ministry of Defence, Government of India, Delhi, India

Objectives: To evaluate anti-fatigue, anti-stress and adaptogenic potential of Ganoderma lucidum . Materials and Methods: Mice were treated with aqueous extract of Ganoderma lucidum fruiting body for one week and forced swim test was conducted to measure exhaustion time as marker of anti-fatigue activity. In another experiments, mice were exposed to hypobaric hypoxia, anoxia stress (latency of convulsion recorded) and cold-restrain stress in the absence or presence of extract for studying its anti-stress and adaptogenic activity. After exposure period, serum was collected for measuring MDA, GSH, GPx, SOD levels, ALT, AST, glucose, triglyceride, cholesterol, NFκB, TNFα and IL6. Results: The treatment of experimental animals with aqueous extract of Ganoderma lucidum showed increase in exhaustion time in forced swim test compared to animals without extract treatment. Further, extract treatment increased latency of convulsions in anoxia stress test. In another study, mice exposed to hypobaric hypoxia in the presence of extract had better maintained antioxidant status (MDA, GSH, GPx and SOD) and prevented rise in pro-inflammatory markers (NFκB, TNFα and IL6). Moreover, mice exposed to cold-restrain stress in the presence of extract prevented changes in biochemical markers (MDA, GSH, GPx, SOD, ALT, AST, glucose, triglycerides, and cholesterol). Conclusions: The data obtained from the studies suggest that aqueous extract of Ganoderma lucidum fruiting body has anti-fatigue and anti-stress activity and adaptogenic potential.


  GUFIC PRIZE – 13: Neuroprotective Potential of Ethyl Acetate Fraction of Roots of Leea Indica Against MPTP-Induced Neurotoxicity in Rats Top


Priya Jaswal, Rahul Deshmukh

Neuropharmacology Division, I.S.F. College of Pharmacy, Moga-142001, Punjab, India

Objective: The present study was designed to investigate the therapeutic potential of ethyl acetate fraction of roots of Leea indica against MPTP-induced motor deficit, biochemical and neurochemical abnormalities in rats. Methods: MPTP (100μg/1μl) was administered intranigrally (bilaterally) repeatedly at three day interval (day 1, 4 & 7) to produce stable motor deficit. Leea indica ethyl acetate fraction (15, 30 and 60 mg/kg p.o.) was administered from day 1 to day 15. Motor abnormalities were assessed by narrow beam walk, rota-rod and grip strength. Striatal brain tissue homogenate was used to determine the levels of oxidative stress markers, pro-inflammatory cytokines (TNF-α, IL-1β and IL-6) and striatal dopamine levels. Results: MPTP infusion in rats produced stable motor-deficits and caused elevation in oxidative stress markers, cytokines levels and decline in striatal dopamine levels. Ethyl acetate fraction of Leea indica (LIEAF) showed potent phosphodiesterase (PDE) inhibitory activity and attenuated MPTP- induced behavioral and biochemical abnormalities in rats. LIEAF treatment precludes MPTP-induced oxidative stress, neuroinflammation and restored striatal dopamine levels. Conclusions: The observed improvement in motor functions in MPTP-infused rats following LIEAF may be due to its anti-oxidant, anti-inflammatory actions and its ability to restore striatal dopaminergic signaling.

Keywords: Cyclic nucleotides, Leea indica, MPTP, Parkinson's disease, PDE


  GUFIC PRIZE – 14: Influence of MDR1 & CYP3A5 Genetic Polymorphisms on Trough Levels and Therapeutic Response of Imatinib in Newly Diagnosed Patients with Chronic Myeloid Leukemia Top


Harivenkatesh Natarajan, Lalit Kumar1, Sameer Bakhshi1, Atul Sharma1, Madhulika Kabra2, Tirumurthy Velpandian, Ajay Gogia1, Shivaram S Shastri2, Yogendra Kumar Gupta

Departments of Pharmacology, 1Medical Oncology and 2Pediatrics (Genetics Unit), All India Institute of Medical Sciences, New Delhi, India

Objectives: Polymorphisms in genes coding for imatinib transporters and metabolizing enzymes may affect imatinib pharmacokinetics and clinical response. Aim of this study was to assess the influence of polymorphisms in MDR1 and CYP3A5 genes on imatinib trough levels, cytogenetic and molecular response in patients with chronic myeloid leukemia (CML). Methods: Newly diagnosed patients with chronic-phase CML started on imatinib therapy were enrolled and followed up prospectively for 24 months. The following single nucleotide polymorphisms were genotyped; C1236T, C3435T, G2677T/A in MDR1 gene and A6986G in CYP3A5 gene. Genotyping was done using PCR-RFLP method and validated by direct gene-sequencing. Trough levels of imatinib were measured using LC-MS/MS. Cytogenetic and molecular response were assessed by bone-marrow cytogenetics and qRTPCR using international scale, respectively. Results: A total of 173 patients were included, out of which 71 patients were imatinib responders, while 102 were non-responders. Marked inter-individual variability in trough levels of imatinib was seen. Patients with GG genotype for CYP3A5-A6986G (P=0.016) and TT genotype for MDR1-C3435T (P=0.013) polymorphisms had significantly higher imatinib trough levels. Patients with AA genotype for CYP3A5-A6986G [RR=1.448, 95%CI(1.126, 1.860), P=0.029] and CC genotype for MDR1-C1236T [RR=1.397, 95%CI(1.066, 1.831), P=0.06] & MDR1-C3435T [RR=1.508, 95%CI(1.186, 1.917), P=0.018] polymorphisms were at high risk for failure of imatinib therapy. GG vs. non-GG genotype for CYP3A5-A6986G [adjusted-OR: 0.246; 95%CI (0.116, 0.519); P<0.001] and TT vs. non-TT genotype for MDR1-C1236T [adjusted-OR: 0.270; 95%CI(0.110, 0.659); P=0.004] & MDR1-C3435T [adjusted-OR: 0.289; 95%CI(0.135, 0.615); P=0.001] polymorphisms were independent factors predicting imatinib response in multivariate analysis. Conclusions: MDR1 and CYP3A5 genetic polymorphisms significantly influence plasma trough levels and therapeutic response of imatinib in patients with CML. Genotyping of these polymorphisms could be of value to individualize the therapy and optimize the clinical outcomes.

Keywords: imatinib resistance, personalized medicine, P-glycoprotein, pharmacogenetics, single nucleotide polymorphisms


  PC Dandiya Prize Top



  PC DANDIYA PRIZE – 1: Terbinafine in Fixed Cutaneous Sporotrichosis: A Case Series Top


Singh Shailendra Vikram Jitendra, Romita Bachaspatimayum1, Usham Dharmaraja Meetei, A. Subhalakshmi Devi, Rita S

Departments of Pharmacology, 1Dermatology, Venerology and Leprosy, Regional Institute of Medical Sciences, Imphal, Manipur, India

Sporotrichosis is a chronic granulomatous mycotic infection caused by thermally dimorphic fungus, Sporothrix schenckii. The disease is endemic in tropical and subtropical belts throughout the world. In India, it is commonly seen in the Himalayan belt, frequently encountered in gardeners. Infection generally occurs by traumatic inoculation of soil and plants contaminated with the fungus. In humans, the lesions are usually restricted to the skin, subcutaneous cellular tissue and adjacent lymphatic vessels. Disseminated disease occurs when the fungus spreads throughout the body. The choice of antifungal agent in cutaneous sporotrichosis is limited. In vitro susceptibility studies and clinical experience support itraconazole as the treatment of choice for patients with most forms of cutaneous as well as extracutaneous sporotrichosis and amphotericin B as the preferred treatment for patients who are severely ill in disseminated mycotic infections. Itraconazole is a triazole antifungal agent which impairs the biosynthesis of ergosterols for cytoplasmic membrane. Terbinafine is a synthetic allylamine used as the drug of choice in tinea infections. It is a fungicidal drug which acts by non competitive inhibition of squalene epoxidase, an early step in ergosterol biosynthesis. This study compiles a case series of three cases of fixed cutaneous sporotrichosis, proven histopathologically, who were treated with terbinafine p.o. with dosage ranging from 250mg/day to 1 g/day, given upto 6 weeks after clinical resolution. The study may highlight the importance of terbinafine as an effective drug for sporotrichosis where affordability of itraconazole may be an issue.

Keywords: Itraconazole, sporotrichosis, terbinafine


  PC DANDIYA PRIZE – 2: Evaluation and Comparision of Anti Cancer Activity of Dapagliflozin and Canagliflozin: An In vitro Study Top


Nenavath Vinay, Darling Chellathai David

Department of Pharmacology, Sri Ramachandra Medical College and Research Institute, Chennai, Tamil Nadu, India

Objective: Every Cancer cell needs glucose to survive, Dapagliflozin and Canagliflozin are SGLT2 inhibitors which act as oral hypoglycemic drugs by inhibition of sodium glucose reuptake of cells. Our aim is to evaluate and compare the anticancer effect of these drugs by invitro MTT assay in KB-1 cells Methodology: The MTT assay was performed according to standard protocol under strict aseptic conditions. Dapagliflozin and Canagliflozin were added in various concentrations to KB-1 cell lines from 1000 μg/ml to 7.8 μg/ml. The Absorbance at 570nm was measured with UV-Spectrophotometer and IC50 values were determined graphically. Results: The present study indicate that the Canagliflozin and Dapagliflozin has exhibited anticancer effect on KB-1 cell lines at half maximal inhibitory concentration of 300μg/ml and 400μg/ml respectively. The maximum and minimum inhibitory concentrations of Canagliflozin are 74.79% and 11.72%, whereas for Dapagliflozin the maximum and minimum inhibitory concentrations are 64.26% and 10.75% respectively. Conclusion: The results suggest that the Canagliflozin has more significant loss of cell viability on KB-1 cell lines in comparison with Dapagliflozin and therefore Canagliflozin may possess potential anticancer effect than Dapagliflozin which requires further detailed in vitro and in vivo studies.

Keywords: Canagliflozin, dapagliflozin, KB-1 cell lines, MTT assay


  PC DANDIYA PRIZE – 3: Cellular Mechanisms of Hepatocyte-Hepatic Stellate Cell Interaction During Hepatic Fibrosis Top


Sowmya Mekala, Ramasatyaveni Geesala, Venkata Subba Rao Tulimilli, Amitava Das

Centre for Chemical Biology, CSIR-Indian Institute of Chemical Technology, Hyderabad, Telangana, India

E-mail: [email protected]

Objective: Hepatic fibrosis results due to reactive oxygen species generated by hepatotoxicant that leads to apoptosis of hepatocytes. It is hypothesized that various factors released by apoptotic hepatocytes, activate the hepatic stellate cells (HSC) thereby triggering fibrogenesis signaling. A critical understanding of hepatocyte-HSC interactions during hepatic fibrosis will lead to identification of newer targets for efficacious translational therapeutics. Thus, present study aims to identify the cellular signaling mechanism in apoptotic hepatocyte-induced HSC activation. Methods: In vivo hepatic fibrosis model were generated by administering carbon tetrachloride (CCl4) and/or thioacetamide (TAA) for a period of 6 weeks in C57BL/6J mice followed by tissue harvesting for histological, biochemical and molecular analysis. In vitro molecular mechanisms of hepatocyte-like cells-mediated human HSC activation were evaluated using conditioned media of hepatocellular carcinoma cells (HepG2) treated with CCl4/TAA. PDGFR-β blockers, sunitinib and dasatinib were used as negative controls. Results: 5-HP, TBARS, SGOT-SGPT and catalase assays along with Sirius Red, Masson's Trichrome and DHE staining and fibrosis-related gene expression suggested a hepatic fibrosis/injury by CCl4/TAA. A dose-dependent decrease in proliferation was observed in CCl4/TAA-treated HepG2 cells whereas the conditioned media led to an increase in proliferation and migration of HSC, an effect inhibited by sunitinib/dasatinib (10 nM). This effect was comparable to PDGF-BB/TGF-1β (10 ng/mL)-mediated increase in HSC proliferation, migration, fibrosis-related mRNA and protein expression and collagen content that was abrogated in presence of dasatinib. Conclusion: The study indicates mechanism of hepatoxicant-mediated liver injury that leads to release of factors for HSC activation, a target for anti-fibrotic therapies.

Keywords: CCl4/TAA, conditioned media, hepatic fibrosis, PDGFRβ, TGF-1β


  PC DANDIYA PRIZE – 4: Omeprazole Down Regulates Proinflammatory Cytokines and Oxidative Stress in Experimental Model of Chronic Constriction Injury Induced Neuropathic Pain Top


Sanket Gandhi, Sanjay Chanchal, Umesh B Mahajan, Sameer N Goyal, Chandragouda R Patil

Department of Pharmacology, R. C. Patel Institute of Pharmaceutical Education and Research, Dist-Dhule, Maharashtra, India

Introduction: Omeprazole wields anti-inflammatory and antioxidant effects through multiple mechanisms. However, its efficacy in neuropathic pain is scarcely investigated. Objective: In the present study, the effect of orally administered omeprazole (50 mg/kg/day for 14 days) was evaluated in the rat model of neuropathic pain. Methodology: Neuropathy was induced by unilateral chronic constriction injury (CCI) of the sciatic nerve. The intensity of neuropathic pain was estimated in terms of latency of the paw withdrawal against the mechanical and thermal allodynia. The extent of sciatic nerve injury of was evaluated through determination of the motor nerve conduction velocity and through histopathological examination of longitudinal sections of the nerve. Oxidative stress in nerve tissue was determined in terms of levels of lipid peroxidation, superoxide dismutase, catalase and reduced glutathione. The extent of inflammation response was studied in as rise in the TNF-α, IL-1β and IL-6 levels Results: Omeprazole significantly decreased the mechanical and thermal hyperalgesia and attenuated the levels of the tumour necrosis factor alpha, interleukin-1β and interleukin-6 in the sciatic nerve. It inhibited the constriction injury induced histological perturbation in nerve tissue and restored the motor nerve conduction velocity. These effects of omeprazole were less potent than that of the oral gabapentin at 60 mg/kg/day dose. Concurrently administered omeprazole and gabapentin however did not show any additive effects. Conclusions: These results indicate the protective effects of omeprazole against neuroinflammatory conditions. Further investigation is warranted to delineate the mechanism of antineuropathic and neuroprotective effects of omeprazole.

Keywords: Chronic constriction injury, cytokines, hyperalgesia, omeprazole

[TAG:2]PC DANDIYA PRIZE – 5: Ondansetron Ameliorates Depression Associated with Obesity in High Fat Diet Fed Experimental Mice: An Investigation Based on the Behavioral, Biochemical and Molecular Approach [/TAG:2]

Yeshwant Kurhe, Mahesh R

Department of Pharmacy, Birla Institute of Technology and Science, Pilani, Rajasthan, India

Objectives: Obesity remains an important risk factor for depression as more than 50% of the obese individuals are as likely to develop depression. Our earlier studies have reported the antidepressant potential of 5-HT3 receptor antagonist, ondansetron (OND) in depression associated obesity using several behavioral tasks. The present study investigates the effect of ondansetron on depression associated with obesity with main focus on biochemical and molecular mechanisms such as hippocampal brain derived neurotrophic factor (BDNF), cyclic adenosine monophosphate (cAMP), 5-HT, Immunohistochemical (IHC) expression of p53 proteins and hippocampal histological examination. Methods: Male Swiss albino mice were fed with high fat diet (HFD) for 14 weeks, followed by a treatment schedule for 28 days with vehicle/OND (0.5 and 1 mg/kg, p.o.)/reference antidepressant escitalopram (ESC) (10 mg/kg, p.o.). Subsequently, animals were screened in the behavioral tests of depression such as forced swim test (FST), sucrose preference test (SPT), biochemical estimations including hippocampal cAMP, BDNF, 5-HT and molecular assays such as p53 expression and histology of dentate gyrus. Results: HFD fed mice showed increased immobility time in FST, reduced sucrose consumption in SPT, decreased hippocampal cAMP, BDNF and 5-HT, and raised p53 expression, and hippocampal neuronal damage in the dentate gyrus region of HFD fed mice compared to normal pellet diet (NPD) control group. Repetitive treatment with OND (0.5 and 1 mg/kg, p.o.) significantly reversed the behavioral and molecular alterations in HFD fed mice compared to HFD control group. Conclusion: OND attenuates depression associated with obesity in HFD fed mice possibly through serotonergic neuromodulation.

Keywords: Brain derived neurotrophic factor, depression, obesity, ondansetron, serotonin

[TAG:2]PC DANDIYA PRIZE – 6: Antifibrotic Effect of NOX-II Inhibitor Apocynin in Rat Model of Thioacetamide Induced Liver Fibrosis [/TAG:2]

Kabariya Monika, Panchakshari Madhuri, Kirti V Patel, Shri SP Rathod

Faculty of Pharmacy, The Maharaja Sayajirao University of Baroda, Vadodara, Gujarat, India

Objective: To evaluate effect of Apocynin a NOX-II inhibitor in TAA induced liver fibrosis Methods: Male Sprague-Dawley rats (300-400 g; 6-8 weeks) randomly allocated in 6-groups. Normal control, Vehicle control: 0.2% CMC, Model control: Thioacetamide ;150mg/kg i.p, Standard treatment group: Silymarin 50mg/kg, Test treatment group –I: Apocynin 120mg/kg, Test treatment group –II : Apocynin 240mg/kg All groups (n=6) except normal control were given Thioacetamide(150mg/kg; i.p) three times a week for 6 weeks. Results: The TAA group showed abnormal liver function tests[alanine aminotransferase(ALT),aspartate aminotransferase(AST),Total Bilirubin content]as well as increased TGF-β1,Hydroxyproline content, liver weight, Spleen weight and decrease in plasma retinol content. Apocynin treatment prevented TAA induced changes. Biochemical analysis of redox status including MDA, reduced glutathione, NOX II also conforming TAA induced oxidative stress were decreased by Apocynin. Results are supported by histopathology. The results were comparable with the Silymarin used as standard in the study. Conclusion: Excessive extracellular matrix deposition based on complex interactions between matrix-producing hepatic stellate cells, liver regeneration and oxidative stress is the key mechanism of fibrosis in Thioacetamide (TAA) induced liver fibrosis. NOX-II is an enzyme from NADPH OXIDASE family which triggers the generation of oxidative stress in liver leading to fibrotic condition. From result it can be conclude that NOX-II inhibition (Apocynin) combats all these abnormalities and can be used as an alternative for current therapies.

Keywords: Apocynin, liver fibrosis, NOX-II, oxidative stress, thioacetamide


  PC DANDIYA PRIZE – 7: Geotaxis: an Early Age Behavioral Hallmark to Evaluate Sensory and Proprioceptive Function in VPA Rat Model of Autism Top


Rakesh K Ruhela, Shringika Soni, Ajay Prakash, Bikash Medhi

Department of Pharmacology, PGIMER, Chandigarh, India

Background and Purpose: Although autism can be developed in the animal model by VPA exposure at a particular time point of pregnancy, but further validation of the model by behavioral experiments is very much required. Experimental Approach: Groups of pregnant rats were received intraperitoneal injections of VPA 600 mg/kg during gestational day 12.5. Neonatal body weights, body height, eye opening, motor function and sensorimotor function were found to alter in VPA treated groups. Geotaxis test was performed at PND 6, 10,15 and 17 of age in which rat is placed on a 45° inclined slope with head-down position and time taken to rotate 180° (negative geotaxis) from head-down to head-up position was recorded. This experiment was done both in the presence and absence of light to rule out the effect of eye opening. Key Results: The results of the present experiments demonstrate that VPA exposed rats exhibit: (1) delayed maturation, (2) lower body weight & height, (3) greater motor function and (4) enhanced negative geotaxis. Conclusions and Implications: Our results are advocating the negative geotaxis test as a reliable predictor of autism in early age of rats and it could distinguish VPA treated autistic animal model for other neurodevelopmental disorders as developmental and behavioral aberrations appear before puberty.

Keywords: Autism spectrum disorder, early age behaviour, face validity, neurodevelopmental disorder

[TAG:2]PC DANDIYA PRIZE – 8: Cost of Antipsychotic Treatment and Quality of Life Assessment in Outpatients of a Tertiary Care Hospital in Delhi. [/TAG:2]

Shankar Kumar, Shalini Chawla

Department of Pharmacology, Maulana Azad Medical College, New Delhi, India

Objectives: The present study was conducted to estimate cost incurred on antipsychotic treatment in terms of cost per prescribed daily dose (PDD) of individual antipsychotics and to assess quality of life of patients over the study period. Methods: The study was prospective and observational in nature conducted in Outpatients Psychiatry department of a tertiary care hospital for a duration of 1 year. A total of 224 patients who were prescribed antipsychotics irrespective of diagnoses were included. PDD of individual antipsychotics was determined and cost was noted using latest edition of Drugs Today©. Quality of life assessment was determined using WHO- QOL BREF scale at initial visit and after 3 months of antipsychotic therapy. Results: Cost per PDD was maximum with amisulpride (34.25 INR) and the most commonly prescribed antipsychotics, risperidone (5.03 INR) and olanzapine (8.8 INR) had intermediate costs. 54% of the total cost over study period was attributed to antipsychotics like amisulpride and aripiprazole which were prescribed to only 8.4% patients. Significant improvements were noted at 3 months on all four domains; physical, psychological, social and environmental, compared to baseline. Olanzapine was better than clozapine, risperidone, and trifluoperazine on physical domain scores. Similarly, olanzapine scores were better compared to risperidone, and clozapine on psychological domain scores. Conclusions: The study concludes that newer and costlier antipsychotic prescription even to a small subset of population could constitute a major proportion of total expenditure. Few antipsychotics performed better suggesting that prescription of such antipsychotics would be rational, cost effective and meaningful.

Keywords: Antipsychotic, cost, prescribed daily dose, quality of life


  PC DANDIYA PRIZE – 9: Utilization and Cost of Antimicrobials Used in Medicine and Surgery Departments of a Tertiary Care Teaching Hospital Top


Bimba HV, Vandana Roy

Department of Pharmacology, MaulanaAzad Medical College, New Delhi, India

Objective: This study is conducted to analyse the pattern of use of antimicrobials, expenditure incurred and to correlate the antimicrobial usage with clinical or bacteriological evidence of infection. Methods: The observational study was conducted in the outpatient and inpatient departments of two units of Medicine and Surgery of a Tertiary care hospital in Delhi over a period of 14 months. A total 2128 randomly selectedprescriptions and 200 case sheets were reviewed and analysed using International Classification Code of Diseases for diagnosis, Anatomical Therapeutic Chemical Classification (ATC) and Defined Daily Doses (DDDs). Results: In the outpatient department, the percentage of encounters with antimicrobials in Medicine (53.3%) was greater than in Surgery (25.9%). The most commonly used antimicrobial in both departments was amoxicillin+clavulanate. In the inpatient department, 73.1% of the admitted patients were prescribed antimicrobials. The total DDDs/100 patient days of antimicrobials in Medicine and Surgery were 3369 and 2247, respectively. The evidence of infection for the antimicrobial use was mostly clinical. The antimicrobial therapy was found to be appropriate in 88% of cases as per Kunin's criteria for rationality. The most commonly used antimicrobials in the inpatients were ceftriaxone, metronidazole and flouroquinolones. Overall expenditure on the antimicrobials was 33% of the total cost of drug treatment majority of which was due to newer expensive antimicrobials which were used only in a small percentage of patients. Conclusion: We propose routine practice of bacterial culture and sensitivity testing, formulation of an antibiotic policy, and antimicrobial stewardship program to improve usage and clinical outcome.

Keywords: Antimicrobial, cost, defined daily dose, Kunin criteria, rational drug use


  Oral Top



  AIN (ANTI-INFLAMMATORY) Top



  AIN – 1: Efficacy and Safety of Hydroxychloroquine as an Add-On Drug to Acelofenac in Chikungunya Arthritis Top


Jayanthi CR, Mithun Kumar D

Department of Pharmacology, Bangalore Medical College and Research Institute, Bengaluru, Karnataka, India

Objective: To assess the efficacy and safety of Hydroxychloroquine as an add-on drug to aceclofenac in chikungunya arthritis. Mateirals and Methods: 40 patients diagnosed with Chikungunya arthritis not responding to initial one week of Tab. Aceclofenac 100 mg BD were randomised to two groups, A and B. Group A was given Tab. Hydroxychloroquine 200 mg BD as an add-on to aceclofenac 100 mg BD whereas group B was given Tab. Aceclofenac-SR 200 mg OD. Both the groups were followed up at 3, 6, 9 and 12 weeks. Efficacy was assessed by Disease Activity Score-28 (DAS-28) and Health Assessment Questionnaire-Disability Index (HAQ-DI) scales. Safety was assessed by monitoring adverse drug reactions. Data analysis was done using one-way ANOVA for intragroup comparison and unpaired t-test for intergroup comparison of the efficacy. Results: Both the study groups A and B showed significant improvement in mean DAS-28 and HAQ-DI scores at the end of 12 weeks compared to their baseline (p<0.05). Group A patients achieved significantly greater improvement in mean DAS-28 and HAQ-DI scores compared to group B patients (3.13 vs 4.2; p=0.0004 for DAS-28 scores; 0.67 vs 0.93; p=0.023 for HAQ-DI). Nausea, vomiting and pain abdomen were the most common adverse effects and were comparable between the groups (9 in group A, 8 in group B). Conclusions: Hydroxychloroquine as an add-on is equally safe and more efficacious than sustained release aceclofenac (200 mg OD) after initial non-response to usual dose aceclofenac (100 mg BD) in chikungunya arthritis.

Keywords: Aceclofenac, chikungunya arthritis, hydroxychloroquine


  AIN – 2: Anti-Fibrotic Effect of Esculin on Thioacetamide Induced Hepatic Fibrosis in Mice Top


Harjinder Singh, Jena GB

Department of Pharmacology and Toxicology, National Institute of Pharmaceutical Education and Research, S.A.S. Nagar, Punjab, India

Objective: Effects of esculin on thioacetamide-induced hepatic fibrosis in mice. Methods: Animals were randomised into six groups. Group 1: control (normal saline), Group 2: vehicle control (0.5% CMC), Group 3: esculin control (120mg/kg/day), Group 4: thioacetamide control (150mg/kg/ two days interval), Group 5: thioacetamide + esculin low dose (thioacetamide: 150mg/kg/two days interval + esculin: 60 mg/kg/day) and Group 6: thioacetamide + esculin high dose (thioacetamide: 150mg/kg/two day interval + esculin: 120 mg/kg/day for 6 weeks. Route of administration for thioacetamide and esculin was intraperitoneal and per oral respectively. Results: Esculin treatment increased percent survival, restored body weight, SGPT levels, reduced lipid peroxidation, increased glutathione content in a dose-dependent manner as compared to thioacetamide control. It also significantly restored SGOT levels in esculin treated groups as compared to thioacetamide control group. In haematoxylin and eosin staining, localisation of inflammatory cells, cellular degeneration and necrosis was also decreased in a dose-dependent manner in esculin treated groups as compared to thioacetamide control. Significant decrease in percent fibrotic area was observed in esculin treated groups in a dose-dependent manner as compared to thioacetamide control. Esculin treatment also significantly reduced the expression of TGF-β1, α-SMA, TNF-α and MMP-2 in a dose-dependent manner as compared to thioacetamide control. Conclusion: In conclusion, esculin showed promising anti-fibrotic activity and prevented the development of thioacetamide-induced experimental hepatic fibrosis in mice.

Keywords: Esculin, fibrosis, inflammation, liver, thioacetamide


  AIN – 3: Comparative and Interaction Studies on Probiotic, Synbiotic and NSAID against Experimental Osteoarthritis in Rats Top


Jayakanth K, Ravi Kumar P, Boobalan G, Gopala Reddy A

Department of Veterinary Pharmacology and Toxicology, College of Veterinary Science, Hyderabad, Telangana, India

E-mail: [email protected]

Objectives: An experimental study was conducted to evaluate and compare the therapeutic potential of probiotic, synbiotic and NSAID against MIA-induced osteoarthritis in rats. Methods: Seventy male Wistar albino rats were randomly divided into seven groups. Group 1 was kept as normal control throughout the experimental period. Remaining 6 groups were induced OA by intra-articular injection of MIA. After 48 h, all those induced rats were diagnosed for OA, and were included in the study. Treatment protocols were initiated from day 0 post-confirmation of OA and continued for 28 days. Group 1: Non-OA control; group 2: MIA (2mg in 50 μl normal saline, intra-articular route) - induced OA control; group 3: probiotic (Lactobacillus plantarum 21 (LAB)) in OA rats; group 4: synbiotic (combination of LAB) and Fructo-Oligo Saccharide (FOS) in OA rats; group 5: NSAID (Ibuprofen) in OA rats; group 6: LAB and Ibuprofen in OA rats, and group 7: Synbiotic and NSAID in OA rats. Results: The results revealed significant changes in body weights, haematology, alkaline phosphatase and myeloperoxidase levels, and in cytokine levels in osteoarthritis group compared to normal group. These changes were well reversed by all the treatment groups and significant improvement was noticed. Of all the treatments, combination of synbiotic with NSAID was more effective in reversing the changes. Conclusions: The study revealed that probiotic has the potential to minimize the effects of osteoarthritis but the changes were more predominant when combined with probiotic and NSAID.

Keywords: Ibuprofen, FOS, LAB 21, NSAID, Osteoarthritis


  AIN – 4: Effect of Flavonoids Against Complete Freund's Adjuvant - Induced Rheumatoid Arthritis in Rats Top


Boobalan Gopu, Baranidharan Kalakumar, Alla Gopala Reddy

Department of Veterinary Pharmacology and Toxicology, College of Veterinary Science, Hyderabad, Telangana, India

E-mail: [email protected]

Objectives: An experimental study was conducted to investigate the anti-rheumatic potential of morin and rutin in combination with methotrexate in Complete Freund's adjuvant (CFA) induced arthritis in Wistar albino rats. Materials and Methods: Rats were divided uniformly into 7 groups and treated as follows: Group 1 as normal control throughout the experimental period. Remaining 6 groups were induced rheumatoid arthritis (RA) by sub plantar injection of CFA in right hind paw. After 72 h, all RA induced rats were taken for the study. Treatment protocols were initiated from day 0 post-confirmation of RA and continued for 21 days. Group 1: Non-RA control, group 2: CFA (0.1 mL @ 10% single dose, sub plantar route) - induced RA control, group 3: methotrexate (MTX) @ 1 mg/kg/week ip once, group 4: morin @ 50 mg/kg po once daily, group 5: rutin @ 25 mg/kg po once daily, group 6: MTX (as in group 3) + morin (as in group 4) and group 7: MTX (as in group 3) + rutin (as in group 5). Physiological, sero-biochemical and antioxidant parameters were estimated. Results: CFA-induced RA exhibited oxidative stress in joints, elevated arthritis score, paw volume and thickness, and alterations in associated sero-biochemical parameters and histo-architecture of joints. All these effects were significantly alleviated by methotrexate and flavonoids in test. Conclusions: The combination of morin or rutin with methotrexate was found superior to individual drugs owing to a variety of pharmacodynamic actions of MTX and flavonoids that resulted in synergism.

[TAG:2]AIN – 5: Parallel Group Open Label Study to Determine the Effect of Hydroxychloroquine on Insulin Sensitivity in Rheumatoid Arthritis Patients [/TAG:2]

Gourav Yadav, Tripathi CS, Punia VPS, Kabi BC, Ashish Kumar Kakkar

Background: Previous studies suggest that Hydroxychloroquine (HCQ) may reduce the risk of diabetes mellitus in patients with rheumatoid arthritis (RA). However, there is lack of published literature that clearly explains the effect of HCQ on insulin resistance in rheumatoid arthritis patients. Therefore, this study was done to evaluate the effect of HCQ treatment on insulin sensitivity in patients of RA in Indian population. Material and Methods: The patients diagnosed with RA were divided into two groups, Group A receiving Methotrexate (7.5mg/week) and Group B receiving Methotrexate (7.5mg/week) and Hydroxychloroquine (200 mg BD). All subjects underwent OGTT with 75 mg glucose at 0 month {pre-treatment}, 1 month, 3months {end of study}. Blood samples were collected at 0 hour, 1 hour and 2 hour to determine fasting blood glucose (G0), fasting insulin level(I0), mean blood glucose level(G) and mean insulin level(I). Using data from the above investigations we calculated insulin sensitivity index ISI (matsuda), insulin resistance (HOMA-IR), pancreatic β cell function (HOMA-β) which are the markers of insulin sensitivity. These were compared at baseline and end of the study in both the groups. Results: In group A there was no significant change from baseline for ISI & mean was 3.02 ± 0.11 at baseline and 3.01 ± 0.09 at the end of 3rd month (p>0.05). In group B ISI mean increased from 2.96 ± 0.27 at baseline to 3.77 ± 0.28 at 3 month (p<0.05). Difference between mean values of ISI for group A and group B was not significant at baseline but significant at 1 month and 3 month (p<0.05). HOMA-IR mean values for group A showed increase in values from 2.96 ± 0.18 to 3.03 ± 0.16. In group B there was decrease in HOMA-IR mean values from 3.13 ± 0.38 to 2.35 ± 0.28. Difference between group A and group B values for HOMA-IR at baseline, 1 month and 3 month were significant (p<0.05). HOMA- β values in group A increased from 147 ± 16.84 to 221.56 ± 25.20. In group B it increased from 152.29 ± 23.76 to 172.44 ± 34.44 (p<0.05). Conclusions: In this study we found that use of HCQ was associated with significant improvement in insulin sensitivity over three month period of treatment.

Keywords: Hydroxychloroquine, Rheumatoid Arthritis, Insulin sensitivity.

[TAG:2]AIN – 6: Ameliorative Effect of Flavonoid Rich Fraction of Martynia annua on Collagen-Induced Arthritis with Reducing Oxidative Stress in Mice [/TAG:2]

Santram Lodhi, Gautam P Vadnere, Md. Rageeb, Md. Usman, Salgar SD, Patil KD

Smt. Sharadchandrika S. S. Patil College of Pharmacy, Chopda, Jalgaon, Maharashtra, India

E-mail: [email protected]

Objective: Martynia annua Linn. (Martyniaccae) is traditionally used in inflammation and applied locally to tuberculosis glands of camel's neck. The leaves are used topically on bites of venomous insects and wounds of domestic animals. Chemical examination of Martynia annua leaves revealed the presence of glycosides, tannins, proteins, phenols and flavonoids. Materials and Methods: The present study was aimed to evaluate the anti-arthritic activity of methanolic extract of Martynia annua leaves. Methanolic extract of Martynia annua leaves were tested by using in vivo collagen-induced arthritis mouse model to investigate the anti-rheumatoid arthritis activity. In addition, antioxidant effect of methanolic extract was determined by the estimation of antioxidants level in joint tissues. The severity of arthritis was assessed by arthritis score and edema. Levels of cytokines TNF-α and IL-6, in the joint tissue homogenate were measured using ELISA. Results: A high dose (250 mg/kg) of methanolic extract was significantly reduced the degree of inflammation in mice as compared with reference drug. Antioxidants level and malondialdehyde (MDA) in joint tissue homogenate found significantly (p< 0.05) higher. Methanolic extract at dose of 250 mg/kg modulated the cytokines production and suppressed the oxidative stress in the mice with collagen-induced arthritis. Conclusions: This study suggested that Martynia annua might be alternative herbal medicine for the management of rheumatoid arthritis.

Keywords: Antioxidantas, collagen, flavonoids, Martynia annua, rheumatoid arthritis


  AIN – 7: Evaluation of In vitro Anti-Inflammatory and Anti-Nociceptive Activity of Alkaloid Enriched Fraction of Tribulus terrestris(Nerunjil) in Chronic Constriction Injury Model Top


Praveen Asokan, Ramanathan M

PSG College of Pharmacy, Coimbatore, Tamil Nadu, India

Objective: The present study aimed to evaluate the anti-inflammatory and anti-nociceptive activity of alkaloid enriched fraction of Tribulus terristris (Nerunjil) in LPS treated RAW 264.7 murine macrophage cell lines (in-vitro) and chronic constriction injury model (in-vivo). Methods: The anti-inflammatory and anti-nociceptive activities were evaluated in MTT assay by LPS induced inflammation in RAW 264.7 cell lines and hot plate (thermal hyperalgesia), Von Frey & Paw pressure (mechanical allodynia and hyperalgesia) and formalin (peripheral mechanism) tests. Further, sciatic nerve functional loss was evaluated using sciatic functional index. To support the behavioural studies histopathological examination and anti- inflammatory markers such as TNF-α, IL-1β, iNOS PCR studies has been performed. Results: The results have shown that alkaloid enriched fraction (100mg/kg) of Tribulus terristris (Nerunjil) shown significant response both in-vitro and in-vivo models. Conclusions: The study has been concluded that alkaloid enriched fraction of Tribulus terristris (Nerunjil) is effective anti-inflammatory and anti-nociceptive herb in LPS induced inflammation and CCI model. The mechanism of action is through controlling inflammation.

Keywords: Allodynia, hyperalgesia, inflammation, lipopolysaccharide, nociception

ANS (AUTONOMOUS NERVOUS SYSTEM)


  ANS – 1: Impact of Cholinergic Pathways on Insulin Levels in Patients with Impaired Glucose Tolerance Top


Lahiry Sandeep, Chatterjee Mitali, Chatterjee Sudip1

Department of Pharmacology, Institute of Post Graduate Medical Education and Research, 1Department of Medicine, Vivekananda Institute of Medical Sciences, Kolkata, West Bengal, India

Objectives: To assess the role, if any, of cholinergic pathways on plasma insulin levels in patients with impaired glucose tolerance. Materials and Methods: Subjects (n=10) with impaired fasting glucose (IFG) were recruited following screening visits while six age and gender matched healthy subjects served as the control group. Baseline glycemic status was assessed, after which subjects underwent an oral glucose tolerance test (OGTT, glucose 75 g at 0 min.) in the absence and presence of Hyoscine (40 mg PO; single dose; at -30 min.) two or three days apart. Venous blood samples were thereafter obtained at 0, 30, 60, 90 and 120 min for estimation of glucose and insulin. Results: In IFG subjects, hyoscine did not alter the mean plasma glucose (PG) and insulin levels whereas in healthy controls, hyoscine lowered the PG at 60 and 90 min. Similarly, hyoscine had no effect on plasma insulin levels in IFG subjects, whereas in healthy controls, the rate of insulin secretion and elimination was altered. No association was observed between the 'peak' insulin levels and the percentage fall in glucose concentration per min. Conclusions: At sub-therapeutic doses, oral anticholinergics have some impact on glucose induced insulin response, which may be augmented using therapeutic doses.

Keywords: Hyoscine, insulin, oral glucose tolerance test


  AUTO (AUTOCOID PHARMACOLOGY) Top


[TAG:2]AUTO – 1: Effect of Endoplasmic Reticulum Stress Inhibitor on Neuropathic Pain [/TAG:2]

Thapak P, Sharma SS

Department of Pharmacology and Toxicology, National Institute of Pharmaceutical Education and Research, S. A. S. Nagar, Punjab, India

Objectives: To establish CCI and Paclitaxel (PTX) neuropathic pain models and evaluate the effect of ER stress inhibitor on the behavioral, functional and biochemical parameters in CCI and PTX induced neuropathic pain.

Materials and Methods: Neuropathic pain was induced by paclitaxel (2mg/kg) in rats and by chronic construction injury of sciatic nerve. Thermal hyperalgesia measured by the planter test and mechanical allodynia and hyperalgesia measured by vonfrey and randall selitto test respectively. Functional parameters like MNCV (motor nerve conduction velocity) and NBF (nerve blood flow) were measured. Pregabalin was administered for 7 days after CCI and 4th week after PTX induced neuropathic pain at 30 mg/kg dose i.p. Effect of 4-Phenylbutyric acid (PBA) was investigated in CCI and PTX model of neuropathic pain. Results and Conclusions: A significant decrease in the behavioral (thermal and mechanical hyperalgesia) parameters was observed after CCI and PTX induced neuropathic pain and functional (MNCV and NBF) parameters after PTX induced neuropathic pain. Pregabalin (30 mg/kg, i.p) was used as a standard drug for the validation of neuropathic pain model. Treatment with pregabalin showed the significant reversal of behavioral and functional parameters. 4-Phenylbutyric acid (PBA), ER stress inhibitor showed significant reversal of behavioral and functional parameters. This study demonstrates the protective effects in CINP (PTX) induced neuropathic pain.

Keywords: 4-phenylbutyric acid, CCI, CINP, neuropathic pain, pregabalin

[TAG:2]AUTO – 2: Investigation of the Involvement of Protease Activated Receptors in Neuropathic Pain using Pharmacological Interventions [/TAG:2]

Rohit D Singh, K Resham, Sharma SS

Department of Pharmacology and Toxicology; National Institute of Pharmaceutical Education and Research, S.A.S.Nagar, Punjab, India

Objectives: To investigate the effect of argatroban and cromolyn sodium on chronic constriction injury (CCI)-induced neuropathic pain model. Materials and Methods: CCI was induced in rats and different nociceptive parameters like thermal hyperalgesia (Hargreaves's plantar test), cold hyperalgesia (Tail immersion test) and mechanical hyperalgesia (Randall Selitto test) were measured on 0, 4, and 7th day after treatment with pregabalin (30 mg/kg), argatroban (0.1, 1 mg/kg si.p.) and cromolyn sodium (1, 10 and 30 mg/kg i.p.) for 7days after CCI. Western blotting studies was also performed to estimate the changes in PAR expression in control and CCI animals. Results and Conclusions: A significant decrease in the values of thermal, cold and mechanical hyperalgesia clearly indicated the development of neuropathic pain characteristics in rats using chronic constriction injury. Treatment with pregabalin produced reversal of CCI induced neuropathic pain. Argatroban (0.1, 1 mg/kg i.p.) significantly reversed the thermal and mechanical hyperalgesia on 4th and 7th day. Cromolyn sodium (10 and 30 mg/kg i.p) reversed mechanical hyperalgesia on 4th and 7th day, while cold and thermal hyperalgesia on 7th day only. Also, western blotting studies confirmed significant changes in the expression of PAR-1 and not PAR-2 in sciatic nerves of CCI-induced rats.

Keywords: Argatroban, chronic constriction injury, cromolyn sodium, neuropathic pain, pregabalin


  AUTO – 3: Modulation of Cyclooxygenase and Nitric Oxide Pathways Contribute to the Analgesic Effect of Osthole Top


Gurjit Singh, Palwinder Singh1, Anudeep Kaur, Rajbir Bhatti

Departments of Pharmaceutical Sciences and 1Chemistry, Guru Nanak Dev University, Amritsar, Punjab, India

Objectives: Osthole (7-Methoxy-8-isopentenoxy coumarin), a naturally occurring coumarin, has been been documented to have an interesting biological profile in several preliminary studies. The current investigation is aimed at exploring the analgesic and anti-inflammatory activities of osthole. Materials and Methods: Swiss albino mice were used. Analgesic and anti-inflammatory activities of osthole (10 mg/kg) were determined by formalin and acetic acid induced hyperalgesia and anti-inflammatory activities were investigated using carrageenan induced paw edema. Modulation of COX and iNOS pathway were studied by pretreatment with substance P, L-arginine and L-NAME respectively. Results: Osthole treatment was found to reduce the number of flinchings in formalin induced hyperalgesia and number of writhings induced by acetic acid significantly. Also, paw inflammation induced by carrageenan was significantly reduced. Pretreatment with substance P, L-arginine and flumazenil were found to reverse the analgesic effect of osthole. Conclusions: It is concluded that osthole has significant analgesic and anti-inflammatory drug in mice and the plausible modulation of COX and iNOS pathway may be contributing to the analgesic effect of osthole.


  IMP (INFLAMMATORY PHARMACOLOGY) Top



  IMP – 1: Flavanoids Rich Fraction of Citrus limetta Alleviates Paracetamol-Induced Acute Liver Injury Through Regulation of Inflammation and Oxidative Stress Top


Anant Kumar, Monika Singh, Karuna Shanker1, Anil Kumar Maurya, Archana Saxena, Dnyaneshwar U Bawankule

Departments of Molecular Bioprospection and 1Analytical Chemistry, CSIR-Central Institute of Medicinal and Aromatic Plants, Lucknow, Uttar Pradesh, India

E-mail: [email protected]

Objectives: To explore the hepatoprotective effects of ethyl acetate extract of Citrus limetta(ClEt) fruit peels through regulation of oxidative stress and inflammation against paracetamol induced hepatotoxicity in mice. Materials and Methods: Experimental mice were orally pretreated with ClEt at the dose of 100, 200 and 400 mg/kg for 7 days. The hepatotoxicity was induced by single oral administration of paracetamol (800 mg/kg body weight). Serum was used for the quantification of hepato-toxic markers and pro-inflammatory cytokines while biomarkers of oxidative stress were estimated in liver homogenate. Chemical signature of ClEt was developed by using the high performance liquid chromatography fingerprinting. Results: ClEt @ 100, 200 and 400 mg/kg significantly (p<0.05) ameliorate the level of hepatic enzymes and pro-inflammatory cytokine (TNF-α, IL-6, IL-1β) as well as decrease the overproduction of thiobarbituric acid-reactive substances (TBARS), and nitric oxide (NO) while increase the activity of catalae and superoxide dismutase. Chemical fingerprint shows the presence of flavanoids. Conclusions: The result of the study revealed that flavanoids rich fraction of citrus limetta(ClEt) alleviates paracetamol-induced acute liver injury through regulation of inflammation and oxidative stress and could be further explored as a drug like candidates for management of liver diseases.

Keywords: Citrus limetta, hepatoprotective, inflammation, Oxidative stress, paracetamol


  IMP – 2: A Case of Drug Hypersensitivity due to Sodium Valproate Top


Rajesh Kumar Jangir, Anusuya Gehlot, Narendra Kumar Swami, Javed Ahamed, Akhtar Ali, Jignesh Kumar

Department of Pharmacology, Dr. S. N. Medical College, Jodhpur, Rajasthan, India

Objectives: Drug Allergy(also called drug hypersensitivity) is an immunologically mediated reaction producing stereotype symptoms which are unrelated to the pharmacodynamic profile of the drug, may occur even with much smaller dose and have a different time course of onset and duration. In many cases the allergic reaction is mild, in severe cases can lead to shock and may be life threatening. Hives, rashes and fever are common symptoms.Treatment involves discountinuing the medication that caused reaction and other medications such as antihistaminics; in severe cases bronchodilators or epinephrine may be needed. Materials and Methods: Case Presentation: A 35 year old patient was admitted on 25/05/2016 with complaints of altered sensorium, insomnia, muteness and history of chronic alcoholism with diagnosis of Psychosis NOS (Not Otherwiswe Specified). On 25/05/2016 treatment was started: (1) Tab. Sodium valproate 200mg TDS (2) Tab. Risperidone 2mg BD (3) Tab. Chlorpromazine 50mg OD (4) Tab. Trihexyphenidyl 2mg TDS . After taking Sodium valproate patient complained itching and mild rashes all over body on same day. Results: Hypersensitivity reaction due to Sodium valproate diagnosed by clinical examination. Hypersensitivity reaction was started due to Sodium valproate, next day tab. Sodium valproate was stopped and inj. Haloperidol 4mg and inj. Promethazine 20mg IV stat was given. Conclusions: Since, patient had altered sensorium, muteness, etc. He was started with Sodium valproate that in turn induced hypersensitivity reaction and more worsening of psychosis symptoms, to achieve better control inj. Haloperidol and inj. Promethazine were given. This combination improved both worsened psychosis symptoms and hypersensitivity reaction.

Keywords: Drug hypersensitivity reaction, haloperidol, promethazine, sodium valproate


  IMP-3: Cholinergic Antagonists Influence Neuroinflammation and Memory Dysfunction Via Cholinergic Breakdown In Exprimental Global Cerebral Ischemia Reperfusion Injury Top


Ray RS1,2, Anju Katyal2

1Pharmacology Research Laboratory, University Institute of Pharmaceutical Sciences, Panjab University, Chandigarh, 2Dr. B. R. Ambedkar Center for Biomedical Research, University of Delhi, New Delhi, India

E-mail: [email protected]

Objectives: Global cerebral ischemia induced reperfusion injury (GCI/R) in humans is clinically evidenced in situations like cardiac arrest, asphyxia, drowning or severe systemic hypotension during a surgical procedure. Central cholinergic system modulate neuroinflammatory brain injury and numerous studies demonstrate cholinomimmetic drugs ameliorate cerebral ischemia/reperfusion injury induced neurological deficit and ensuing memory dysfunction. Methods: Bilateral common carotid artery occlusion (BCCAO) was induced in C57Bl/6J mice for 45min followed by 7 days of reperfusion. In the present study, we investigated the effects of sustained suppression of cholinergic receptors using scopolamine (0.1 mg/kg i.p.) and mecamylamine (0.5 mg/kg i.p.) on neuroinflammation and memory dysfunction in mouse model of global cerebral ischemia/reperfusion injury. Results Cholinergic blockade by scopolamine and mecamylamine following BCCAO displayed severe neurobehavioral alterations on Morris water maze and Passive avoidance. Furthermore, cholinergic antagonists altered muscarinic and nicotinic receptor expression along with AChE and ChAT levels thereby confirming the crucial involvement of cholinergic system in memory performances following GCI/R. In addition, RT-PCR and Immunofluorescence studies demonstrated that altered hippocampal mRNA expression of cholinergic indices, inflammatory markers and apoptotic genes after GCI/R injury. These findings indicate further exacerbation of GCI/R injury following cholinergic receptor blockade in C57Bl/6J mice. Conclusions: These results suggest that sustained suppression of cholinergic receptor following GCI/R insult modulates hippocampal neuroinflammatory response as bystander phenomenon potentiating cognitive impairment. The outcomes of present study together with earlier reports highlights the importance of cholinergic integrity and preservation of both muscarinic and nicotinic receptor functions in maintaining memory functions following GCI/R injury.

Keywords: Cholinergic system, global cerebral ischemia, mecamylamine, memory dysfunction, scopolamine


  BP (BEHAVIOURAL PHARMACOLOGY) Top



  BP – 1: Evaluation of Anxiolytic Activity of Aqueous Extract of Nerium oleander Flowers in Albino Rats Top


Shilpa BN, Shashikala GH, Mansi J Shah, Rahul HD

Department of Pharmacology, JJMMC, Davangere, Karnataka, India

Objectives: To evaluate the anxiolytic activity of aqueous extract of Nerium oleander flowers (AE) in albino rats in comparison with diazepam. Materials and Methods: 48 albino rats aged 6–7 weeks, of either sex, weighing about 200–250 g, were taken. The animals were divided into four groups. Group I- normal saline, 10ml/kg (control), Group II –diazepam, 2mg/kg (control), Group III- TEST 1 (200mg/kg), Group IV –TEST 2 (400mg/kg) of the AE orally. Anxiolytic activity was assessed by 1.Elevated plus maze (EPM)- number of entries and time spent in open arm 2.Actophotometer (locomotor activity)- number of crossings across light beams. Statistical comparison of four groups for anxiolytic activity was done with ANOVA. Multiple comparisons done with Tukey's Post Hoc. Results: The results from the Elevated plus maze and Actophotometer showed that AE significantly reduced (P < 0.00) the anxiety of the tested animals when compared to control group. In EPM, total number of entries and time spent in open arm are increased in test groups compared to control. In Actophotometer, locomotor activity of test groups was decreased compared to control group. Where as AE 200mg/kg and 400mg/kg were comparable with standard drug diazepam in actophotometer model. Conclusions: In both EPM and actophotometer model, both the doses of AE showed significant anxiolytic effect in albino rats. However further studies are required to support these observations.

Keywords: Actophotometer, anxiolytic, elevated plus maze, nerium oleander


  BP – 2: Evaluation of Anxiolytic Effect of Furosemide in Albino Wistar Rats Top


Malvika Goyal, Jyothi CH, Rahul H Damodar, Shashikala GH

Department of Pharmacology, JJMMC, Davangere, Karnataka, India

Objective: To evaluate the anxiolytic effect of furosemide at three different doses (75mg/kg, 150mg/kg and 200mg/kg) in albino wistar rats. Materials and Methods: After obtaining approval from the institutional animal ethical committee 30 Albino wistar rats weighing about 150-200 gm were taken and divided into 5 groups of 6 rats each. Group 1: Normal Saline 10ml/kg (control); Group 2: Diazepam 2mg/kg (standard); Group 3: Furosemide 150mg/kg (test group 1); Group 4: Furosemide 200mg/kg (test group 2); Group 5: Furosemide 75mg/kg + Diazepam 1mg/kg (subthreshold dose). The anxiolytic activity of furosemide was tested by elevated plus maze and actophotometer models. Data was analyzed using one way ANOVA followed by Posthoc Tukey's test. Results: Furosemide (150mg/kg and 200mg/kg) have shown significant increase in open arm entries (p< 0.000) and time spent in open arm (p<0.000 & p<.002) compared to control. Also furosemide (150mg/kg and 200mg/kg) have shown statistically significant decrease in locomotor activity (p<0.008) compared to control in actophotometer model. Potentiation of time spent and number of entries in open arm and decrease in locomotor activity were noticed when subthreshold doses of combination of diazepam and furosemide were used. Conclusions: These results suggest that furosemide possesses significant anxiolytic activity at both the doses. Furosemide given in subthreshold dose potentiates the antianxiety effect of subthreshold dose of diazepam when used in combination. Hence, after further studies, furosemide can be used as an anxiolytic drug.

Keywords: Actophotometer, elevated plus maze, furosemide


  BP – 3: MCI-186 Attenuates Chronic Restraint Stress-Induced Behavioural Deficits through Suppressing the Endoplasmic Reticulum Stress Signalling and Upregulation of Brain-derived Neurotrophic Factor Level in the Hippocampus Top


Ashok Jangra1, Chandra shaker Sriram1, Mangala Lahkar1,2

1Department of Pharmacology and Toxicology, National Institute of Pharmaceutical Education & Research, 2Department of Pharmacology, Gauhati Medical College, Guwahati, Assam, India

E-mail: [email protected]

Objective: The primary objective of our study was to investigate the neuroprotective efficacy of MCI-186 against restraint stress (RS)-induced behavioural alterations in mice. Materials and Methods: Adult male swiss albino mice (22-25 g) were restraint for 6 h/day for 28 days and injected (i.p.) with MCI-186 (3 and 10 mg/kg) for last seven days. To evaluate the behavioural functions, forced swimming test (FST) and Morris water Maze (MWM) test were performed. Brain-derived neurotrophic factor (BDNF) content, proinflammatory cytokines (IL-1β and TNF-α) level and expression levels of ER stress-associated genes were determined in the hippocampus region. Results: RS-exposed mice showed depressive-like behaviour as indicated by increase in immobility time in the FST. In addition, MWM test revealed the learning and memory deficits in RS-exposed animals as compared to control group. These behavioral alterations were accompanied by rise in proinflammatory cytokine levels, reduction in BDNF content in the hippocampus after 28 days of RS exposure. Moreover, results of western blotting and real-time PCR revealed the upregulation of ER stress markers, GRP78 and CHOP in the hippocampus of RS-exposed mice. MCI (10 mg/kg) was found efficient to abolish the RS-induced behavioural anomalies. In addition, MCI (10 mg/kg) treatment suppressed proinflammatory cytokines and ER stress along with augmentation of BDNF level. Conclusions: These results indicate that MCI-186 can protect RS-induced cognitive impairment and depressive-like behaviour via upregulation of BDNF level and suppression of ER stress. Therefore, MCI-186 could be an intriguing pharmacological intervention for the treatment of neurological disorders.


  BP – 4: Honokiol Attenuates Acute Restraint Stress-Induced Depressive-Like Behaviour in Mice: Role of TrkB-BDNF Signalling Pathway Top


Kunjbihari Sulakhiya1,2, Chandana C Barua3, Vijay Paramanik4

1Department of Pharmacology and Toxicology, Laboratory of Neuroscience, National Institute of Pharmaceutical Education and Research, 3Department of Pharmacology and Toxicology, College of Veterinary Sciences, Assam Agriculture University, Guwahati, Assam, 4Department of Zoology, Faculty of Science, Indira Gandhi National Tribal University, 2Centre for Excellence for Indigenous Knowledge, Indira Gandhi National Tribal University, Amarkantak, Madhya Pradesh India

E-mail: [email protected]

Stress is implicated in the pathogenesis of psychiatric disorders including depression. It induces neuroinflammation and oxidative stress thereby modulates BDNF-TrkB signalling mechanism. Honokiol (HNK) is a biphenolic neolignan possess multiple biological activities including antioxidant, anti-inflammatory, anxiolytic, antidepressant and neuroprotection. This study investigated the effect of HNK against acute restraint stress (ARS)-induced depressive-like behaviour and alteration in TrkB-BDNF signalling in mice. Fifty mice were randomly divided into five groups (n=10) and 6 h ARS procedure was employed to induced neurobehavioral and biochemical changes in mice. HNK (5 mg/kg, p.o.) and imipramine (15 mg/kg, p.o) was administered to the animals daily for 7 days and on 8th day subjected to ARS. Depressive-like behaviour was measured through different behavioural paradigms such as forced swim (FST) and tail suspension test (TST) 40 min post-ARS. Pro-inflammatory cytokines (IL-1β & TNF-α), TrkB, BDNF, oxidative stress parameters (MDA & SOD) level were analyzed in hippocampal homogenates. HNK and imipramine pre-treatment significantly attenuated ARS-induced increase in the immobility time in FST and TST. An increase in IL-1β, TNF-α, MDA level post-ARS was prevented significantly whereas decreased level of TrkB, BDNF and GSH level were improved significantly with HNK and imipramine pre-treatment. In Conclusions, HNK showed antidepressant activity in stressed mice by activating TrkB-BDNF signalling through inhibiting inflammatory-oxidative process. Thus, HNK could be used in the treatment of stress related psychiatric disorders.

Keywords: Acute restraint stress, BDNF, depression, honokiol, inflammation


  BP – 5: To Compare the Efficacy and Safety of Escitalopram and Vilazodone in Major Depressive Disorder Top


Brij M Gupta, Palvi Kudyar, Rakesh Banal

Department of Pharmacology, GMC, Jammu, Jammu and Kashmir, India

Background: Major depressive disorder (MDD) with a global incidence of 4.7% is a prevalent & disabling illness associated with significant impairment of physical & social functioning as well as increased morbidity & mortality. The essential feature of MDD is a period of at least 2 weeks during which there is depressed mood or the loss of interest & pleasure in nearly all daily activities. The individual must have 4 additional symptoms including change in appetite, weight, sleep, psychomotor activity, decreased energy, feeling of guilt, ideas of death & suicidal ideation. These are defined as per the DSM IV criteria for depression. A large number of effective anti depressant medications are available but their utility is limited by the adverse effects caused by them. Escitalopram is an effective selective serotonin reuptake inhibitor (SSRI) approved for use in major depressive disorder in adults & children >12 years. Vilazodone is a newer SSRI and partial serotonin receptor agonist approved for MDD. Aims and Objectives To evaluate and compare the efficacy & safety of Escitalopram & Vilazodone in patients of depression Materials and Methods The prospective, randomized study was conducted in the DEPTT OF PSYCHIATRY, GMC JAMMU in collaboration with the DEPTT OF PHARMACOLOGY, GMC JAMMU. A total of 30 patients were taken between the ages of 18-55 years of either sex diagnosed with major depression based on DSM IV criteria. Patients with pregnancy, using other psychotropic drugs were excluded from the study. Patients were assigned randomly into two groups to receive either escitalopram or vilazodone and baseline scores of HAM A & HAM D were recorded. These were then assessed at 8 weeks for post drug scores. Results: Average age of the patients taken was 39.16 years with a male: female ratio of 13:17. The HAM D score was significantly lowered by escitalopram (p<0.0001) and vilazodone also effected HAM D score in similar manner (p<0.0001). Similarly, HAM A score was significantly lowered by escitalopram (p<0.0001) and vilazodone also effected HAM A score in similar manner (p<0.0001). HAM D score with escitalopram was significantly lowered as compared to vilazodone (p=0.0037) HAM A score with escitalopram was significantly lowered as compared to vilazodone (p=0.0497) Biochemical profile (blood sugar, serum urea, creatinine, haemoglobin, TLC) was not altered with either of the drugs over 8 weeks. No significant ADRs were noted with the drugs. Conclusions: Outcome of the present trial has clearly demonstrated that both drugs are effective in decreasing depression & anxiety scores in patients of major depression. On comparison, Escitalopram proved to be more effective than Vilazodone (p<0.05).

Keywords: Anxiety, depression, escitalopram, Ssri, vilazodone

[TAG:2]BP – 6: Screening of Alcohol De-Addiction Potential of Zinc: A Study on Wistar Albino Rats [/TAG:2]

Sharanabasayyaswamy B Hiremath, Priya Gandigawad

Department of Pharmacology, SDM Medical College, Dharwad, Karnataka, India

Objectives: Evidences from cellular level studies support possible de-addiction potential of zinc. Present study aims at analyzing alcohol de-addiction potential of zinc in Wistar albino rats. Materials and Methods: Twenty-four Guinea pigs were divided into four groups with six animals in each group as control (1ml/kg plain water), ZnSo4 (18mg/kg/d), topiramate (5mg/kg/d) and topiramate+ZnSo4 treated groups. All the animals were treated with their respective drugs, once daily orally for 10days in 'two-bottle free choice' screening model of voluntary ethanol (10% v/v) consumption. Volume of alcohol, water and food consumed in terms of g/kg body weight at the beginning and at the end of the study were noted. Alcohol Preference Index (API) was estimated by using the volume of alcohol and water consumed by each animal. Mean changes in these parameters between the four test groups were noted and significance of the differences were estimated using two-way ANOVA and Bonferroni post-hoc test. Results: There was no significant difference with regard to API, volume of alcohol and food consumed between all the groups after ANOVA test. However, there were significant differences between four groups with regard to volume of alcohol, water and food consumed after post-hoc test. Conclusions: Considering the contradictory results from ANOVA and post-hoc test, it appears that the individual groups differ with regard to the four parameters but the amount of this difference observed between the groups may not be significant to validate the results as therapeutically significant results.

Keywords: Alcohol de-addiction, topiramate, ZnSo4


  BP – 7: Effects of Neurosteroids on Stress-Induced Changes in Immunological and Biochemical Markers in Rats Top


Arora G, Ray A, Gulati K

Objectives: To study the effects of chronic restraint stress (RS) on immunological and biochemical markers in rats:Immunological markers: Serum Immunoglobulin G (IgG) levels, Delayed type hypersensitivity (DTH) response and cytokine levels – Interferon-γ (IFN-γ) and Interleukin-4 (IL-4).Biochemical markers: Malondialdehyde (MDA) and Reduced Glutathione (GSH) levels.To evaluate the effects of Dehydroepiandrosterone sulfate (DHEAS) on stress-induced changes in above markers in rats. Methods: Male Wistar rats were used in study. DHEAS was given in doses of 10 and 20 mg/kg. 1 hour RS was used as experimental stressor. Rats were immunized with KLH on day 0. After drug treatments as per protocol design, from day 1 to day 14, rats were challenged on day 14 and DTH assay performed using Plethysmometer, and bled on day 15 from retro-orbital plexus. Immunological and biochemical markers were analyzed in blood. Results: Chronic RS induced immunosuppression and these changes were attenuated by DHEAS pre-treatment. On exposure to RS, there was marked increase in IL-4 levels; attenuated by DHEAS pre-treatment, on the other hand, there were consistent reductions in IFN-· levels in stressed rats, reverted towards basal level by DHEAS pre-treatment. It was also found that such chronic RS elevated MDA levels while lowered GSH levels, and these changes were attenuated by DHEAS pre-treatment. Conclusions: DHEAS ameliorated chronic RS induced suppression of humoral as well as cell-mediated immunity in dose related manner. Also, these effects of DHEAS were comparable to prototype anti-stress agent, diazepam, on most parameters.


  BP – 8: Lactobacillus plantarum Mitigates Neurobehavioural Deficits and Gastric Dysbiosis in Sleep Deprived Mice Top


Shiyana, Jatinder Dhaliwal, DhirendraPratap Singh, Shashank Singh1, KanthiKiran Kondepudi1, Mahendra Bishnoi1, Anil Kumar P2, Kanwaljit Chopra

Pharmacology Division, University Institute of Pharmaceutical Sciences, Panjab University, 2Microbial Type Culture Collection and Gene Bank, CSIR – Institute of Microbial Technology, Chandigarh, 1National Agri-food Biotechnology Institute, SAS Nagar, Mohali, Punjab, India

E-mail: [email protected]

Objective: Exploration of the effect of a probiotic, Lactobacillus plantarum, in sleep deprivation induced behavioral, biochemical aberrations and gastric dysbiosis in mice. Methods: Male Swiss albino LACA mice were sleep deprived for 72 hours and allocated to four different groups; consisted of control, sleep deprived (SD), L. plantarum (2×1010 CFU/day for 17 days) supplemented SD mice and per se group. Behavioral tests to assess spontaneous locomotor activity, depression and anxiety like behaviors were conducted 20–22 hours after the last L. plantarum dose administered on day 17th followed by quantification of selected caecal gut bacteria and SCFAs, biochemical and permeability estimations on day 21. Results: Mice subjected to SD protocol for 72 hours displayed alterations in various behavioral, biochemical and molecular markers along with perturbations in the abundances of selected gut bacteria. SD mice also demonstrated increased depression and anxiety-like behaviors, elevated oxidative/nitrosative stress status and increased intestinal permeability. No alterations were observed in the SCFAs profile. Supplementing the SD mice with the probiotic strain L. plantarum (2×1010 CFU/day, p.o) for 17 days not only significantly attenuated behavioral and biochemical deficits but also effectively reversed the stress induced intestinal barrier deficits. Conclusions: Current study suggests a role for microbiota in regulating central events such as stress responses, neuroinflammation and thus it is tempting to speculate that modulation of the gut microbiota via chronic treatment with probiotic strains such as L. plantarum may serve as a tractable strategy in counteracting the deleterious consequences of stressor exposure.

Keywords: Lactobacillus plantarum, LPS, NF-κβ, Probiotics, SCFA, Sleep deprivation


  CEL (CELLULAR/MOLECULAR PHARMACOLOGY) Top



  CEL – 1: Antioxidants in Combination with Lithium Provides Neuroprotection to Glutamate Induced Damage of Retinal Ganglion Cells Top


Mahak Tiwari, Madhumita P Ghosh

Amity Institute of Biotechnology, Amity University, Noida, Uttar Pradesh, India

Retinal ganglion cells have N-methyl D-aspartate receptors which undergo excitotoxic damage on exposure to glutamate. Damage of retinal ganglion cells (RGCs) is characteristic of various ophthalmic diseases like glaucoma, optic neuropathy, age related macular degeneration, diabetic retinopathy etc. Regeneration of RGCs is not possible due to neural nature of the retina. Trials to provide neuroprotection to the retinal ganglion layer is being partially successful to treat the symptoms of glaucoma, diabetic retinopathy etc. Our study is an effort to examine the effect of lithium on glutamate induced damage of retinal ganglion cells. Intravitreous injection of NMDA was used to create invivo model of retinal ganglion layer degeneration. Lithium which is known to treat neuronal diseases like bipolar disorder supports growth of retinal ganglion cells in vitro aswell as invivo. NMDA injection followed by intraperitoneal injection of lithium at three doses of 30, 50 and 70 mg/kg to Wister rats was found to provide protection to RGCs. These neuroprotective effect of lithium was through expression of antiapoptotic protein Bcl2. Lithium was most effective at the concentration of 30mg/kg in protecting the retinal ganglion cells. Antioxidants ,coenzyme Q and vitamin E when combined with lithium was further effective in preventing the damage of RGCs. These results were confirmed by H & E staining of paraffin sections ,immunostaining of cryosections and transmission electron microscopy of the retinal sections from animal model of retinal ganglion cell degeneration.


  CEL – 2: Kinetic Characterization of Therapeutic Antibodies Binding to Adherent Tumor Cells Top


João Encarnação1,2, Sina Bondza1,2, Jonas Stenberg1, Karl Andersson1,2

1Ridgeview Instruments AB, Vänge, 2Department of Immunology, Pathology and Genetics, Uppsala University, Sweden

E-mail: joão encarnação, [email protected]

Objectives: During the development and optimization of therapeutic antibodies it is important to analyze their binding properties such as affinity and kinetics. Members of the ErbB receptor family such as EGFR and Her2 are aberrantly expressed in a variety of solid cancers and thereby promote tumor growth. Due to their oncogenic properties both receptors are targets for clinically approved therapeutic antibodies. We present a measurement approach in which the binding of a drug to a receptor expressed on living cells can be observed in real-time by using LigandTracer® Green (Ridgeview Instruments AB, Sweden). Methods: Binding of the antibodies Cetuximab and Trastuzumab to living cancer cells was followed with an indirect fluorescent label consisting of a small Alexa488 labeled small protein (FIBA) known to bind the Fc-terminus of humanized antibodies. This circumvents the need to label each antibody individually and ensures that the antibody binding site stays intact. Results: The interaction between therapeutic antibodies and FIBA was confirmed to be stable and FIBA itself did not bind to the cells. Measurements of on-rate, off-rate and affinity of FIBA-Cetuximab and FIBA-Trastuzumab binding to cancer cells were reproducible and in agreement with historic results. Conclusions: In Conclusions, we demonstrate that our assay can be used to reliable study and compare the binding of drugs to living cancer cells in vitro. Our method can therefore be used in the development of new drugs as well as in the screening and optimization of biosimilars.

Keywords: Antibodies, EGFR, LigandTracer, real-time


  CEL – 3: Enabling Real-Time Measurements of Molecular Interactions on Living Immune Cells Top


Sina Bondza1,2, Karl Andersson1,2, Jos Buijs1,2

1Ridgeview Instruments AB, Vänge, 2Department of Immunology, Pathology and Genetics, Uppsala University, Sweden

Objectives: Understanding how the immune system interacts with signaling molecules and drugs is crucial for the development and validation of drugs for a plethora of diseases. The binding of a signaling molecule or drug candidate to the target receptor can be complex and dependent on a number of factors such as receptor dimerization or cluster formation. To be able to fully understand how a receptor interacts with a given molecule it is therefore important to measure their interactions in a relevant cellular context. Methods: LigandTracer® is an instrument that measures in real-time how molecules bind to living, adherent cells. We present a new method that enables detailed characterization of interactions using immune cells which grow in suspension. As an example of a drug-immune cell interaction, we monitored how the therapeutic antibody Rituximab binds to CD20 on living B-cells. For this purpose B-cells and CD20 negative cells, serving as control, were adhered to petri-dishes through a non-covalent tethering. Binding of FITC-labeled Rituximab to B-cells and to CD20 negative cells was measured in real-time with LigandTracer Green (Ridgeview Instruments AB, Sweden). Results: The measurements were highly reproducible and the resulting apparent affinities were in the range of 0.7-1.1 nM (n=7) and indicated that Rituximab binds in a heterogeneous manner. Conclusions: We confirm that our in vitro assay allows for detailed characterization of molecular interactions on immune cells. This assay can be used to e.g. study the behavior of new drug candidates in vitro in a relevant and easy to manipulate model system.

Keywords: Real-time measurement, drug-receptor interactions, immunology, CD20


  CEL – 4: Cinnamaldehyde, A TRPA1 Agonist Prevents High Fat Diet Induced Weight Gain, Fatty Liver and Endocrinological Disturbances Top


Pragyanshu Khare1,2, Kamlesh K Bhutani3, Shyam S Sharma4, Kanthi K Kondepudi1, Kanwaljit Chopra2, Mahendra Bishnoi1

1National Agri-Food Biotechnology Institute, Departments of 3Natural Products and 4Pharmacology and Toxicology, National Institute of Pharmaceutical Education and Research, SAS Nagar, Punjab, 2Department of Pharmacology, University Institute of Pharmaceutical Sciences, Panjab University, Chandigarh, India

Background: Obesity and associated metabolic disorders has been considered as big health problem of 21st century which is associated to multiple endocrinological disturbances in the body. Aim of the present work is explore the role of cinnamaldehyde a transient receptor potential ankyrin A1 (TRPA1) channel agonist in high fat diet associated endocrinological disturbances. Methods: In-vitro experiments were performed in mouse derived 3T3L1 cell lines and in-vivo experiments were performed in high fat diet induced mouse model of obesity. Different hormonal levels were determined using competitive ELISA method both in vitro and in vivo samples. Gene expression studies were performed using RT-PCR method. Results: Cinnamaldehyde treatment prevented the conversion of preadipocytes into adipocytes and 24 h cinnamaldehyde treatment in mature 3T3L1 adipocytes dose dependently reduced the leptin secretion without any effect on adiponectin levels. CInnamaldehyde co-administration with high fat diet in mouse prevented weight gain, visceral adiposity and hormonal imbalance induced by chronic high fat diet feeding. Serum leptin, resistin and insulin levels were significantly decreased after chronic cinnamaldehyde treatment. The decrease in serum adiponectin was normalised and increased ratio of leptin:ghrelin was reversed after cinnamaldehyde co-administration with high fat diet. Conclusions: Our finding suggests that cinnamaldehyde could be a good preventive tool to overcome the sedentary life style associated weight gain, non alcoholic fatty liver disease and endocrinological disturbance.


  IND (INDEGENOUS DRUGS) Top



  IND – 1: Potential Role of Phyllanthus fraternus Against Cyclophosphamide Induced Cardiotoxicity in Rats Top


Moirangthem Rakesh Singh, Meena Devi N, Rita S, Kh. Sucheta Devi1

Departments of Pharmacology and 1Pathology, RIMS

Objectives: This study was undertaken to investigate the possible protective effect of aqueous extract of Phyllanthus fraternus (AEPF) against cyclophosphamide induced myocardial toxicity in rats. Materials and Methods: Wistar rats were given cyclophosphamide single i.p. injection (200 mg/kg) on day 1 of the experiment and two doses of AEPF (200 mg/kg , 400 mg/kg) p.o. daily for 10 days . Cardiac biomarker enzymes like creatinine kinase ( CK ), creatinine kinase isoenzyme MB ( CK-MB ), lactate dehydrogenase

( LDH ), alkaline phosphatase ( ALP ), alanine transaminase ( ALT ) and aspartate transaminase ( AST ) were determined. Histopathological sections of the heart were also made. Results: CP treated groups exhibited significantly ( p < 0.05 ) increased in cardiac biomarker enzymes. Treatment with AEPF prevented the elevation of these enzymes. Potential protective effect was also seen in histopathological examination of the heart characterized by decreased myocardium cell damages in AEPF treatment group. Conclusions: The study showed the protective role of AEPF in dose dependent manner. The possible role of antioxidant is anticipated.

Keywords: Biomarkers, cardiotoxicity, cyclophosphamide, histopathological, Phyllanthus fraternus


  IND – 2: Hypolipidaemic Effect and Diuretic Activity of the Ethanolic Extract of the Leaves of Bryophyllum pinnatum in Experimental Animals Top


Binita Singha, Mangala Lahkar

Department of Pharmacology, Gauhati Medical College and Hospital, Guwahati, Assam, India

Aims and Objectives: This study was undertaken with the objective of studying the hypolipidaemic effect and diuretic activity of the ethanolic extract of the leaves of Bryophyllum pinnatum in experimental animals. Materials and Methods: Hyperlipidaemia was induced in rats by a cocktail diet containing cholesterol, peanut oil, cholic acid and propylthiouracil. Hypolipdaemic activity of Bryophyllum pinnatum was then evaluated at doses 100mg/kg, 200mg/kg and 400mg/kg and compared with a standard, Atorvastatin. Total cholesterol, triglycerides, HDL, LDL and VLDL were determined to assess the hypolipidaemic effect. Diuretic effect of Bryophyllum pinnatum was evaluated at the same doses and compared with Urea as the standard. Diuretic effect was assessed by Lipschitz method. Results and Observations: Ethanolic extract of the leaves of Bryophyllum pinnatum showed significant hypolipidaemic effect at all the doses but the effect was highest with 400mg/kg dose (p < 0.01). There was significant reduction in the levels of total cholesterol, triglycerides, LDL and VLDL compared to the hyperlipidaemic control group. The extract also showed significant diuretic activity at all the doses and was almost similar to the standard, Urea. Conclusions: From the above results it can be concluded that the ethanolic extract of the leaves of Bryophyllum pinnatum possessed significant hypolipidaemic and diuretic effects but further investigations have to be done to understand the exact mechanism of the effects.

Keywords: Bryophyllum pinnatum, cocktail, diuretic, hyperlipidaemia, Lipschitz


  IND – 3: Alleviation of Pharmaco-Medico-Social Problems of Cancer Patients in India Top


Mirza MA, Ramesh S, Hasan M

Teaching Hospital and Research Centre Shadan Institute of Medical Sciences, Hyderabad, Telangana, India

Objective: Cancer patients undergoing radiation-therapy (RT) suffer from many side-effects like dermatitis and mucositis, the latter being the most debilitating. Radiation burns decreases the patient's confidence and mucositis disturbs their speech, food intake, sleep and comfort, which further adds to the depressing situation. Hence better remedies are warranted. Materials and Methods: In our work, by correlating physiological damage and cellular biology in RT patients, an ointment was prepared using the resin Sarja rasa (Ayurveda)/ Vellaikungiliyam (Siddha)/ Raal (Unani). This is obtained by incising and tapping the tree, Vateria indica Linn having wound-healing properties and is also anti-sarcomic. The seminal study was carried out with the permission of ethics committee, targeting patients affected with head and neck/ hand and foot cancers. Guidelines of do's and dont's for topical treatments recommended for RT patients were followed. In addition, it was felt important to ascertain sterility, stability and particle size. Results: A remarkable change was observed in terms of the decrease in severity of symptoms and duration of healing. The progression to the next stage of skin damage was slow and the time of healing found to be shortened when compared to the control group, attributed to its penetration on the skin and therapeutic action monitored. Secondly, it was observed that due to compromised socio-economic background, immune-suppressed by the cancer treatment, the patients seem susceptible to develop RT burns. It is felt that also dealing with body hygiene in such patients may have added further to the healing response. Conclusions: This study showed that various streams of experts can contribute under pharmacologist in drug discovery and development.

Keywords: Particle size, radiation reactions, sterility, Vateria indica

[TAG:2]IND – 4: To Evaluate the Safety Profile of Homeopathic Drugs Used in Arthritis [/TAG:2]

Prerna Chauhan, Ritu Karwasara, Surender Singh, Gupta YK

Department of Pharmacology, All India Institute of Medical Sciences, New Delhi, India

Objectives: In Homeopathic system of medicine, the drugs are documented for the treatment of various ailments. However, there is lack of safety studies on these medicines. Present study was carried to evaluate the safety profile of Homeopathic drugs used in arthritis (Ferrum Phos 3X, Ferrum Phos 6X, Calcarea Phos 6X and Magnesium Phos 6X). Methods: Toxicity studies were performed using Wistar rats. Acute oral toxicity study was performed as per OECD-425 guidelines. Sub-acute toxicity study for 28 days according to OECD-413 and chronic toxicity study for 180 days as per OECD-452 guidelines. Animals were observed daily for clinical signs of toxicity. Blood samples collected for biochemical analysis. Organs were harvested, weighed and histopathological analysis was done. Results: For acute toxicity study (14 days), dose level of 2000mg/kg in rats, showed LD50 >2000mg/kg. During sub-acute (28 days) and chronic toxicity study (180 days), no changes in body and organ weight were observed. There were no significant changes in biochemical parameters (hepatic transaminase, triglycerides, high density lipoprotein, creatinine level) and hematological parameters (hemoglobin, RBC, WBC, platelets, clotting and bleeding time). Histopathological pictomicrographs showed no morphological changes as compared to control group. Conclusions: In acute toxicity study, no mortality or signs of toxicity were observed up to dose level of 2000mg/kg. In sub-acute and chronic toxicity studies, there were no significant changes in mean organ weight and no signs of gastric ulceration. Biochemical, hematological and histopathological analysis showed no significant differences.

Keywords: Arthritis, homeopathy, OECD guidelines, toxicity


  IND – 5: Tephrosia purpurea Linn. Intervention in the Retrieval of Toxic Manifestations Due to Anti-Tuberculer Drug Administration Top


Javid Ahmad Malik, Monika Bhadauria

Department of Zoology, Toxicology and Pharmacology Laboratory, Guru Ghasidas Central University, Bilaspur, Chhattisgarh, India

Tephrosia purpurea Linn. belonging to family febaceae possesses a remarkable potential by being spasmolytic, bronchodilator, vasorelaxant, antidiarrheal agent and is also known for reducing hepatobilary and splenic complications. But, its mechanism of protection against anti-tuberculosis drugs(ATDs) induced hepatobilary and renal disorders is yet to be elucidated. The present study was conducted to investigate conjoint effect of plant extract against experimental hepato-renal toxicity induced by ATDs administration. The hepato-renal toxicity was induced by administrating ATDs thrice a week for 8 weeks. Meanwhile Tephrosia purpurea (100, 200 and 400 mg/kg) plus toxicant ATD treatment was given along with for 8 weeks simultaneously. Toxic manifestations of ATDs and curative effects of Tephrosia extract was assessed by performing various hematological parameters, liver and kidney function tests, marker of oxidative stress and histopathological studies. Cytochrome P4502E1 (CYP4502E1) activity was determined as hydroxylation of aniline in liver microsomes. Various blood and serum biochemical indices were found towards control with co-treatment with Tephrosia extract. Lipid profile (cholesterol and triglycerides) and lipid peroxidation in liver, kidney and microsomes were increased with ATDs administration whereasglutathione, catalase, superoxide dismutase, glycogen, total and microsomal protein were decreased. Tephrosia extract reversed the changes towards control in dose dependent manner. Biochemical determinations were corroborated by histological studies.Thus, it can be inferred that Tephrosia possess significant protection against ATDs induced hepato-renal toxicity, which may be due to the presence of various bioactive components in plant extract.


  IND – 6: Propolis Attenuates Hepatorenal Oxidative Stress, Antioxidant Status, Histopathology and Ultrastructural Changes in High Fat Diet and Ethanol Treated Rats Top


Hemeshwer Kumar Chandra, Monika Bhadauria, Sangeeta Shukla1

Department of Zoology, Toxicology and Pharmacology Laboratory, Guru Ghasidas University, Bilaspur, Chhattisgarh, 1Department of Zoology, Reproductive Biology Laboratory, Jiwaji University, Gwalior, Madhya Pradesh, India

Objectives: Alcohol abuse lead the several diseases and millions of death world-wide. High fat diet are major contributor for non-alcoholic liver diseases, liver failure and obesity. This study was carried out to evaluate the protective effect of propolis on combined consumption of high fat diet (HFD) and ethanol induced hepatorenal injuries. Methdos: Rats were feed HFD 30% and ethanol 10% for 4 week along with different doses of propolis 100, 200 and 400 mg/kg and 50 mg/kg dose of silymarin. Results: Combined consumption of HFD and alcohol increased serum aspartate transaminase, alanine transaminase, alkaline phosphatase, bilirubin, urea, uric acid, creatinine, triglycerides and cholesterol and decrease the glucose and albumin. Administration of propolis restored serum variables towards control. HFD and alcohol increased hepatorenal lipid peroxidation, triglycerides, cholesterol and hepatic ADH, ALDH and CYP2E1; and decreased superoxide dismutase, catalase, glutathione peroxidase, glutathione reductase, glucose-6-phosphate dehydrogenase and glutathione. Administration of propolis altered all biochemical variables towards control and maintained ultra and light histoarchitecture. Conclusions: Present study concluded that administration of propolis may alleviate HFD and ethanol induced hepatorenal damage through preventing lipid accumulation, protecting antioxidant system and histoarchitecture due to the presence of phenolic compounds in its extract.

Keywords: Alcohol, caffeic acid, HFD, oxidative stress


  IND – 7: Antiinflammatory Activity of Ziziphus xylopyrus willd. Stem Bark Extract in Experimental Animals Top


Marndi Gujaram, Rath B, Mohapatra S, Biswal SB

Department of Pharmacology, VIMSAR, Burla, Odisha, India

E-mail: [email protected]

Introduction: India is a country with diversity of medicinal plants which are well recognized and they are being used by people for treating different ailments with fewer adverse reactions. Ziziphus xylopyrus is one such plant belonging to the family Rhamnacae. Various parts of this plant reported to be possessing anti-convulsant, antibacterial, anti-inflammatory and analgesic activity etc. Hence this study was undertaken to evaluate the possible anti-inflammatory activity of ethanol extract of stem bark extract of Ziziphus xylopyrus (EEZX) in two experimental animal models of inflammation. Material and Methods: The study was carried out in Wistar albino rats (150-200 gm). EEZX was prepared by using soxhlet process. The effect of EEZX stem bark was investigated for anti-inflammatory activity by using Carrageenan induced rat paw edema for acute inflammation and Cotton pellet induced granuloma method for chronic inflammation by giving EEZX at doses of 100, 200 and 400 mg/kg P.O. Indomethacin and diclofenac were taken as standard drugs for acute and chronic models respectively. Results: EEZX showed statistically significant anti-inflammatory effect in both the models of inflammation.

Keywords: Anti-inflammatory, diclofenac, EEZX, indomethacin


  IND – 8: An Experimental Study to See the Antihypertensive Effect of Gymnema sylvestre and Acorus calamus in Wistar Rats and Its Comparison with Standard Drug Top


Dheeraj Kumar Singh, Dixit RK, Amod Kumar, Nath R, Sarvesh Singh, Rahul Kumar, Narendra Kumar

Department of Pharmacology, King George's Medical University, Lucknow, Uttar Pradesh, India

Objectives: The prevalence of obesity is increasing worldwide. Obesity has a direct correlation with insulin resistance and various cardiovascular diseases like hypertension, dyslipidaemia etc. The present study was designed to see the antihypertensive effects of Gymnema sylvestre (GS) and Acorus calamus (AC), individually as well as in combination, in Wistar rats. Methods: Female Wistar rats, weighing between 150- 200 gm, were included in the study. They were divided into six groups with six rats in each group. High Fat diet (HFD) was used to induce hypertension in all the groups except group I which was fed with normal rodent diet. Drugs were given to the rats by oral feeding cannula. Results: Feeding rats with HFD for 4 weeks lead to significant increase in the mean systolic blood pressure. After giving drugs GS (200mg/kg), AC (200mg/kg), GS+ AC (200mg/kg+ 200mg/kg) and Amlodipine (10mg/kg) to groups III, IV, V and VI respectively, mean systolic blood pressure fell significantly (p <0.05) in group III, V and VI as compared to group II (HFD control group) at the end of 8th week. There was no significant difference in mean systolic blood pressure between group I (Normal control group), III, V and VI. Conclusions: The present study concludes that combination of GS and AC extract has significant antihypertensive action in rodent model of hypertension.

Keywords: Acorus calamus, gymnema sylvestre, high fat diet, hypertension, rats


  IND – 9: A Study of Drug Use Pattern in Connective Tissue Diseases and its Impact on Quality of Life Top


Jani KK, Desai CK, Kapadia JD, Desai MK

Department of Pharmacology, B.J. Medical College, Ahmedabad, Gujarat, India

Objectives: To evaluate the drug use pattern in connective tissue diseases (CTDs) and its impact on Quality Of Life (QOL). Methods: It was an observational, prospective, single centre study. Patients newly diagnosed with CTDs were enrolled and followed up at 1, 3 and 6 months. Drug use pattern was evaluated by WHO CORE prescribing indicators. Defined Daily Doses (DDD) were calculated for all drugs. Adverse drug reactions and QOL (using WHO-QOL BREF questionnaire) were evaluated at each visit. Results: Total 80 patients (mean age: 35.4±12.6 years, male: female-1:19) diagnosed with Systemic Lupus Erythematosus(30),Systemic sclerosis(30),Mixed CTD (8), Dermatomyositis (7) and Sjogren Syndrome(5) were enrolled. DMARDs, Immunosupressants, Vasodilators and NSAIDs were commonly prescribed. Average number of drugs per encounter was 4.84. Generic prescribing was observed 38.54% and 91.4% drugs prescribed were from EDL. No antibiotics were prescribed while injections prescribed were 1.3%. Methotrexate (L01BA01) and prednisolone (H02AB06) were most commonly prescribed drugs with a DDD of 125 and 116 respectively. QOL was significantly improved at 3 months (p<0.01) & 6 months (p<0.001). Health-Satisfaction was significantly increased at 3 & 6 months (p<0.001).Significant improvement in Domain 1(physical health) was seen at 6 month compared to 1 month (p<0.001), domain 2 (Psychological health) at 3 & 6 months (p<0.001), domain3 (Social-relationships) at 6 months(p<0.001) and domain4 (Environment) at 6 months (p<0.001). ADRs like gastritis (5), headache(5), nausea(5), weightgain(4), hyperpigmentation(3), rash(2), dizziness(2) and chestpain(1) were observed. Conclusions: Though majority of drugs are prescribed from EDL, generic prescribing, use of antibiotics and injectable are low. QOL of CTD patients improves with treatment on long term. Periodic assessment of QOL is recommended in these patients.

Keywords: Connective tissue diseases, quality of life, systemic lupus erythematosus, systemic sclerosis, WHO QOL-BREF Questionnaire


  IND – 10: TNF-α, IL-6 AND IL-10 Expression in Kidney: Responsible for Disparity in Action of Curcumin Against Cisplatin-Induced Nephrotoxicity in Rats Top


Parveen Kumar, Abhishek Mishra1, Kunjbihari Sulakhiya2, Chandana C Barua3

Department of Pharmacology, Bhojia Dental College and Hospital, Solan, Himachal Pradesh,1Department of Pharmacology, PGIMER Chandigarh, 2Department of Pharmacology and Toxicology, NIPER, 3Department of Pharmacology and Toxicology, College of Veterinary Science, AAU, Khanapara, Guwahati, Assam, India

Aim: Cisplatin induced kidney damage is a grave problem which borders, its use in tumor chemotherapy. Inflammatory mechanisms are believed to play a dominant role in the cisplatin-induced kidney damage. The purpose of this study was to examine the pre and post-treated effects of curcumin on cisplatin-induced nephrotoxicity. Methods: Curcumin pre and post-treatment (120 mg/kg) for 5 days before and after cisplatin injection (7.5 mg/kg) was implemented to check the renoprotective effects of curcumin. Renal functions, various inflammatory markers and renal histopathology were investigated to confirm the renoprotective effect of curcumin. Results: Cisplatin intoxication resulted in structural and functional renal impairment which was revealed by massive histopathological changes and elevated BUN and creatinine levels, respectively. Curcumin pre-treatment for 5 days significantly decreased both the damage to renal function and kidney architecture after cisplatin injection, which was, clearly evident from the reduced BUN, creatinine and improved renal histopathology. Moreover, curcumin pre-treatment curtailed the expression of pro-inflammatory markers like TNF-α and simultaneously increased the IL-10 expression in renal tissue, whereas, post-treatment of curcumin failed to reduce the expression of pro-inflammatory cytokines completely and on the contrary failed to show a rise in the IL-10 level. Conclusion: Comparative nephrotoxicity studies showed that curcumin pre-treatment protocol is much better nephroprotective when compared with curcumin post-treatment protocol on cisplatin induced nephrotoxicity in rats.

Keywords: Cisplatin; curcumin; cytokine; inflammation; nephrotoxicity


  CPRA (CLINICAL PRACTICE) Top



  CPRA – 1: Pharmacoepidemiology of Poisoning Cases in Paediatric Age Group at a Tertiary Care Teaching Hospital in Odisha Top


Priyadarshi K, Behera JP, Maharana CS

Depertment of Pharmacology, M.K.C.G.Medical College, Brahmapur, Odisha, India

E-mail: [email protected]

Objectives: Poisoning in children is a frequent and preventable cause of morbidity and mortality The aim of this study was to determine the demographic profile, pharmacological interventions and risk factors associated with mortality in pediatric poisoning cases at a tertiary care teaching hospital in Odisha. Materials and Methods: This is a prospective, observational study conducted in the emergency ward of paediatrics department. at M.K.C.G. Medical college and hospital from March 2016 to August 2016. Results: A total of 105 cases were enrolled in this study as per the suitable inclusion and exclusion criteria.57% cases were under 5yrs with males accounting for 67% cases . Majority of cases (84%) were from rural areas and 93% of cases were accidental in nature . Poisoning due to biological agents were maximum (52.3%) with a cure rate of 93% after specific antidote Maximum urban cases presented within 1 hr while rural cases presented within 6 hrs with a cure rate of 98%(p<0.01).Only 56% cases presenting after 6 hrs could be cured. 1 mth to 1 yr age group had maximum mortality (25%) while mortality in rural area was more (6%) compared to urban areas. Conclusion: The trends for paediatric poisoning noted at our centre are not very different from those observed in hospital based studies conducted in other parts of our country. A direct co-relation between time lapsed in reaching hospital and mortality was shown in this study. Consultation with poison information centre would further improve management.

Keywords: Accidental poisoning, mortality, biological agents, time lapse


  CPRA – 2: Influence of Bkc-Free Latanoprost on Ocular Surface Health in Patients of Primary Open - Angle Glaucoma Top


Hema Chhabra, Anita K Gupta, Gursatinder Singh1

Departments of Pharmacology and 1Ophthalmology, Government Medical College, Patiala, Punjab, India

Objective: The purpose of this study was to compare the effect of Benzalkonium-chloride (BKC) preserved latanoprost and Benzalkonium chloride (BKC)-free latanoprost on ocular surface health in patients of primary open angle glaucoma (POAG). Methods: This was a prospective, open-label, randomized, interventional trial. 30 established cases of POAG with intraocular pressure (IOP) controlled on BKC-preserved latanoprost for >3 months were enrolled. Their Schirmer test, Tear film break-up time (TBUT) and IOP were recorded at the baseline. They were required to answer an ocular surface disease index (OSDI) questionnaire from which an OSDI score was calculated. They were switched to BKC-free latanoprost for another three months. On their follow-up visit at 6 weeks and 12 weeks, Schirmer test and TBUT were performed again, IOP was recorded and OSDI score was calculated. Results: Schirmer test increased from (6.73 ± 3.77 mm) at baseline to (9.53 ± 3.67 mm) at 6 weeks and (11.97 ± 3.53 mm) at 12 weeks (p=0.001). Mean TBUT improved significantly from (6.77 ± 3.82 seconds) at baseline to (8.63 ± 3.91 seconds) at 6 weeks to (10.47 ± 3.76 seconds) at 12 weeks (p=0.001). OSDI score decreased from (31.55± 23.32) at baseline to (23.42 ± 21.93) at 6 weeks to (15.82 ± 20.10) at 12 weeks (p=0.001). Among these three parameters, TBUT was found to be the most accurate and reliable indicator of Ocular Surface Disease (OSD)(p=0.000). Mean IOP decreased from (16.3 ± 1.15 mm Hg) at baseline to (15.2 ± 1.13 mm Hg) at 6 weeks and (14.2 ± 1.13 mm Hg) at 12 weeks(p=0.001). Conclusion: BKC-free latanoprost was far better tolerated and equally efficacious as BKC-preserved latanoprost.

Keywords: Benzalkonium chloride, dry eye, glaucoma, latanoprost, ocular surface disease, preservative free


  CPRA – 3: Assessment of Drug Drug Interactions in Patients Receiving Second-Line Antitubercular Drugs in A Tertiary Care Hospital in Eastern India Top


Ansuman Abhisek P, Priti Das, Kali Prasad Pattanaik, Srikanta Mohanty, Geetanjali Panda, Mano Ranjan Pattanaik

SCBMCH, Cuttack, Odisha, India

Aim and Objectives: To assess the prevalence of drug-drug interactions (DDIs) in patients receiving second-line antitubercular drugs, their frequency, severity & to analyse possible mechanisms by applying different softwere programmes.Patients and Methods: This prospective, observational study conducted from January 2016 to June 2016 in Dept. of Pharmacology in collaboration with Dept. of Pulmonary Medicine SCBMCH, Cuttack by analysing the prescriptions of 42 patients receiving second-line antitubercular drugs. DDIs were analyzed using Trial versions of softwares like LEXICOMP, MICROMEDEX and online software like DRUGS.COM, MEDSCAPE.COM drug interaction checker and STOCKLEY drug interaction book.Only interactions of major or moderate severity were included in the potential DDI analysis. Results: Mean age of patients was 33.11 (SD=11.05) years. Patients received 13.02(SD=4.43) drugs during their total hospital stay. Out of total 386 interactions observed, 35.23% were major , 48.70% moderate and 16.06% minor . All patients had at least 1 potential DDI and 92.85% were exposed to at least 1 major potential DDI. Among the risk rating avoid combinations (X) were 6.73% , modify regimen (D) were 11.39% and monitor therapy(C) were 81.86%. Most potential DDIs had moderate severity (48.70%) and the possible mechanism of DDI found was of pharmacodynamic nature (39.89%). Conclusions: Among 386 interactions detected, potential interactions detected were 83.93% among which maximum were of moderate type and of pharmacodynamic nature.

Keywords: Drugs.com, Frecuency, Lexicomp, Medscape, Micromedex, pharmacodynamic, prevalence, risk, severity, stockley


  CPRA – 4: Prospective, Randomized Double Blind Comparative Study of Safety and Efficacy of Carvedilol Versus Atenolol in Patients of Mild to Moderate Hypertension Top


Swathi Ratnam R, Usha Kiran P, Siva Prasad KV, Thirumala Rao MVV1

Departments of Pharmacology and 1Medicine, Rangaraya Medical College, Kakinada, Andhra Pradesh, India

Objectives: To Compare Safety and Efficacy of Carvedilol and Atenolol in patients of essential hypertension by measuring systolic and diastolic blood pressure, heart rate and their adverse effects. Materials and Methods: This prospective study was conducted in the department of medicine of GGH Kakinada for a period 3 years (2012 -2015). A total of 80 patients were enrolled in the study as per the selection criteria. The patients were randomly allocated into two groups. Group A (n=40) received Carvedilol 25mg, Group B (n=40) received Atenolol 50mg Once daily morning dose were treated for 12 weeks. Statistical analysis was done by student t test. Results: The mean reduction of systolic blood pressure with carvedilol is 22.40±8.31 mmHg with No Significant difference (p>0.05) compared to atenolol group mean reduction of 21.37±10 mm Hg. The mean reduction of diastolic blood pressure in carvedilol group is 7.23±4.82mm Hg with No Significant difference (p>0.05) compared to atenolol group mean reduction of 8.55±5.25mm Hg. Mean Heart Rate in group A and group B are 75.12±5.17and 63.55±8.71 respectively, with Significant Difference (p<0.05). In the total study bradycardia is seen in 7.5% in group A and 15% is seen in group B, head ache is seen in 10% patients in group A and 15% in group B. Conclusions: Carvedilol and Atenolol are similar in terms of safety and efficacy with carvedilol having less adverse effects comparatively.

Keywords: Atenolol, carvedilol, hypertension


  CPRA – 5: A Comparison of Tear Substitutes in Dry Eye Due to Computer Vision Syndrome: A Prospective, Open-Label Study Top


Rahul MR, Gagandeep Kwatra, Nitin Batra1

Departments of Pharmacology and 1Ophthalmology, Christian Medical College, Ludhiana, Punjab, India

Objective: To compare the efficacy of carboxymethylcellulose (CMC) 0.5% and hydroxypropyl methylcellulose (HPMC) 0.3% tear substitutes in dry eye due to computer vision syndrome.Methods: This was a prospective, randomized, comparative and open label study conducted in 90 patients with group A(n=45) receiving CMC and Group B(n=45) receiving HPMC tear substitutes 3 times a day. Efficacy of the two tear substitutes were compared using Schirmer-I test and OSDI (Ocular Surface Disease Index) questionnaire on days 15, 30 and 90 after the start of treatment. Appropriate statistical tests were used and p value of <0.05 was considered statistically significant. Results: The median OSDI score at baseline for group A was 22 and for group B was 22.5. Statistically significant improvement from baseline median OSDI score was shown at all follow up visits for group A (19, 16 and 14 respectively, p value <0.001) and group B(20, 10 and 15 respectively, p value<0.001).The median value of Schirmer-I test of group A was 12 and for group B was 13 at baseline. Statistically significant improvement from baseline value of Schirmer –I test was shown at all follow up visits for group A(18,20.5,24.5 respectively, p value <0.001) and group B(16,20,21 respectively, p value<0.001).The percentage improvement in OSDI score and Schirmer –I values at all follow up visits were more with group A compared to group B. Conclusion: Although both tear substitutes reduced the severity of the symptoms in computer vision syndrome, CMC 0.5% was found to be more efficacious.

Keywords: Carboxymethyl cellulose, computer vision syndrome, hydroxypropyl methylcellulose, Ocular Surface Disease Index Questionnaire, tear substitutes


  CPRA – 6: Quality of Life with Omeprazole Versus Omeprazole Plus Sodium Alginate in Extra-Esophageal Reflux Disease: A Randomized Controlled Study. Top


Swetha Reba Mathews, Dinesh Kumar Badyal, Ashish Varghese1

Departments of Pharmacology and 1Otorhinolaryngology, Christian Medical College, Ludhiana, Punjab, India

Introduction: Extra-Esophageal Reflux Disease (EERD), also termed Laryngopharyngeal Reflux Disease (LPRD) or silent reflux, refers to the manifestations of retrograde flow of gastric contents to upper airway and allied extra-esophageal structures. EERD affects social functioning, mainly due to the negative impact on speech and lifestyle. A minimum of six weeks therapy with high dose proton pump inhibitors with or without adjunctive sodium alginate is recommended by AAO-HNS for management of EERD. Objective: To compare the impact of omeprazole versus omeprazole and sodium alginate on quality of life in EERD. Methods: Forty subjects with EERD were randomized into two groups (n=20), to receive capsule omeprazole 40 mg twice daily (group A), or capsule omeprazole 40 mg twice daily with syrup sodium alginate 10ml four times daily (group B), for six weeks. The quality of life of subjects was assessed at baseline and at end of 6 weeks using LPRD-HRQoL instrument. Domain-wise and total scores were analyzed between the groups and within groups using t test. Results: A significant enhancement in quality of life was seen in group B, when compared to group A (P = 0.020). Also, there was a significant improvement in quality of life when compared with baseline in group B (P=0.008). Also the change of LPRD-HRQoL score from baseline was not significant in group A (P=0.136). Conclusion: Treatment with high dose omeprazole and sodium alginate for six weeks, could significantly improve the quality of life in patients with EERD when compared to treatment with omeprazole alone.

Keywords: Extra-esophageal reflux disease, omeprazole in extra-esophageal reflux disease, sodium alginate in extra-esophageal reflux disease


  CPRA – 7: Drug Utilisation Study in Cases of Abnormal Liver Function Tests Admitted in Medicine Department of a Tertiary Care Teaching Hospital Top


Patel IP, Trivedi NA, Gaekwad VL

Department of Pharmacology, Medical College, Baroda, Gujarat, India

E-mail: dr.patel.ishani.gmail.com

Objectives: Liver being a major organ in metabolism and elimination of many drugs, precautions are needed while choosing appropriate drug as well as dosing schedule in patients with abnormal liver function tests (LFT). Our aim was to study prescription pattern in patients with abnormal LFT. Methods: After prior approval from IECHR, prospective observational study was conducted in patients admitted in Medicine Department at a tertiary care teaching hospital from October 2015 to March 2016. All inpatients with abnormal LFT, satisfying inclusion and exclusion criteria were included. Demographic, clinical and pharmacotherapy related details were noted in a pre-structured proforma. Results: Among 260 patients included in the study 77% were male (Mean age 39+14 years). Alcoholic liver disease (45%) and Hepatitis (21%) accounted for most common causes of abnormal LFT. As per Wold Heath Organization (WHO) prescribing indicators, the average number of drugs per encounter was 11. Moreover, percentage of drugs prescribed by generic name, percentage of encounters with an injection, percentage of encounters with an antibiotics and percentage of drugs prescribed from National List of Essential Medicine of India (NLEMI) 2015 were 46, 98, 73.03 and 69.94 respectively. Out of 173 prescribed drugs 55% drugs had hepatic metabolism, while 30% drugs needed precaution or contraindicated. 9% of patients developed ADR which needed either treatment modification or symptomatic treatment. Conclusion: Study of prescription pattern in patients with abnormal LFT needs special attention as here all WHO prescribing indicator showed a deviation from the standard prescribing indicators values.

Keywords: Adverse drug reaction, drug utilization, liver disease


  CPRA – 8: Assessment of Knowledge of Medical Post Graduate Students Regarding Promotional Drug Literature Using Who Criteria Top


Tikam Singh Dhruw, Shikha Jaiswal, Rajesh Hishikar

Department of Pharmacology, Pt. J.N.M. Medical College, Raipur, Chhattisgarh, India

Objective: Pharmaceutical promotional activities create potential for inappropriate prescribing practices without necessarily benefiting the patients but contributes to increased health care costs if prescriber is not aware of WHO criteria for ethical medical drug promotion 1988.So this study was conducted with objective to assess the knowledge of medical post graduate students about WHO criteria for promotional drug literature. Methods: This observational study was conducted in the various departments of Pt. J.N.M.Medical College & associated Dr.B.R.Ambedkar Memorial Hospital Raipur(C.G.) 100 medical post graduate students were given a promotional drug literature & were asked to evaluate it according to WHO Criteria on prescribed proforma. Results: 33% Medical Post Graduate students were aware of WHO criteria. 14% students evaluated importance of reference of scientific literature .29% evaluated importance of name and address of manufacturer or distributor. 33% evaluated necessity of dosage form or regimen.70% evaluated the importance of active ingredients.76% students evaluated the importance of other ingredients or adjuvant known to cause problem. 80% students evaluated the importance of major drug interactions .95% students evaluated the importance of the amount of active ingredients per dosage form.96% students evaluated importance of drug related precautions, contraindications and warnings.98% evaluated the importance of side effects and major adverse drug reactions.100% students evaluated the importance of brand name and approved therapeutic uses. Conclusions: The study showed that medical post graduate students have little knowledge about WHO Criteria of promotional drug literature. They require constant education regarding WHO guidelines as these brochures often influence prescribing behaviours of physicians.

Keywords: Promotional drug literature, students, WHO criteria


  CPRA – 9: Prescription Pattern in Orthopedics Outpatient Department at a Tertiary Care Hospital with Special Reference to Analgesics Top


Chayna Sarkar, Dhriti Kumar Brahma, Julie B Wahlang, Joonmoni Lahon, Banylla Shisha Nongkynrih

North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences

Objective: To analyze the prescribing pattern of analgesics in the Orthopaedics OPD at a tertiary care teaching hospital. Methods: A one-year prospective cross-sectional study was carried out in the Orthopaedics OPD between November 2014- November 2015 and prescriptions were reviewed after taking valid informed consent. No follow up of prescription was done. Results: A total of 238 prescriptions were analyzed. 54.6 % were male and 45.4 % were female. Of the 238 prescriptions there were total 798 drugs prescribed, with an average of 3.3 drugs per prescription. Average number of FDC per prescription accounts for 1.82 (n=446). Out of the total number of drugs, 375 (46.99%) drugs were analgesics; out of which 332 (89.3%) were NSAIDs and 44 (11.7%) were opioid analgesics. The most common analgesic was Aceclofenac (37%) followed by Paracetamol and the least prescribed were Etodolac and Metaxolone. The non analgesics like Gabapentin, Pregabalin and Nortryptyline were also observed to be prescribed commonly. Supportive drugs prescribed were mostly gastroprotective (commonly proton pump inhibitors) and nutritional supplements. Conclusions: Our study revealed that the most commonly prescribed NSAIDs was Aceclofenac either alone or in combination, whereas the most commonly prescribed opiod was Tramadol. Our study is in accordance with the other study that validates Aceclofenac, in everyday clinical practice, as an effective, well-tolerated and well-accepted therapy for both acute and chronic inflammatory and degenerative disease.

Keywords: Nonsteroidal anti-inflammatory drugs, opioids, prescribing pattern


  CHM (CHEMOTHERAPY) Top


[TAG:2]CHM – 1: Comparative Study of the Efficacy and Safety of Topical Anti- Fungal Agents Clotrimazole versus Sertaconazole in the Treatment of Tinea Corporis/Cruris [/TAG:2]

Satish GR, Laxminarayana Kamath

Department of Pharmacology, Bangalore Medical College and Research Institute, Bengaluru, Karnataka, India

Introduction: Tinea corporis is a common dermatophytic infection affecting 22 -25% of world population. Clotrimazole is conventional antifungal drug whereas Sertaconazole is newer antifungal claimed to be superior to clotrimazole. Both are used topically. Objective: To compare the efficacy and safety of topical Clotrimazole vs Sertaconazole in Tinea corporis/cruris Materials and Methods: 60 patients diagnosed with tinea corporis/cruris were randomized into two groups 30 patients each. Group A received topical Clotrimazole (2% cream) and group B received topical Sertaconazole (2% cream). The patients were advised to apply the drug on affected area twice daily for four weeks. Outcome parameters like pruritus, erythema, vesicles and desquamation and KOH mount were noted weekly for the assessment of efficacy. Results: There was significant reduction in pruritus (p<0.0001), erythema (p<0.0001), vesicles (p<0.0001) and desquamation (p<0.001) among both the groups. The mean difference and the standard deviation of total score of all parameters (baseline to fourth week follow up) for Clotrimazole group were 8.2 and 0.751 and for Sertaconazole group were 7.4 and 1.123 respectively. The p-value on application of students unpaired t- test was p<0.115 (not significant). No serious adverse drug events in both the groups. Conclusions: Previous studies have reported topical sertaconazole is more efficacious than clotrimazole. While in our study, we found clotrimazole is as effective as sertaconazole in tinea corporis/cruris with added advantage of cost-effectiveness.

Keywords: Clotrimazole, sertaconazole, tinea corporis/cruris


  CHM – 2: Pattern of Adverse Drug Reaction in Patients Receiving Cancer Chemotherapy in A Tertiary Care Hospital Top


Patel KB, Sukhlecha AG, Trivedi HR

M. P. Shah Government Medical College, Jamnagar, Gujarat, India

E-mail: [email protected]

Objectives: To estimate the incidence of adverse drug reactions in cancer chemotherapy receiving patients. To assess and establish causality based on WHO-UMC and Naranjo scales. Methodology: A prospective, observational study was carried out for duration of 12 months (June 2015 to June 2016). All the patients receiving cancer chemotherapy at Guru Gobindsing Government hospital, Jamnagar during the study period were observed for adverse drug reactions following chemotherapy. Clinical and treatment data were collected from the inpatient case records. CDSCO forms were used to record the ADRs and were reported via VIGIFLOW for further assessment. Causality, severity and preventability were assessed by WHO causality assessment scale and Naranjo scale, Hartwig and Seigel, Schumock and Thornton scale respectively. Results: Total 200 patients were screened for ADR monitoring. Total 107 ADRs were reported of the screened patients. Out of 107 ADRs 55 (51.40%) were seen among males and 52(48.60%) in females. Most common affected organ system was Blood 58 ADRs (54.21%), followed by GIT 25 ADRs (23.36%). According to WHO causality most were possible type 99 (92.50%), followed by probable 7(6.50%) and certain 1 (1%). According to Naranjo most were probable 86 (80.37%), followed by possible 20 (18.63%) and definite 1 (1%). Most common drug implicated In ADRs was Carboplatin 35 (32.71%) followed by Paclitaxel 32 (39.90%). Conclusions: Early detection of drug toxicity helps to treat the patient and modify the doses or the drug regimen to minimize toxic effects since some of the adverse drug reactions are dose dependent.

Keywords: ADR, causality assessment scales, chemotherapy


  CHM – 3: Doxorubicine Induced Dilated Cardiomyopathy in Tertiary Care Centre: a Case Report Top


Keshwala AR, Trivedi HR

Department of Pharmacology,, M P Shah Goverment Medical College,, Jamnagar, Gujarat, India

Doxorubicin, an anthracycline antibiotic used in carcinoma of breast is well known to cause cardiotoxicity. Doxorubicin induced Dilated cardiomyopathy leads to mortality in 50% cases. A case of 64years old female with breast carcinoma was admitted in tertiary care hospital in Radiotherapy department, to whom doxorubicin 70mg/m2 intravenous infusion at 21days interval 5cycle was given. Along with this Cyclophosphamide 975mg and Paclitaxel 260mg IV infusion at 21days interval were given. At the end of third cycle of chemotherapy patient presented with symptoms of overt heart failure. Echocardiography was done and finding suggested dilated cardiomyopathy. The left ventricular ejection fraction was reduced from 57% to 40%. She had no history of cardiac risk factors and laboratory imagining findings suggested myocarditis or dilated cardiomyopathy in past. Echocardiography and differential diagnosis attribute to early onset doxorubicin induced Dilated Cardiomyopathy. According to 'World Health Organization(WHO)causality assessment scale', 'Hartwig and Siegel's Severity score' and 'Schumock and Thornton Preventability scale' it was classified as “Possible”,”severe Adverse Drug Reaction(ADR)” and “Not preventable” respectively.

Keywords: Anthracycline, chemotherapy, dilated cardiomyopathy, doxorubicin


  CHM – 4: Evaluation of Antitumor Activity and Antioxidant Status of Cleome viscosa against Ehrlich Ascites Carcinoma in Swiss Albino Mice Top


Pavan Kumar Samudrala

Objective: The main objective of the present study was to explore the antitumor activity of the chloroform extract of Cleome viscosa (CCV) and its antioxidant status against Ehrlich ascites carcinoma (EAC) in Swiss albino mice. Materials and Methods: Based on the preliminary in vitro cytotoxicity studies, CCV was selected for anti-tumor and antioxidant effects. Anticancer activity of CCV was evaluated against EAC in Swiss albino mice at the doses of 200 and 400mg/kg. CCV was administered for 14 consecutive days after induction of cancer. After 24h of the last dose and 18h of fasting, half of the mice were sacrificed and rest was kept alive for assessing increase in life span. The antitumor effect of CCV was assessed by evaluating tumor volume, viable and nonviable tumor cell count, tumor weight, hematological and biochemical parameters of EAC bearing mice. Furthermore, the antioxidant parameters were evaluated. Results: CCV treatment has shown significant decrease in tumor volume, viable cell count, tumor weight and increases the life span of EAC tumor bearing mice in a dose dependent manner. In hematological profile count of RBC, hemoglobin, and WBC were found reverted to normal. CCV also significantly decreased the levels of lipid peroxidation and significantly increased the levels of GSH, SOD and Catalase. Conclusion: From the above results it may be concluded that CCV has potent dose dependent antitumor activity and is comparable to that of 5-flourouracil.


  CHM – 5: Study on Patterns of Adverse Drug Reactions Among Patient's Receiving Anticancer Drugs in A Tertiary Care Hospital In South India Top


Shovan Padhy, Usharani P, Sadhasivudu G1

Departments of Clinical Pharmacology and Therapeutics and 1Oncology, Nizam's Institute of Medical Sciences, Hyderabad, Telangana, India

Background: Adverse Drug Reactions (ADRs) is a leading cause of morbidity & mortality seen with the use of anticancer drugs. It imposes considerable economic burden in patients. Pharmacovigilance plays an integral role in monitoring, detecting & preventing these reactions. Objective: The aim of this study is to evaluate the patterns of ADRs with anticancer drugs and to establish a causal relationship. Methods: Spontaneous ADRs reporting forms under PvPI were collected.ADRs reported from the department of oncology over a period of six months was analyzed. Data regarding the nature of ADRs reported, and a causal relationship was established. Results: A total of 53 different types of ADRs were reported. Majority of the ADRs reported belonged to the age group between 51 to 60 years of age .The mean age of the patients was 55.78+2.3 years. Most of the ADRs were reported in male (55.9%) as compared to female (45.2%) patients.Lymphoma (19.6%) and Breast carcinoma (21.8%)were most common conditions among male and female patients respectively who received chemotherapy.Cutaneous adverse drug reactions (22.4%) were the most commonly reported. It included ADRs of erythematous rash, hypopigmented macules,dermatitis and steven johnson's syndrome/TEN.Other ADRs reported were vomiting (19.6%),febrile neutropaenia (18.4%),alopecia (15.3%),peripheral neuropathy(11.2%),bronchospasm(1%) and chestpain(1%).The most suspected drugs were cisplatin(28.4%), 5F.U(25.1%),followed by vincristine(19.1%),tyrosine kinase inhibitors(14.6%) and rituximab(8.2%).WHO causality assessment scale showed that observed ADRs were of probable(57%) and possible(43%) categories. Conclusion: Our study provided data regarding safety profile of anticancer drugs.Pharmacogenetic variability can be a factor for these ADRs.Future pharmacogenomics studies can help in minimising such reactions.

Keywords: Adverse drug reactions, anticancer drug, causality


  CHM – 6: Comparitive Study of Chemotherapy with and without Adjuvant Radiotherapy in Stage II, III Breast Cancer Patients Top


Anjana Mohan, Ponnusankar S1, Balasubramaniam V2

St.Thomas Hospital, Chengannur, Kerala, 1J.S.S College of Pharmacy, 2Government Headquarters Hospital, Ooty, Tamil Nadu, India

Background: Breast Cancer is found to have better prognosis when radiotherapy is either given as neoadjuvant or adjuvant chemotherapy. The concomitant chemotherapy and radiation is effective in the arresting of tumor growth, improved disease free survival and overall survival rate. Methods: This prospective study included 24 patients with 11 patients in FAC regimen and 13 in FAC with radiotherapy. The inclusion criteria were no metastasis, no prior chemotherapy or radiotherapy, adequate basic parameters, adequate ventricular ejection fraction. Exclusion criteria included stage 1 breast cancer. 50 Gy was the total radiation dose given in 25 fractions. Kaplan-Meier analysis was done to compare overall survival in two treatment groups. Log rank tests assess the difference in overall survival. Cox proportional hazard model determine hazard ratio. Fishers analysis indicated the relationship between the treatment groups and failure (loco regional recurrence failure, distant metastasis). Results: The loco regional recurrence rate was 73 % in patients who didn't receive the radiotherapy and nil in the group which received adjuvant radiotherapy. Log rank test Cox proportional hazard analysis was not significant with p value 0.277 and 0.735 respectively. Fishers test showed significant result with p=0.000. Conclusions: The log rank test indicates that overall survival time distribution within the groups was not significant. The hazard ratio in the Cox analysis is >1(HR=1.281) denotes that the impact of cancer stages had some effect on the survival time but was not significant. Fishers analysis indicates the treatment regimen have significant effect on the failure of the therapy thereby corroborating the efficacy of radiotherapy


  CHM – 7: Patient-Derived Cell Lines as a Model for Advancement of Personalized Cancer Therapy Top


Madhuri Acharjya, Prasanta Kumar Nayak, Manini Acharjya1, Gourab Sarkar1

Department of Pharmaceutics, Indian Institute of Technology (Banaras Hindu University), Varanasi, Uttar Pradesh, 1Department of Pharmaceutical Sciences, Utkal University, Bhubaneswar, Odisha, India

Cancer is the second most common killer worldwide and become a global menace. India records maximum mortality due to cancer every year. Despite of advancement in treatment strategies, the observed mortality is due to lack of potential biomarkers and efficacious therapies. Biomarkers play a vital role in the diagnosis as well as management of cancer. Personalized approach is looked-for because of individual variations in response to a therapy. However, there are frequent challenges comprise of tumor heterogeneity and molecular fruition,costs and potential morbidity of biopsies that need to be bettered before conveying the promise of personalized therapy.Microarray,RTPCR,GWAS,SNP array, the current radical technologies for cancer.Whereas cell lines serve as models to study molecular mechanisms of cancer and a provision for anticancer drug development but it is limited so far. Hence Cancer cells acquired from biopsies or circulating tumor cells of patients provides a screening platform with specific tumor characteristics. The patient-derived cell lines support personalized treatment strategies and development of novel anticancer therapeutics for a population of patient with similar tumor characteristics. The same platform may also boost translation of lead compounds into the clinical settings due to clinically relevant drug properties. Conventional cancer cell lines are cheap, grow easily in cultures, and provide high-throughput testing. The patient-derived cells though share all the advantages but pose risks in loss of tumor properties in an unsuitable culture conditions. Therefore, optimization of cell culture conditions remains a key challenge to allow a larger number of patients to benefit from personalized treatment strategies.

Keywords: Conventional cancer cell lines, patient-derived cell lines, personalized medicine, potential biomarkers, tumor characteristics


  CHM – 8: Taxifolin Binds with LXR (α & β) to Remodel DMBA-Induced Mammary Carcinogenesis in Sd-Rats Top


Shakti P Pattanayak, Wasim Ul Haque, Mohd. Usman1, Priyashree Sunita2

Department of Pharmaceutical Sciences and Technology, Division of Advanced Pharmacology, Birla Institute of Technology, 1Department of Pharmaceutical Sciences and Technology, Division of Pharmaceutical Chemistry, Birla Institute of Technology, 2Department of Health, Education and Family Welfair, Government Pharmacy Institute, Government of Jharkhand, Ranchi, Jharkhand, India

E-mail: [email protected]

Objective: 7,12-dimethylbenz(a)anthracene(DMBA), a PAH derivative initialize cascades of signaling events that alters a variety of enzymes involved in lipid and glucose homeostasis resulting in enhanced availability and consumption of energy producing molecules for the development of Carcinogenesis. 3-hydroxy-3-methylglutaryl-coenzyme A reductase (HMG-CoAR) is key enzyme regulating the cholesterol synthesis pathway whereas liver X receptor (LXR) regulates lipid, carbohydrate metabolism in various malignancies including mammary cancer. In this study Taxifolin (TAX), a potential flavanoid has been subjected to evaluate its anti-cancer potential on Mammary-carcinogenesis (MC). Methods: we designed to screen the molecular docking analysis of TAX on LXRα, LXRβ & HMG-CoAR using MAESTRO tool comparing with their reference ligands followed by its evaluation on DMBA-induced MC. Results: The docking analysis revealed significant interaction with LXR (α&β) & HMG-CoAR. The docking results were validated with the enzyme inhibition assay using HMG-CoAR (EC 1.1.1.34). TAX inhibited the HMG-CoAR activity with an IC50 value of 97.54±2.5nM whereas the reference molecule simvastatin revealed an IC50 value of 84.35±1.2nM. Moreover, TAX modulated the energy regulation on DMBA-induced MC in SD-rats by significantly restoring the cancer-induced alterations in body weight, tumor growth and lipid, lipoproteins, LMEs, glycolytic enzymes. TAX interacted with LXRs, HMG-CoAR, metabolic enzymes and restored the altered metabolism that accelerates uncontrolled cell proliferation in MC. Moreover, TAX also altered the mRNA and protein expressions of HMG-CoAR, the protein expression of LXR (α,β). TAX also significantly (p<0.001) reduced the expression of p-Akt by interacting the experessions of LXR (α&β). Conclusions: These results validate the anti-cancer poteial of TAX in DMBA-induced MC.

Keywords: 3-hydroxy-3-methylglutaryl-coenzyme A reductase, 7,12-dimethylbenz(a)anthracene, liver X receptor (α and β), taxifolin


  CHM – 9: In vitro and In vivo Evaluation of Anti-Oxidant and Anti-Cancer Activity of β-Asarone Top


Swastika Maity, Kanchanpreet Kaur, Ujjwal, Pai KSR

Department of Pharmacology, Manipal College of Pharmaceutical Sciences, Manipal, Karnataka, India

E-mail: [email protected]

Objective: To evaluate the anti-oxidant and anti-cancer property of β-asarone using DPPH assay and MTT assay in vitro and MNU-induced breast cancer model in vivo. Materials and MethodS: Investigational lead molecule used in the experiment was cis-2, 4, 5-trimethoxy-1-propenyl benzene (β-asarone). In vitro cytotoxic screening in human cancer cell lines (MCF-7 and HCT116) using MTT assay was performed. In-vitro anti-oxidant assay was performed by DPPH assay. In NMU-induced breast cancer model using SD rats, tumour volume was measured to test the anti-cancer activity of the molecule. Spleen, organ, kidney and liver index were also monitored to identify any possible ADR whereas haematological and biochemical parameters were determined to identify any adverse effect of the molecule in vivo. Results: IC50values by MTT assay for β-asarone against MCF-7 and HCT116 was found to be 202.3 and 221.8 μm, respectively. IC50 values of β-asarone for antioxidant activity by DPPH assay was observed to be 1.2 mM. The molecule showed significant decrease in tumour volume compared to NMU control. The activity of β-asarone was comparable to the standard (doxorubicin) on the 12th day of dosing till the termination of the study on Day 21. Organ, spleen, kidney and liver index were normalized due to treatment whereas no changes were observed in the haematological and biochemical profile which reveals the safety of the molecule. Conclusions: β-asarone shows significant anti-cancer potential in vitro and in vivo with minimal toxicity but lacks anti-oxidant activity.

[TAG:2]CHM – 10: CSF Distribution of High Dose Versus Standard Dose Erlotinib in Lung Cancer Patients with Brain Metastases [/TAG:2]

Naik M, Shriyan B, Doshi K, Nookala M, Gota V, Joshi A1, Noronha V1, Prabhash K1

Department of Clinical Pharmacology, Advanced Centre for Treatment, Research and Education in Cancer, 1Department of Medical Oncology, Tata memorial Hospital, Mumbai, Maharashtra, India

Background: One-third of patients with non small cell lung cancer (NSCLC) develop brain metastasis after initial response to EGFR TKIs. It has been seen that CNS metastases retain EGFR TKIs sensitivity if sufficient drug concentration can be achieved in the cerebrospinal fluid (CSF). Case reports suggest that pulsatile high dose erlotinib (PHDE) can be safe and effective in patients with brain metastasis who progressed on standard dose of erlotinib. The aim of our study was to evaluate the feasibility of PHDE in brain metastasis patients with NSCLC. Methods: 7 patients with brain/leptomeningeal metastases who had progressed on standard dose erlotinib and were prescribed pulsatile high dose were enrolled in this trial. Paired blood and CSF samples were collected on Day 7 and Day 15 following 1 week of treatment with SDE (150 mg per day) and PHDE (1500 mg per week) respectively. 4 hours post dose Plasma and CSF levels of erlotinib were analyzed using a validated LC/MS/MS method. Data was analyzed descriptively. Results: Nine patients of NSCLC with brain metastasis were enrolled. Mean plasma concentration following SDE and PHDE was 3456.37 and 6407.96 ng/ml respectively and the corresponding CSF concentrations were 73.91 and 141.22 ng/ml respectively. Penetration rate was 2.44% and 2.1% for SDE and PHDE respectively. Conclusion: PHDE achieved a high CSF concentration but was poorly tolerated. An optimal dosing strategy would be to scale down the pulsatile dose to achieve a therapeutic CSF concentration without risking the side effects.

Keywords: Brain metastasis, erlotinib, nonsmall cell lung cancer


  PK (PHARMACOKINETICS) Top



  PK – 1: Variability in Serum Tacrolimus Levels in Post Renal Transplant Patients of a Tertiary Care Hospital of Eastern India Top


Shouvik Choudhury, Suparna Chatterjee, Arpita Ray Chaudhury1, Sanjay Dasgupta1

Departments of Pharmacology and 1Nephrology, IPGMER and SSKM Hospital, Kolkata, West Bengal, India

E-mail: [email protected]

Objectives: Tacrolimus is a widely used immunosuppressant drug with narrow therapeutic index. However, it shows high pharmacokinetic variability, necessitating TDM in post renal transplant patients. This observational study was undertaken to analyse serial serum tacrolimus levels and assess whether they were within the desired therapeutic range (9 to 12ng/ml) in the first 6 months post-transplant. Materials and Methods: Patients who had undergone renal transplant in this hospital from January to December 2015 were enrolled. Demographic profile, transplant details, tacrolimus dose, concomitant immunosuppressant intake and other comorbidities were noted. Trough tacrolimus levels were estimated by MEIA (Microparticle Enzyme Immunoassay) technique at 3, 7-10, 21-40 days; 2-3 and 4-6 months' post-transplant. Results: 30 patients were enrolled with a mean age (32 ±10) yr, mean starting oral daily dose of 0.09 mg/kg. Target drug level was out of range in 33.33% (95% CI 17.97 to 53.29%) at 2- 3 months; 37.5% (95% CI 18.48 to 61.36%) at 4-6 months. Serum tacrolimus level based dose titration was undertaken in 8 out of 17 patients with out of range trough levels. All patients were on immediate release tacrolimus formulations and on concomitant mycophenolate mofetil and prednisolone. Conclusions: Variability in trough tacrolimus levels was observed in significant number of patients though they received similar dosing strategy. In addition to drug related factors other confounders may also influence drug levels. This pilot study is part of a population PK modelling study which will provide us further insights into the predicted PK variables of tacrolimus.

Keywords: Drug level, renal transplant, tacrolimus, therapeutic drug monitoring

[TAG:2]PK – 2: Comparative Pharmacokinetics of Ceftizoxime in Sheep and Goats after Intramuscular Administration [/TAG:2]

Mody SK, Patel HA, Bhatiya SI, Patel HB, Singh RD

Department of Pharmacology and Toxicology, College of Veterinary Science and Animal Husbandry, Sardarkrushinagar Dantiwada Agricultural University, Palanpur, Gujarat, India

Ceftizoxime is the broad-spectrum parenteral antibacterial drug used in veterinary medicine. It is a third-generation cephalosporin characterized by its low toxicity and stability to β-lactamases and has potential clinical use in treating bacterial infections of small ruminants. Thus, the present investigation carried out to compare pharmacokinetic behaviour of ceftizoxime in sheep and goats following single dose intramuscular administration at the dose rate of 10 mg/kg body weight. A total of ten adult animals (five goats and five sheep) aged between 24–48 months old and weighing more than 25 kg, were included in this study. The analysis of plasma ceftizoxime concentration was assayed using UHPLC with UV detector and pharmacokinetic data were generated using PK solver software. The mean peak plasma concentration after single intramuscular administration of ceftizoxime at dose rate of 10 mg/kg b. wt. was noticed higher in sheep as 30.48 μg/ml than in goats as 25.60 μg/ml (both at 15 min.). However, drug was detected in plasma of sheep up to 36 h only (0.32 ± 0.03 μg/ml) whereas in goats it was detected up to 48 h (0.29 ± 0.01 μg/ml). Mean values of elimination rate constant (0.07 vs. 0.05 h-1) and area under curve (150.92 vs 101.42 mg.h.ml-1) were found higher in sheep whereas, values of elimination half-life (10.06 vs 14.94 h) and total body clearance (0.07 vs 0.11 L.h-1.Kg-1) were found higher in goats. Apparent volume of distribution (0.69 vs 0.67 L.Kg-1) was almost similar in both the species.


  PK – 3: Pharmacokinetic Investigation of Controlled Release Formulation of Milnacipran Hydrochloride in Rabbits Top


Gautam Singhvi, Sri Raviteja Nalla, Nirav Patel, Niyati Parmar

Department of Pharmacy, Birla Institute of Technology and Science, Pilani, Rajasthan, India

E-mail: [email protected]

Objective: Milnacipran Hydrochloride (MH) is a selective serotonin and norepinephrine dual reuptake inhibitor used for the treatment of depression and fibromylagia . The aim of the present study was to investigate pharmacokinetic parameters of in-house designed polymeric controlled release (CR) tablets of MH in rabbit animal model and study the correlation of in-vitro MH release with in-vivo release. Methods: Controlled release MH tablets were prepared with various proportion of hydrophlic and hydrophobic polymers and characterized for physicochemical characterization. Formulation with desire drug release was selected for pharmacokinetic study. MH tablets were administered orally to rabbits. Blood samples were collected at predetermined time intervals from marginal ear vein and processed for sample analysis. Immediate release (IR) tablets of MH were also prepared without polymer and administered to rabbits for comparative pharmacokinetic study. Results: All the formulation batches were found to be acceptable as per pharmacopeia limits of CR tablets. In-vivo investigation of selected milnacipran CR tablets (F-4) in rabbits showed prolong-release pharmacokinetic profile. The mean Cmax value IR tablets and for CR tablets were found to be 1210.25 ± 20.28 and 601.28 ± 75.36 ng/ml, respectively. Furthermore, the mean residence time (MRT) was prolonged from 3.08 ± 0.35 h, with IR tablets, to 10.97 ± 0.42 h for CR tablets. The mean AUC values for IR tablets and the CR formulation were found to be 4587.63 and 9260.19 ng.h/ml respectively. In conclusion, this extended lower MH plasma level was expected to reduce the intensity of side effects commonly associated with the immediate release tablets.

Keywords: Controlled release, milnacipran hydrochloride, pharmacokinetic


  NEU (NEUROPHARMACOLOGY) Top



  NEU – 1: A Comparitive Study of Efficacy and Safety of IV Valproate and IV Phenytoin in Acute Childhood Seizures Top


Suresh K, Usha Kiran P, Surendra G, Manikyamba

Departments of 1Pharmacology and 2Paediatrics, Rangaraya Medical College, Kakinada, Andhra Pradesh, India

Objectives: To assess the efficacy and safety of IV Valproate and IV Phenytoin in acute childhood seizures. Materials and Methods: It is a prospective study on total of 116 children of age group 3-10 years with generalized seizures. They were randomized to receive IV Valproate 20mg/kg and IV Phenytoin 20mg/kg who already received diazepam at the time of presentation with seizures. The efficacy & safety is measured based on recurrence of seizure within 24hrs duration, adverse events and vital parameters like BP, PR, RR, SpO2. Results: Out of 52 children in valproate group the efficacy was 98% and Out of 55 children in phenytoin group the efficacy was 94%.Total adverse events (Rash, Hypotension, Respiratory depression, Mild SGPT elevation) observed are 3(5.76%) with valproate and 7(12.72%) with phenytoin respectively. Changes in vital parameters are not statistically significant (p>0.05). Conclusions: As percentage of children with recurrence of seizure is less and total adverse events are less with valproate, it is considered to be safe and effective. So it may be included in the treatment protocol as first line drug.

Keywords: Children, generalized seizures, intravenous, phenytoin, valproate


  NEU – 2: Carvedilol Prevents Functional Deficits in Peripheral Nerve Mitochondria in Rats with Oxaliplatin-Evoked Painful Peripheral Neuropathy Top


Aparna.A, Prashanth K, Karthika N, Ashutosh Kumar

Department of Pharmacology and Toxicology, National Institute of Pharmaceutical Education and Research, NIPER, Hyderabad, Telangana, India

E-mail: [email protected]

Objectives: Oxaliplatin is a chemotherapeutic agent characterized by peripheral neuropathy which hampers its usage. Evidence suggests that neurotoxic effect is due to oxidative stress and mitochondrial dysfunction in peripheral nerves and dorsal root ganglion (DRG). Carvedilol is an antihypertensive drug, proved for its antioxidant, mitoprotective and neuroprotective properties. We aimed to study the effect of carvedilol on the function of peripheral nerve mitochondria in the experimental model of oxaliplatin-induced peripheral neuropathy (OIPN). Materials and Methods: Carvedilol at a dose 10 mg/kg p.o. was administered for 4 weeks daily in oxaliplatin (4 mg/kg twice weekly for 4 weeks, i.p.) induced neuropathic rats. Functional and behavioural deficits were assessed by nerve conduction velocity, hyperalgesia and allodynia. Sciatic nerve and DRG were collected to assess the levels of oxidative stress, mitochondrial function, immunohistochemical and western blotting analysis. Neuroprotective effect was compared with a standard antioxidant, α-lipoic acid (100 mg/kg, i.g.). Results: Oxaliplatin significantly (p < 0.001) reduced the sensory nerve conduction velocity and produced the thermal and mechanical nociception. Carvedilol treatment prevented these oxaliplatin-induced deficits and counteracted the lipid peroxidation and nitrosative stress. It also improved the mitochondrial function; restored membrane potential thus prevented apoptosis. The levels of nitrotyrosine were reduced and increased the MnSOD expression in both sciatic nerve and DRG tissues. Carvedilol produced a similar effect to that of α-lipoic acid and no significant changes were observed in alone treated (10 mg/kg p.o.) rats when compared to normal rats. Conclusions: Carvedilol association with oxaliplatin treatment was suggested as a possible strategy to prevent the OIPN.

Keywords: Carvedilol, mitochondrial dysfunction, oxaliplatin, peripheral neuropathy and dorsal root ganglion


  NEU- 3: Study to Determine Efficacy of Flax Seed (Linum usitatissimum) oil Alone and as an Adjuvant with Phenytoin in Maximal Electroshock Induced Seizures in Albino Rats Top


Rahul H Damodar, Suneel Kumar Reddy, Malvika Goyal, Pradeep BE, Shashikala GH

Department of Pharmacology, JJMMC, Davangere, Karnataka, India

Objective: To evaluate the anticonvulsant activity of flax seed oil alone and as an adjuvant to Phenytoin Sodium. Methods: A total of 24 rats were divided into four groups of 6 rats each-Control, Standard (Phenytoin sodium 25mg/kg), Test I (flax seed oil 1.8ml/kg) and Test II (Flax seed oil 1.8ml/kg along with Phenytoin 25mg/kg). Maximal Electroshock Seizures (MES,60-Hz AC of 150 mA intensity for 0.2 seconds) were induced using an electro convulsiometer with ear electrodes, 60 mins after oral drug administration. Duration of tonic hind limb extension (THLE) was used to assess anticonvulsant activity of the drug. Results: The mean duration of THLE (in seconds) in 4 groups were 11.66 (Control), 5.67 (Standard), 3.85 (Test I) and 2.69 (Test II). Duration of THLE was reduced in flax seed oil group (P <0.000) compared to both control and standard. Other parameters like time taken to regain righting reflex and recovery time were also reduced. Flax seed oil with phenytoin group showed significant anti-convulsant activity and reduction in other parameters observed were greater than either drug alone. Conclusions: The study showed flax seed oil possesses marked anti-convulsant activity in MES model both when used alone and as an adjuvant to phenytoin and hence flax seed oil can have antiepileptic activity in generalized tonic clonic seizure.

Keywords: Anti-convulsant, flax seed oil, maximal electroshock seizure, tonic hind limb extension


  NEU- 4: A Comparative Study of the Antidepressant Effect of Ondansetron and Granisetron on Albino Mice. Top


Mansi J Shah, Geetha M, Shilpa BN, Shashikala GH

Department of Pharmacology, JJMMC, Davangere, Karnataka, India

Objective: Conventional antidepressants possess affinity for Histaminic,Dopaminergic, Opioid and 5-HT receptors , which are responsible for side effects like sedation.nausea.mood swings etc. Highly selective 5-HT3 receptor antagonists like Granisetron and Ondensetron have no affinity for these receptors, a characteristic that is thought to have favourable safety profile. This study was hence undertaken to Compare the antidepressant activities of Ondensetron and Granisetron using Rodent behavioural model of depression . Methods: After necessary approval from Institutional Animal ethics Committee(IAEC) 24 albino mice ,weighing 25-30gm of either sex were randomly alloted into 4 groups of 6 mice each. Depression was induced by keeping each animal in isolation for 48hrs prior to study.Group1(control) received normal saline 10ml/kg, Group 2(standard) received Fluoxetine 10mg/kg,Group3 (test drug 1)received Ondensetron 2mg/kg and Group 4(test drug 2) received Granisetron 0.5mg/kg. Antidepressant activity was evaluated after 60 minutes of intraperitoneal drug administration using Forced swim test(FST) and Tail suspension test(TST) in which duration of immobility time for each mouse in 6min was recorded .All the observations were analysed using ANOVA(one way)with post hoc tukeys HSD. Results: Granisetron produced significant (p<0.001) reduction in the duration of immobility in both FST and TST when compared to Ondensetron and Fluoxetien. When compared to Fluoxetien , Ondensetron showed significant reduction(p<0.001) in immobility time in TST model. Conclusions: This Study Suggested Granisetron Possessed better Antidepressant Effect when compared to Ondensetron and standard Fluoxetien .Since Granisetron has better safety profile then the standard antidepressant drug and it has longer plasma half life then Ondensetron, Granisetron could be of therapeutic interest for treatment of depressive disorders.

Keywords: Antidepressant, granisetron, ondensetron


  NEU- 5: Drug Induced Extra Pyramidal Symptoms in Psychosis Not Otherwise Specified Top


Ahamed J, Jangir RK, Ali A, Kumar J, Swami NK, Singh J

Department of Pharmacology, Dr. S. N. Medical College, Jodhpur, Rajasthan, India

Objectives: Extra Pyramidal Symptoms(EPS) also known as Extra Pyramidal side effects, commonly occure as , drug induced movement disorders that include acute and tardive symptoms. Various symptoms could be: Dystonia- Continous spasm and muscle contractions; Akathisia- Motor restlessness;  Parkinsonism More Details-Characteristic symptoms such as rigidity; Bradykinesia-Slowness of movement and Tardive Dyskinesia-Irregular jerky movements. Anti psychotic drugs often cause extra pyramidal symptoms. Commonly used medication for extra pyramidal symptoms are centrally acting anticholinergic drugs, viz. Benztropine, Diphenhydramine, Trihexyphenidyl and Dopamine agonistic agents like Pramipexole. Materials and Methods: Case Presentation- A 55 year old patient was admitted in male psychiatric ward on 28/05/16 with diagnosis of Psychosis NOS(NOT Otherwise Specified). Treatment was started on same day as -(1) Tab Trifluperazine 5 mg TDS (2) Tab Risperidone 2 mg BD (3) Tab Alprazolam 0.5 mg TDS and (4) Inj B complex (B1,B6,B12) IM stat. On next day patient has developed extra pyramidal symptoms like muscular contraction of jaw neck and tremors in hands. Laboratory investigation: Extra pyramidal symptoms were diagnosed by clinical examinations. Laboratory findings-Hb 10.8 gm% ECG and Chest x-ray were within normal limits. Drug essay was not done. Results: Extra pyramidal symptoms were started due to Anti psychotic drug Tab Trifluperazine. On the next day it was withdrawn and Anticholinergic drug Tab Trihexyphenidyl was started. Conclusions: Antipsychotic drug like Trifluperazine has produced extra pyramidal symptoms and patient's condition was improved after withdrawal of it and simultaneously anticholinergic drug Trihexyphenidyl was started.

Keywords: Extra pyramidal symptoms, not otherwise specified, trifluperazine, trihexyphenidyl


  NEU – 6: Effect of Anti-Epileptic Drugs on Cognitive functions: a Prospective Study in Individuals with Newly Diagnosed Complex Partial Seizure and Generalized Tonic Clonic Seizure Top


Jayant Rai, Aashal Shah, Preeti P Yadav, Asif Barejia, Vipul M Navadiya, Dharna Patel

Department of Pharmacology, Government Medical College, Surat, Gujarat, India

Objectives: Epilepsy, the third most common neurologic disorder, deteriorates cognitive functions of the patients. Opinions regarding impact of anti-epileptic drugs, which are the mainstay of epilepsy treatment, on cognition are divided. So, this study was designed to assess the impact of Anti-epileptic drugs on Cognitive performance of patients with Complex Partial Seizure and Generalized Tonic Clonic Seizure in Department of Medicine, at New Civil Hospital Surat, Gujarat, India. Methodology: In a non-interventional, prospective, observational cohort study cognitive functions were assessed in 50 Patients of Newly diagnosed Complex Partial Seizure & Generalized Tonic Clonic Seizure coming to New Civil Hospital Surat. The cognitive functions were evaluated by Addenbrooke's Cognitive Examination (ACE)-III, which assessed memory, attention, fluency, language & visuo-spatial abilities. ACE-III is a globally accepted cognitive test. ACE-III was done to take baseline & follow-up score. Follow-up was done after six months of baseline. Results: Baseline and Follow-up data from 50 patients were included. Patient treated with anti-epileptic drugs showed significant improvement in memory, attention, language & visuo-spatial abilities whereas improvement in fluency was not significant. Paired t-test and Wilcoxon Signed Ranks Test were used to analyse the data. Conclusions: The available data indicate that the anti-epileptic drugs do not adversely affect cognitive function in patients with newly diagnosed CPS & GTCS. The study concludes that the Anti-epileptic drugs improve cognition in patients of CPS & GTCS. Importantly, the data suggest that the effects exerted by AEDs could depend on factors linked to patient characteristics and individual susceptibility and to comment on those factors further studies are needed.

Keywords: Addenbrookes Cognitive Examination-III, anti-epileptic drugs, cognition, CPS, epilepsy, GTCS


  NEU – 7: A Comparative Study of Efficacy of Blonanserin Versus Risperidone in Schizophrenia Top


Swati Choudhary, Dinesh Kumar Badyal, Sandeep Kumar Goyal1

Departments of Pharmacology and 1Psychiatry, Christian Medical College and Hospital, Ludhiana, Punjab, India

Objective: To compare the efficacy of blonanserin with risperidonein Schizophrenia. Materials and Methods: 21Patients diagnosed with Schizophrenia (ICD10), with a positive and negative syndrome scale (PANSS) score ≥40 were divided randomly into two treatment groups, Group A received blonanserin 8-24 mg/day, Group Breceived risperidone 2-8mg/day. Patients were assessed at baseline and 3 weeks for clinical efficacy using PANSS Score. Total positive score(TPS), Total negative score (TNS), PANSS score was compared within the groups and amongst the groups. Results: There was statistically significant improvement in intragroup comparison in both groups. The pans score improved by-18.59 % within Group Aand -15.01% within Group B. But no statistically significant difference was seen when the percentage change in PANSS score was compared between Group A and Group B. Conclusions: Both blonanserin and resperidone are efficacious in the Schizophrenia, but there is no significant difference in the efficacy of both the drugs.

Keywords: Blonanserin, efficacy, risperidone, schizophrenia


  NEU – 8: To Study the Antidepressant Activity of Folic Acid and Vitamin-D on Reserpine Induced Depression in Mice Top


Borah L, Lahkar M, Dasgupta S

Gauhati Medical College, Guwahati, Assam, India

Objectives: Considering that depression is found to be associated with low levels of both Folic acid and Vitamin D, this study aims to evaluate the antidepressant effect of low dose and high dose of Folic acid, Vitamin D and a combination of Folic acid and Vitamin D. Materials and Methods: A total of 54 animals were taken and divided into nine groups. Depression was induced by administration of Reserpine i.p. from Day 1-3. Folic acid p.o. (10mg/kg, 50 mg/kg) and Vitamin D3 i.p. (0.2μg/kg, 5μg/kg) were administered from Day 7-20. The animals from all the groups were tested on Forced Swim Test, Tail Suspension Test and Open Field Test. Results: Both Folic acid and Vitamin D were found to have significant antidepressant activity. High dose of Folic acid and Vitamin D were found to have better antidepressant effect compared to low doses of Folic acid and Vitamin D. Combination of Folic acid and Vitamin D was also found to be better than monotherapy with either Folic acid or Vitamin D in amelioration of Reserpine induced depression. Conclusions: Both Folic acid and Vitamin D have a potential role in the treatment of depression.

Keywords: Antidepressant, folic acid, Vitamin D


  NEU- 9: Perillyl Alcohol Ameliorated Restraint Stress-Induced Nerobehavioral Deficits in Mice: Prevention of Neuroinflammatory Cascade in the Hippocampus Top


Mohit Kwatra1, Ashok Jangra1, Sngithiang Mawnai1, Tavleen Singh1, Mangala Lahkar1,2

1Department of Pharmacology and Toxicology, National Institute of Pharmaceutical Education and Research, 2Department of Pharmacology, Gauhati Medical College, Guwahati, Assam, India

E-mail: [email protected]

Objectives: The aim of the study to evaluate the neuroprotective effect of perillyl alcohol in restraint stress induced neurobehavioral and neurochemical anomalies in the mice hippocampus. Materials and Methods: Adult male swiss albino mice (22-25 g) were restraint 6 h/day for 28 days and orally administered (p.o.) with perillyl alcohol (100 and 200 mg/kg) for last 14 days. Open field test (OFT), Elevated plus maze (EPM) was performed to evaluate anxiety-like behavior. Moreover, Forced swimming test (FST), and Morris water maze (MWM) test were performed to assess the depressive-like behavior and cognitive impairment respectively. Furthermore, we have assessed oxido-nitrosative stress parameters in mice hippocampus. The reverse transcriptase PCR was performed to estimate the gene expression level of neuro-inflammatory mediators. Results: Restraint stress group showed anxiety and depressive-like behaviour. Moreover, MWM test revealed the cognitive deficits in restraint stress mice. Restraint stress significantly increased the MDA and nitrite level, and reduced the GSH level in the hippocampus which indicates involvement of oxido-nitrosative stress. Gene expression levels of inflammatory markers, NF-κB, iNOS and COX-2 were found significantly up-regulated. In addition, brain derived neurotrophic factor (BDNF) was found down-regulated in the hippocampus of stressed mice. Perillyl alcohol (200 mg/kg) treatment significantly ameliorated neuobehavioural and neurochemical deficits induced by restraint stress. Conclusions: Our results suggested that inflammatory cascade activated in the hippocampus may be the partly contributor for the stress-induced neurobehavioural deficits. The Perillyl alcohol could be a novel approach for the treatment of anxiety, depression and cognitive disorders.

Keywords: Inflammation, oxido-nitrosative stress, perillyl alcohol


  NEU – 10: To Compare Efficacy of Olanzapine, Risperidone and Quetiapine in Newly Diagnosed Patients of Schizophrenia at myh Hospital Indore Top


Gopal Gudsurkar, Pooja Solanki1, Ramgulam Razdan2, Pali Rastogi1, Shubham Atal2

Departments of 1Pharmacology and 2Pharmacology, MGM Medical College, Indore, Madhya Pradesh, India

Objective: Schizophrenia is a psychiatric disorder characterized by hallucinations and delusions. Second generation antipsychotics (SGA's) are now widely used for treatment of schizophrenia. As there are no clear guidelines for treatment of schizophrenia, our study aimed at comparing efficacy of olanzapine, risperidone and quetiapine in newly diagnosed cases of schizophrenia at Psychiatry OPD of MYH hospital Indore. Material and Methods: Newly diagnosed cases of schizophrenia 18 to 65 years of age of either sex were randomized to olanzapine (n: 30), Risperidone (n: 30) and Quetiapine (n: 30). Each patient was followed up at 4, 6 and 10 weeks. Efficacy was assessed by using Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression - Severity of Illness scale score (CGI-S), Clinical Global Impression - Improvement of Illness scale score and Global Assessment of Functioning - Split version, Functions scale score (GAF-F). Results: - The primary analysis revealed that risperidone was slightly superior in reducing the PANSS total score at 10 weeks (28.57%) as compared to olanzapine (29.52%) and quetiapine (30.95%) while olanzapine reduced the PANSS general psychopathology sub score (28.57%) compared to risperidone (30.35%) and quetiapine (32.14%). Olanzapine and risperidone equally reduced CGI-S score 28.57% compared to quetiapine 42.85%. GAF-F score increased up to 220%for olanzapine, 200% for risperidone and 192% for quetiapine. Risperidone and olanzapine reduced the PANSS negative sub score (28.57%) each than quetiapine (42.85%). Conclusions: Overall risperidone appears to be good drug for initiating therapy in the newly diagnosed schizophrenia patients.

Keywords: Clinical Global Impression, functions scale score, Global Assessment of Functioning - Split version, Positive and Negative Syndrome Scale, schizophrenia, second generation antipsychotics

[TAG:2]NEU – 11: Comparative Evaluation of Antidepressant Activity of Tapentadol with Tramadol in Swiss Albino Mice [/TAG:2]

Shruthi KS, Narendranath S, Pradeep BS, Shashikala G, Krishnagouda Patil, Latha S

Department of Pharmacology, JJM Medical College, Davanagere, Karnataka, India

Objective: To evaluate and compare the antidepressant activity of Tapentadol with the antidepressant activity of Tramadol. Materials and Methods: The study was done after obtaining approval from the institutional animal ethical committee of JJM Medical college,Davangere and CPCSEA. A total of 30 Swiss albino mice inbred in the Central Animal House of J.J.M.M.C of either sex and of weight between 20-40g and aged 3-4 months were taken for the study. They were divided into 5 groups of 6 animals each. The anti depressant activity of tramadol and tapentadol was evaluated in mice using forced swim test model. Group i received normal saline- 10ml/kg(control group), group ii,iii,iv,v were given tramadol 20mg/kg, tramadol 40mg/kg, tapentadol 20mg/kg and tapentadol 40mg/kg respectively for 7 days. The drugs were given intraperitoneally . On day 7, the drugs were given 1 hour before conducting the experiment. The duration of immobility was noted and compared amongst the 5 groups. The observations were analysed using ANOVA(one way) and post hoc Tukey's test. Results: Both the test drugs, tramadol and tapentadol groups showed significant anti depressant activity compared to control group. Tapentadol showed greater anti depressant activity at 20mg/kg when compared to 40mg/kg.(P<0.003). Also Tapentadol at 20mg/kg showed results similar to tramadol at 20mg/kg. Conclusions: Both tramadol and tapentadol have antidepressant activity. Hence, with further clinical studies, they can be used effectively in patients having chronic pain with co-morbid depression.

Keywords: Anti-depressant activity, tapentadol, tramadol


  NEU – 12: To Compare the Safety of Saxagliptin vs Glimepiride as add on Therapy to Metformin in Patients of Type 2 Diabetes Mellitus Top


Dahiwele Akshay1, Kansal Dinesh1, Sharma Parveen1, Kapoor Dheeraj2, Sharma Aradhna1, Sood Atal1

Departments of 1Pharmacology and 2Medicine, Dr. R.P.G.M.C., Kangra at Tanda, Himachal Pradesh, India

E-mail: [email protected]

Aim: To compare the safety of saxagliptin vs glimepiride as add on therapy to metformin in patients of type 2 diabetes mellitus. Material and Methods: A prospective, randomized, comparative, interventional study was conducted in Dr. R.P.G.M.C. Kangra at Tanda. Total 60 patients were enrolled who were having uncontrolled type 2 diabetes mellitus with metformin monotherapy. Two groups were made of 30 patients each 1st group was given glimepiride (2-6mg) once a day and 2nd group was given saxagliptin (2.5-5mg) once a day separately as add on therapy to metformin 500 mg twice a day in each group. Safety was assessed by conducting LFT, RFT at 0, 1, 3, 6 month's interval. Results: Age of patient in saxagliptin group was 58.5 (mean ±SD) yrs., and in glimepiride group was 59 (mean ±SD) yrs. LFT, RFT were found to be within normal limits in both the groups. The data were compared by using unpaired t test. No statistically significant difference has been seen in both groups. Conclusions: In patients with Type 2 diabetes mellitus who were unable to reach their treatment goals with metformin alone addition of saxagliptin provided similar safety compared with glimepiride after 6 months of treatment.

Keywords: Kidney function tests, liver function tests, safety, saxagliptin

[TAG:2]NEU – 13: Comparative Evaluation of Atorvaststin and Simvastatin on Critical Fusion Frequency in Healthy Volunteers [/TAG:2]

Vijay Khajuria, Neelam Rani, Roshi, Vishal R Tandon

Department of Pharmacology, GMC, Jammu, Jammu and Kashmir, India

Introduction: Atorvastatin and Simvastatin are the most frequently prescribed amongst Statins to reduce high lipid levels. Statins are reported to alter cognitive functions. However, the results are equivocal as number of studies have shown improvement in the cognitive function (1, 2, 3) while others have documented impairment (4, 5, 6). Aim and Objective: Present study was undertaken to compare the effects of Atorvastatin and Simvastatin on critical flicker fusion frequency (CFFF) which is the most sensitive indicator of cortical arousal. So that outcome of the trial provides evidence of the alterations in cognition in unambiguous terms. Materials and Methods: A single dose, open label, cross over study was conducted in ten healthy volunteers. They were familiarized on critical flicker fusion frequency test apparatus till they attained plateau level in their values. Pre drug score was recorded before giving test drug on the trial day. Volunteers were then given oral single dose of either of drug (Atorvastatin 10 mg or Simvastatin 10 mg) and then crossed over with ten days wash out period between both treatments. In each arm volunteers were followed up to six hours for post drug score. Results: Both Atorvastatin and Simvastatin decreased the critical flicker fusion frequency significantly during entire study period (p=0.0001) from their respective pre drug values. On comparision both these drugs produced identical critical flicker fusion frequency decline (p>0.05). Conclusions: Result of current study highlights the impairment of psychomotor performance (CFFF) with both of these drugs in a similar manner. These observations could be of immense clinical importance in patients on these Statins while executing complex tasks. However the trials with long term treatment are advised to clearly define their role in Cognitive Function

Keywords: Atorvastatin, critical flicker fusion frequency, psychomotor performance, simvastatin, statins


  NEU – 14: Evaluation of Antidepressant Activity of Tapentadol in Swiss Albino Mice Using tail Suspension test and Forced Swimming Test. Top


Pradeep BE, Narendranath S, Shruthi KS, Shashikala GH, Krishnagouda Patil, Latha S

Department of Pharmacology, JJM Medical College, Davangere, Karnataka, India

Objective: To evaluate the antidepressant activity of Tapentadol using Forced Swimming test and Tail Suspension test. Materials and Methods: A total of 36 Swiss albino mice (18 for each experimental model) inbred in the Central Animal House of J.J.M.M.C of either sex and of weight between 30-40g and aged 3-4 months were taken for the study. They were divided into 3 groups of 6 animals each. The antidepressant activity of Tapentadol was evaluated in mice using Tail Suspension Test and Forced Swimming Test models. In both the experimental models, Group 1 received normal saline- 10ml/kg (Control group), groups 2, 3 were given Tapentadol 20mg/kg and Tapentadol 40mg/kg respectively for 7 days. The drugs were given intraperitoneally. On day 7, the drugs were given 40 minutes before conducting the experiment. The duration of immobility was noted and compared amongst all the 3 groups. The observations were analyzed using ANOVA (one way) and post hoc Tukey's test. Results: The duration of immobility was decreased in both the experimental models. Tapentadol groups when compared to control group shown similar and statistically significant values (P<0.000) and better results were obtained with Tapentadol 20 mg/kg groups in both the models. (Mean duration of Immobility is 34.67 seconds in FST model, 54.8 seconds in TST model compared to 102.33 seconds in FST Control and 141 seconds in TST Control groups.) Conclusions: Tapentadol hassignificant antidepressant activity. So, it can preferablybe used inpatients with chronic pain associated with depression, such as cancer pain.

Keywords: Antidepressant activity, forced swimming test, tail suspension test, tapentadol

[TAG:2]NEU – 15: Concurrent Administration of Endoplasmic Reticulum Stress Inhibitor and N-NOS Inhibitor Exhibits Synergistic Neuroprotection Against Focal Cerebral I/R Injury in Diabetic Rats [/TAG:2]

Srinivasan K, Sharma SS

Department of Pharmacology and Toxicology, National Institute of Pharmaceutical Education and Research, S.A.S Nagar, Punjab, India

Objectives: Endoplasmic reticulum (ER) stress and nitrosative stress have been reported in the pathogenesis of cerebral ischemia/reperfusion (I/R) injury. The present study was taken up to investigate whether the concurrent administration of sodium 4-phenylbytyrate (4-PBA; ER stress inhibitor) and 3-bromo-7-nitroindazole (3-BNI; nNOS inhibitor) affords enhanced neuroprotection against focal cerebral I/R injury in diabetic rats. Methods: Focal cerebral I/R injury was induced by middle cerebral artery occlusion for 2 hours followed by 22 hours of reperfusion in high fat diet (HFD)-fed and low dose streptozotocin (STZ; 35 mg/kg, i.p.)-induced diabetic rats. Effects of various combination of doses of 4-PBA (30 and 100 mg/kg, i.p.) and 3-BNI (10 mg/kg, i.p.) were investigated on functional (neurological score), histological (brain infarct and oedema volume) outcomes and molecular changes with respect to ER stress/apoptosis markers [GRP78 and CHOP/GADD153] and apoptotic DNA fragmentation in peri-infarct brain region. Results: Single dose administration of 4-PBA (30 mg/kg) or 3-BNI (10 mg/kg) did not produce significant effects. Intriguingly, the concurrent administration of 4-PBA and 3-BNI exhibited synergistic neuroprotection as evident from significant reduction in brain infarct and oedema volume in diabetic I/R rats. The drug combination significantly improved the functional recovery of neurological deficits. It also significantly reduced apoptotic DNA fragmentation associated with attenuation of GRP78 and CHOP/GADD153 immunoreactivity. Conclusion: The present study demonstrates that concurrent administration of ER stress and nitrosative stress inhibitors provides synergistic neuroprotection in experimental focal cerebral I/R injury associated with comorbid diabetes which may be attributed to reduction in ER stress and apoptotic cell death.

Keywords: 3-BNI, 4-phenylbytyrate, diabetes, focal cerebral I/R injury, neuroprotection


  NEU – 16: Melatonin Alleviates High Fat Diet and Alcohol-Induced Neurotoxicity in Rat Hippocampus via Inhibition of Calpain Activation Top


Durgesh Dwivedi1, Ashok Jangra1, Mangala Lahkar1,2

1Department of Pharmacology and Toxicology, National Institute of Pharmaceutical Education and Research, 2Deaprtment of Pharmacology, Gauhati Medical College, Guwahati, Assam, Indi

E-mail: [email protected], [email protected]

Objective: Modern lifestyle is associated with consumption of high fat diet (HFD) and alcohol (ALC). HFD stimulates intake of ALC and thereby exaggerates behavioral and neuroplastic abnormalities. Concurrent consumption of HFD and ALC may exacerbate neuronal damage due to oxidative-stress, inflammation and apoptosis. Melatonin (MEL), a well-established antioxidant and efficiently scavenges the hydroxyl and superoxide radical in pathological conditions. The present study aimed to investigate the effect of melatonin against HFD and ALC-induced neurotoxicity in rat. Methods: Wistar rats (150±20 gm) were given ALC (3% to 15% gradually increased weekly) and HFD (60% calorie from fat) for 12 weeks. MEL (10 mg/kg/day, i.p.) was administered for four weeks (9-12 week) in different groups. The behavioral and biochemical parameters were evaluated and mRNA expressions of selected genes were quantified. Results: Morris water maze test showed that MEL significantly alleviated HFD-induced learning and memory deficits. ALC, HFD and ALC+HFD consumption increases MDA and IL-1β levels and decreases glutathione level in the hippocampus. The semi-quantitative RT-PCR results showed down-regulation of Nrf-2 and HO-1 in ALC and ALC+HFD groups. Moreover, HFD, ALC and ALC+HFD groups showed down-regulation of BDNF and up-regulation of caspase-3 and NF-κB mRNA expression in the hippocampus. However, calpain expression was up-regulated in the hippocampus of ALC+HFD group. Chronic treatment of melatonin significantly ameliorated the neuroplastic deficits in ALC, HFD and ALC+HFD groups. Conclusions: Present results indicated that MEL ameliorated the HFD- and ALC-induced neurotoxicity by reducing oxidative-stress, inflammation and calpain-1 expression in hippocampus.

Keywords: Alcohol, calpain, high fat diet, melatonin, neurotoxocity

[TAG:2]NEU – 17: Reversible Inactivation of Basolateral Amygdala Prevents Stress-Induced Cognitive Deficits and Associated Structural and Molecular Alterations in the Prelimbic Cortex [/TAG:2]

Sunil Jamuna Tripathi, Suwarna Chakraborty, Srikumar BN, Raju TR, Shankaranarayana Rao BS

Department of Neurophysiology, National Institute of Mental Health and Neuro Sciences, Bengaluru, Karnataka, India

Chronic stress causes numerous negative and often long lasting neurochemical, morphological, electrophysiological and behavioural changes, which in turn result in cognitive decline and precipitate myriad of psychiatric illness including depression and anxiety. Stress exerts a contrasting pattern of changes in the basolateral amygdala (BLA) and prefrontal cortex (PFC). The BLA is known to exert positive regulation on hypothalamic-pituitary-adrenal axis and undergoes structural and molecular hypertrophy following stress. Additionally, there are emerging evidence showing the BLA, which projects to the PFC, is a target of chronic stress. However, it remains to be elucidated whether BLA hyperactivity leads to stress-induced prefrontal dysfunction. Objectives: We examined the effects of reversible blocking of the BLA during stress on cognitive functions and associated structural and molecular changes in the prelimbic cortex. Methods: Male Wistar rats were subjected to reversible blocking of BLA, prior to chronic stress followed by behavioural, stereological and biochemical assessment. Results: Following chronic stress, we observed a decrease in novelty seeking, impaired spatial learning and anxiogenic behaviour. Interestingly, reversible blocking of BLA prevented cognitive deficits and exerts an anxiolytic effect. At the structural level, stress-induced astroglial dysfunction, microgliosis and atrophy of the prelimbic cortex were precluded by reversible blocking of BLA. Further, reversible blocking of BLA also prevented the stress-induced enhanced plasma corticosterone levels and glucocorticoid receptor expression. Conclusions: These results underscore that BLA is a key target brain region to achieve efficacious remission from stress-induced detrimental effects on the PFC, with implication for developing novel strategies to treat stress-related disorders.

Keywords: Chronic stress, cognitive deficits, glucocorticoid receptors, glial plasticity, prefrontal cortex, reversible blocking of basolateral amygdala, stereology


  NEU – 18: Study of Change in Salivary Cortisol Levels in Treatment Resistant Depression Top


Kavita, Hishikar R, Sahu MK, Khodiyar PK

Objective: To observe the changes in the salivary cortisol levels in the treatment resistant depressive patients. To study the effects of antidepressant drugs given in treatment resistant patients and its association with cortisol Methods: The participants were recruited from psychiatry OPD as per DSM IV criteria, 70patients were enrolled in our study during a period of one-year study from july 2014-june 2015, out of which 52 patients came for regular follow up after 8weeks and 16weeks .and 18 patients were dropout. Study Design: Prospective cohort study Study Centre - Dr BRAM Hospital Raipur, department of psychiatry and pharmacology, Pt.JNM Medical College, Chhattisgarh Study Size: 52 cases. Study Duration: July 2014 – june 2015. Inclusion Criteria: Patients diagnosed as case of treatment resistant depression according to DSM IV criteria Age group 18 years and above. Exclusion Criteria: Patients having hormonal disorders Patients having other psychiatric illness Pregnant and lactating mothers. Patients having substance abuse disorders. The salivary cortisol samples were taken in morning hours from a patient in saliva collection device and kept in refrigeration at low temperature first baseline and after 8weeks & 16weeks and then the samples were tested bysalimetric cortisol ELISA kit. Observation: 40 patients were recovered as per more than 50 %decrease in Hamilton rating scale for depression after 8 weeks and decrease in cortisol levels.and among other 12 patients the HAMD score, there is no significant change in it and its salivary cortisol levels. Conclusions: As per results obtained we found there may be an association between the alteration in salivary cortisol and depression severity.


  NEU- 19: Umbelliferone Modulates Nitric Oxide and ION Channel Pathways in Chemically Induced Memory Deficits Top


Anudeep Kaur1, Navdeep Kaur1, Gurjit Singh1 Nirmal Singh2, Rajbir Bhatti1

1Department of Pharmaceutical Sciences, Guru Nanak Dev University, Amritsar, 2Department of Pharmaceutical Sciences and Drug Research, Punjabi University, Patiala, Punjab, India

Objective: The current study was designed to investigate the effect of umbelliferone in scopolamine induced dementia and involvement of nitric oxide and voltage gated sodium as well as calcium channels in the memory enhancing effect of umbelliferone. Materials and Methods: Swiss albino mice were employed. Briefly, animals were trained for 5 days; duration of each trial was 120 s as ceiling time. Amnesia was induced by scopolamine (0.5 mg Kg-1) injection and memory acquisition and retention was evaluated using Morris water maze, step- down paradigm, elevated plus maze and mirror chamber test. Modulation of voltage gated sodium channels and calcium channels was studied using veratrine pre- treatment and A2317 pre- treatment, respectively and modulation of nitric oxide pathways was studied using L- arginine. Results: Umbelliferone attenuates scopolamine induced increased escape latency in Morris Water Maze, decreased step-down latency in actophotometer, increased the transfer latency to the mirror chamber, decreased the number of enteries and time spent in mirror chamber, decreased the transfer latency to the closed arm in elevated plus maze. A2317, calcium ionophore and veratrine pre-treatment reversed the effect of umbelliferone. However, pretreatment with L -arginine did not alter the protective effect of umbelliferone. Conclusions: Umbelliferone reversed the scopolamine induced amnesia. The results of this study indicate that blockade of calcium influx and VGSC to be predominant mechanism in umbelliferone mediated memory enhancing effect in mice.

Keywords: Amnesia, memory, umbelliferone, VGSC


  NEU – 20: A Cross Sectional Study on Patients' Perception of Effectiveness Towards Allopathy and Alternative Therapies for Alcohol Addiction Top


Sonali Satam, Padmaja Marathe, Yashashri Shetty, Sanket Raut, Aantriksha Gupta, Shilpa Adarkar1, Shubhangi Parkar1, Nirmala N Rege

Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, 1Department of Psychiatry, De-Addiction Centre, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India

Background and Objectives: No studies from India have reported perceptions of patients regarding allopathy and alternative therapies for Alcohol deaddiction. This study was done to assessperceptions of patients regarding treatments of alcohol addiction. Methodology: One hundred patients treated for alcohol addiction for 3 or more months were enrolled in a cross-sectional study after Institutional Ethics committee permission and written informed consent. They were interviewed using a pre-validated questionnaire regarding pattern of use and perceptions regarding allopathy and alternative medicines. Data was analysed using descriptive statistics. Results: All 100 patients were males between 31-50 yrs. Ninety seven percent were addicted for over 2 years. All were offered counselling. A total of 86% received only allopathy treatment whereas 14% took combination of alternative and allopathy therapies. Lorazepam (87%), Disulfiram (1%), Acamprosate (23%), Baclofen (7%),Naltrexone(5%).Some patients took Ayurvedic (6%), Homeopathy (1%)therapies and unidentified medicines from nonregistered practitioners (7%) for less than 3 months except for one patient who continued Ayurvedic treatment for a period of 2 years. They perceived this to be quick and convenient way to get rid of addiction. Allopathy treatment was perceived to be more effective by92% of whom 41% reported it prolonged abstinence, 34% said it decreased symptoms and for 18% there was decreased craving of alcohol. Only 2 patients taking combinations reported side effects. Conclusion: Allopathy drugs were perceived to be more effective and lorazepam was the most commonly prescribed drug. Use of alternative therapies was not favoured by the patients as compared to allopathy therapy.

Keywords: Alcohol addiction, Ayurvedic treatment, craving, De-addiction Centre, Questionnaire


  NEU – 21: Design, Synthesis, In silico, In vitro and In vivo Pharmacological Evaluation of Novel Neuroprotective Agent (MMV-116) on Sh Sy-5y and Transient Focal Cerebral Ischemia in Rats Top


Vadivel K, Manohar Babu S, Muthusamy P

Department of Pharmacology, Southern Institute of Medical Sciences, Guntur, Andhra Pradesh, India

E-mail: [email protected]

Objective: To explore the in-silico, in-vitro and in-vivo evaluation of neuroprotective potential of novel neuroprotective agent (MMV-116) on SH SY-5Y and transient focal cerebral ischemia in rats. Methods: Fourteen compounds were designed and included in the present in-silico analysis to evaluate their drug likeness, major toxicity risk and binding affinity towards NMDA Receptor and COX-2 Enzyme using molecular docking software study. Based on the in-silico results, we selected MMV-116 as a best compound for synthesis, characterization and in-vitro neuroprotective evaluation by SH SY-5Y cell line and % cell viability was measured by MTT assay. Acute toxicity study is conducted as per OECD-423 guideline and in-vivo evaluation is carried out by temporary MCAo rat model with post stroke drug treatment for three days (IAEC approval number: 03/IAEC/CIPS/2015-2016, dated 29/06/2015). Neurobehavioral tests were conducted at 0, 24, 48 and 72 h after MCAo. Animals were sacrificed and brains were isolated at 72 h after reperfusion. Total infarct volumes by TTC staining, tissue calcium level and brain edema index were determined. Results: VMM-16 gained best moldock score of -136.081 and -114.43 during molecular docking with NMDA Receptor and COX-2 enzyme respectively. In silico study reveals that MMV-116 obeys Lipinski's rule of five and free from major toxicity risk. In-vitro study results have shown that MMV-116 significantly increased the percentage of human neuroblastoma cell viability is 82.80 ± 1.632. In vivo treatment of MMV-116 significantly reduced the modified bederson's score, brain tissue calcium level, infarction volume and brain edema compared with MCAO disease control during 72h after MCAo. Conclusions: In-vitro and in-vivo study demonstrated the neuroprotective effect of MMV-116 against glutamate-induced neurotoxicity on SH SY-5Y and MCAO rat model. In silico study indicates that MMV-16 is a safe and drug like compound.

Keywords: Cyclooxygenase-2 enzyme (PDB ID: 1PXX), druglikeness, NMDA Receptor (PDB ID: 3QEL), SH SY-5Y cell line, unilateral cerebral ischemia


  NEU- 22: Niflumic Acid, A Trpv1 Channel Modulator, Ameliorates Stavudine-Induced Peripheral Neuropathy Top


Rupinder Kaur Sodhi, Lovish Marwaha, Yashika Bansal, Raghunath Singh, Priyanka Saroj, Anurag Kuhad*

Pharmacology Division, University Institute of Pharmaceutical Sciences, UGC Centre of Advanced Study, Panjab University, Chandigarh, India

E-mail: [email protected]

Objective: TRP channels have been discovered as the specialized group of somatosensory neurons involved in the detection of noxious stimuli. Desensitization or amputations of TRP cation channel subfamily member i.e. TRPV1 located on dorsal root and trigeminal ganglia exhibits analgesic effect and makes it potential therapeutic target for treatment of neuropathic pain. Materials and Methods: Intravenous injection of stavudine (50mg/kg, 4 days apart) induced neuropathic pain in rats. Rats developed thermal and mechanical hypersensitivity which plateaued on 28 th day after initial injection as assessed by Randall-Selitto, Von-Frey, Cold-plate and Hot-plate. Impairment in motor nerve conduction velocity was also calculated on 30-31 st day. In addition biochemical parameters were assessed to discover changes in oxidative stress markers, TRPV1 levels, IL-1β and TNF-α level. Results: Acute treatment with niflumic acid (10, 15 and 20 mg/kg) and pregabalin (30 mg/kg) significantly restored changes in biochemical, electrophysiological and molecular levels by targeting TRPV1 channels and α 2 δ subunit (A2D)-containing voltage-gated calcium channels respectively which account for its therapeutic effect on neuropathic pain. Conclusions: NA restored the core and associated symptoms of peripheral neuropathy by suppressing oxido-nitrosative stress, TNF-α, IL-1β and TRPV1 level in stavudine-induced neuropathic pain in rats. Therefore, NA can be developed as a potential pharmacotherapeutic adjunct for antiretroviral drug-induced neuropathy.

Keywords: Motor nerve conduction velocity, neuropathic pain, niflumic acid, pregabalin, stavudine, TRPV1


  NEU – 23: TRPV1 Channel Modulator, 2-Aminoethoxydiphenyl Borate Protects against 3-Nitropropionic Acid-Induced Huntington's Disease in Rats Top


Priyanka Saroj, Yashika Bansal, Raghunath Singh, Sangeeta P Sah, Anurag Kuhad

University Institute of Pharmaceutical Sciences, Panjab University, Chandigarh, India

E-mail: [email protected], [email protected]

Background: 2-aminoethoxydiphenyl borate (2-APB) is an inhibitor of inositol 3- phosphate (IP3) and modulator of transient receptor potential (TRPV1) channel, both are responsible for increasing intracellular Ca++ concentration and subsequent excitotoxicity which leads to apoptosis and neurodegeneration and also found to be involve in progression of Huntington's disease (HD). Objective: With this background present study has been designed to explore the possible role of 2-APB against 3-NP induced behavioral, biochemical and cellular alterations. Methods: Intraperitoneal (i.p.) administration of 3-nitropropionic acid (10 mg/kg for 14 days) and 2-APB (5, 10 and 15 mg/kg, i.p.) once daily treatment for a period of 14 days were used. 2-APB was administered 1 h prior to 3-NP administration. Loss in body weight, motor in-coordination (locomotor activity and rota rod performance) and poor memory retention in Morris water maze tasks were evaluated in 7th and 14th day. On 14th day of the study lipid peroxidation, nitrite concentration and depleted superoxide dismutase, catalase levels and alterations in mitochondrial complex enzymes (I, II, IV) in the different regions (striatum, cortex and hippocampus) of rat brain were examined. Results: 2-APB once daily treatment for a period of 14 days significantly improved motor performance and escape latency time, time spent in target quadrant in Morris water maze. Further, 2-APB treatment significantly attenuated oxidative damage and improved mitochondrial complexes enzyme activities in different regions of rat brain. TRPV1 levels were also found to be reduced in rat brain (striatum). Conclusions: The results suggest that 2-APB could be an alternative therapy in management of HD. Further molecular estimations done like intracellular Ca++ concentration and apoptotic markers are needed to explored extensively.

Keywords: 2-aminoethoxydiphenyl borate, 3-Nitropropionic acid, Huntington's disease, mitochondria


  NEU – 24: NDGA Reverses Depression Like Behavioural and Biochemical Alterations in OBX Mice Through Kynurenine Pathway Top


Yashika Bansal, Raghunath Singh, Priyanka Saroj, Anurag Kuhad*

Pharmacology Research Lab, University Institute of Pharmaceutical Sciences, UGC-Centre of Advanced Study, Panjab University, Chandigarh, India

E-mail: [email protected]

Objective: Mounting evidences showed that increased proinflammatory cytokines contribute to the development of depression. Increased inflammatory cytokines enhances the activity of indoleamine 2,3 dioxygenase which is the rate limiting step in kynurenine pathway and hence leads to increase in neurotoxic metabolites of and decreases 5-HT levels. The aim of study was to evaluate the pharmacotherapeutic efficacy of NDGA in experimental paradigm of depression i.e. olfactory bulbectomy (OB) specifically targeting kynurenine pathway. Materials and Methods: Depression like behaviours was induced in OB mice as evaluated by assessment of various behavioural (olfactory deficit test, forced swim test, splash test, open field test, sucrose preference test), biochemical (MAO-A, corticosterone) and inflammatory cytokines (TNF- α, IL-1β, IL-6, IFN-γ) levels. Kynurenine pathway metabolites were determined in brain using HPLC method. After 14 days post-surgery, olfactory bulbectomized (OBX) mice were administered nordihydroguaiaretic acid (5mg/kg, 10mg/kg and 25mg/kg) daily i.p. Results: We have developed a new HPLC method for simultaneous estimation of monoamines and kynurenine pathway metabolites in plasma and brain samples of mice. Chronic treatment with nordihydroguaiaretic acid significantly restored all behavioural, biochemical and neurochemical alterations in OBX mice and increase in quinolinic acid and decrease in kynurenic acid point out the neurodegeneration hypothesis of depression. Conclusions: Nordihydroguaiaretic acid showed potent neuropharmacotherapeutic effect in OBX mice by virtue of its strong anti-inflammatory, anti-stress and by restoring quinolinic acid levels.

Keywords: Depression, kynurenine, NDGA, olfactory bulbectomy, pro-inflammatory cytokines


  NEU – 25: Evaluation of LXR agonist in Aβ induced Alzheimer's disease along with hypercholesterolemia Top


Annie R Mecwan, Rudra S Vyas, Kirti V Patel, Shri SP Rathod

Faculty of Pharmacy, The Maharaja Sayajirao University of Baroda, Vadodara, Gujarat, India

Objective: To evaluate LXR agonist in Aβ induced Alzheimer's disease along with hypercholesterolemia. Methods: increase in ELT, serum total cholesterol, LDL, triglycerides, brain AchE activity, glutamate levels and MDA levels and a significant decrease in SAP, brain weight/body weight ratio, serum HDL, tissue GSH levels a Male Sprague Dawley rats of 4-5 weeks were randomly allocated to following 11 groups based on their initial cholesterol levels: Group 1-Normal control [NC] (Saline,p.o.), Group 2-Sham operated [SO] (0.9% saline 5μl i.c.v), Group 3- Model control 1 [MC1] (High fat diet), Group 4- Model control 2 [MC2] (Aβ (1-42)), Group 5-Model control 3 [MC3] (HFD+Aβ (1-42)), Group 6- Treatment group [T1] (MC2 + Lansoprazole (10mg/kg i.m.)), Group 7- Test group 2 [T2] (MC3 + Lansoprazole (10mg/kg p.o.)), Group 8-Standard treatment 1 [S1] (MC3 + Donepezil (5mg/kg p.o)), Group 9-Standard treatment 2 [S2] (MC3 + Simvastatin (10mg/kg p.o.)), Group 10-Standard treatment 3 [S3] (MC3 +Donepezil (5mg/kg p.o.) + Simvastatin (10mg/kg p.o.)), Group 11-Treatment group 3[T3] (MC3 + Simvastatin (10mg/kg p.o.) + Donepezil (5mg/kg p.o.) + Lansoprazole (10mg/kg i.m)). After 21 days of treatment in Aβ treated groups, % spontaneous alteration performance in radial Y-maze, escape latency time in morris water maze, brain weight/body weight ratio, serum total cholesterol, triglycerides, HDL, LDL, glucose, brain AchE activity, brain glycine levels, glutamate levels, tissue MDA levels, GSH levels, SOD activity and histopathology were estimated. Results: HFD fed animals showed significant nd SOD activity. Lansoprazole treatment in Aβ(1-42) treated animals showed no significant change in SAP, significant increase in brain weight/body weight ratio, serum triglyceride, brain AchE activity glutamate levels and layers of pyramidal cells while a significant decrease in ELT, glycine levels and apoptotic cells. Treatment with Lansoprazole in Aβ(1-42) + HFD treated animals showed significant increase in SAP while in decrease in ELT, AchE activity, brain glutamate levels and apoptotic cells. No significant change in other parameters was observed. Treatment with a combination of Lansoprazole + Donepezil + Simvastatin in Aβ + HFD treated animals showed significant increase in brain weight/body weight ratio, HDL, and GSH levels and decrease in ELT, brain AchE activity and glutamate levels. Results were supported by histopathology. Conclusion: The present study confirms hypercholesterolemia as one of the risk factor in Alzheimer's disease. Lansoprazole treatment produce some significant change in AchE activity, change in glycine and glutamate levels and also suggesting antioxidant property. LXR hypothesis might have a role in Alzheimer's disease.

Keywords: Alzheimer's disease, HFD, hypercholesterolemia, lansoprazole, LXR agonist


  NEU – 26: Antidepressant Properties of Atorvastatin and Rosuvastatin in Wistar Albino Rats Top


Madhavrao C, Mythili Bai K, Rema Menon N1, Sarath Babu K1, Prathab Asir A1

Department of Pharmacology, VBMC, Kurnool, Andhra Pradesh, 1Department of Pharmacology, SMIMS, Kulasekharam, Tamil Nadu, India

Aims and Objectives: To evaluate the antidepressant properties of atorvastatin and rosuvastatin in Wistar albino rats. Materials and Methods: The adult, healthy Wistar albino rats of either sex weighing between 180 -250 g were procured from the central animal house and they were allowed to acclimatize to the departmental research laboratory for 7 days. Experimental animals were provided standard food pellet and all experiments were carried at the same time during day hours, strictly adhering to the CPCSEA guidelines. The study protocol was approved by the IRB. In this study, experimental animals were randomly assigned to 8 groups, with 6 animals in each group [n=48]. The antidepressant property was tested using Tail Suspension Test [TST] and Forced Swim Test [FST]. Group-I: Control for TST, Group-II: Standard for TST [Imipramine 20 mg/Kg BW i.p], Group-III: Atorvastatin for TST [7 mg/kg BW i.p], Group-IV: Rosuvastatin for TST [4 mg/kg BW i.p], Group-V: Control for FST, Group-VI: Standard for FST [Imipramine 20 mg/Kg BW i.p], Group-VII: Atorvastatin for FST [7 mg/kg BW i.p] and Group-VIII: Rosuvastatin for FST [4 mg/kg BW i.p]. The data was subjected to one-way ANOVA with Bonferroni Post hoc for any statistical significance among different groups. P value of > 0.05 was considered as statistically significant. Results: The imipramine [Standard drug] in Group II and experimental test drugs [atorvastatin and rosuvastatin] in Group III and IV respectively, produced statistical significant decline in immobility time in total 5 minutes' test when compared to the control group [Group-I] in TST model. Again the imipramine [Standard drug] in Group VI and experimental test drugs [atorvastatin and rosuvastatin] in Group VII and VIII respectively, also produced statistical significant decline in immobility time in last 4 minutes of total 6 minutes' test when compared to the control group [Group-V] in FST model. Conclusions: Atorvastatin and rosuvastatin exhibited significant antidepressant properties in TST and FST tests in Wistar albino rats.

Keywords: Atorvastatin, depression, forced swim test, rosuvastatin, tail suspension test


  NEU – 27: Preclinical Evaluation of Antiepileptic Activity of Lercanidipine and Flunarizine in Wistar Albino Rats Top


Madhavrao C1, Mythili Bai K2, Rema Menon N3, Sarath Babu K4, Prathab Asir A5

Department of Pharmacology, VBMC, Kurnool, Andhra Pradesh, 1Department of Pharmacology, SMIMS, Kulasekharam, Tamil Nadu, India

Aims and Objectives: To evaluate the antiepileptic activity of lercanidipine and flunarizine in PTZ and MES induced seizure model tests in Wistar albino rats. Materials and Methods: After obtaining the approval of study proposal by the Institutional Animal Ethics Committee [IAEC], the study was conducted in accordance with the Committee for the Purpose of Control and Supervision of Experiments on Animals [CPCSEA] guidelines. In this study, adult healthy Wistar albino rats were randomly assigned to 8 groups, with 6 animals in each group [n=48]. Group-I: Control for PTZ, Group-II: Standard for PTZ [Sodium valproate 150 mg/Kg BW i.p], Group-III: Lercanidipine for PTZ [2 mg/kg BW i.p], Group-IV: Flunarizine for PTZ [20 mg/kg BW i.p], Group-V: Control for MES, Group-VI: Standard for MES [Diphenylhydantoin 25 mg/Kg BW i.p], Group-VII: Lercanidipine for MES [2 mg/kg BW i.p] and Group-VIII: Flunarizine for MES [20 mg/kg BW i.p]. The statistical analysis was carried using one way ANOVA with Bonferroni Post hoc for differences among groups. P value of less than 0.05 was considered as statistically significant. Results: The sodium valproate [Standard drug] in Group II and experimental test drugs [lercanidipine and flunarizine] in Group III and IV respectively, produced statistical significant decline in onset, duration and number of seizures when compared to the control group [Group-I] in PTZ model. The diphenylhydantoin [Standard drug] in Group VI and experimental test drugs [lercanidipine and flunarizine] in Group VII and VIII respectively, also produced statistical significant decline in THLE and scores of seizures when compared to the control group [Group-V] in MES model. Conclusions: Lercanidipine and flunarizine possess significant antiepileptic activity in PTZ and MES induced seizure model tests in Wistar albino rats.

Keywords: Epilepsy, flunarizine, lercanidipine, MES, pentylenetetrazole, PTZ, seizures.


  NEU – 28: Non-Invasive Remote Limb Perconditioning Mediated Neuroprotection against Cerebral Ischemic Stroke Top


Sruthi Ramagiri, Rajeev Taliyan

Birla Institute of Technology and Sciences, Pilani, Rajasthan, India

Introduction: Ischemic reperfusion (I/R) injury associated with cerebral stroke is an emergency clinical situation associated significant mortality and morbidity. The neuroprotective effect of remote limb ischemic post conditioning against cerebral I/R injury has been explored in our previous studies. However, the attenuation of cerebral damage following clinically relevant strategy, remote perconditioning and underlying molecular mechanisms are still largely unexplored. Materials and Methods: Adult male Wistar were randomized into 1. Sham group (no mechanical intervention), 2. I/R group (bilateral common carotid artery occlusion for 60 min), 3. RPERC (4 cycles of Femoral artery occlusion (5min) and reperfusion (5 min) during ischemic phase. Neurological scores were done 1 and 7 day after reperfusion. Beam crossing test and rotarod were performed to assess the motor coordination. Biochemical parameters including malondialdehyde (MDA), glutathione, catalase and nitrite were measured. Further, neuroinflammation was estimated by TNF-α while hippocampal structural alteration was analysed by hematoxylin and eosin (H and E) staining. Furthermore, TUNEL assay was performed to score the apoptotic neurons in hippocampus. Results: I/R injured rats showed severe neurological deficits and motor incoordination, along with aggravated oxidative and neuroinflammatory response. Induction of I/R injury also resulted in hippocampal damage as indicated by pyknotic neurons in H and E staining and apoptotic neurons in TUNEL assay. However, RPERC intervention ameliorated the neurobehavioral and biochemical parameters along with hippocampal neurogenesis. Conclusions: Based on the results of present study, it could be suggested that neuroprotective role of RPERC against cerebral I/R injury is mediated by modulation of BDNF and TNF- α levels and attenuation of hippocampal damage.

Keywords: Apoptosis, cerebral stroke, femoral artery, remote conditioning


  NEU – 29: Pharmacological Evaluation of Sida cordifolia against Rotenone Induced Rat Model of Parkinson's Disease Top


Navneet Khurana, Neha Sharma, Shailendra Patil1, Asmita Gajbhiye1

Department of Pharmacology, School of Pharmaceutical Sciences, Lovely Professional University, Phagwara, Punjab, 1Department of Pharmaceutical Sciences, Dr. Hari Singh Gour University, Sagar, Madhya Pradesh, India

E-mail: [email protected]

Objectives: The present study was designed to investigate the ameliorative effect of aqueous extract of Sida cordifolia (AESC), and its different fractions; hexane (HFSC), chloroform (CFSC) and aqueous (AFSC), against rotenone induced oxidative damage and dopamine depletion along with associated behavioral alterations in a rat model of Parkinson's disease (PD). Methods: Sprague Dawley male rats were divided into various groups for administration of varying doses of different treatments daily, for a period of 35 days. It includes AESC, HFSC, CFSC and AFSC per se treatment, at a dose of 100 mg/kg, along with rotenone (2 mg/kg; s.c.) co-administered treatments of AESC, HFSC, CFSC and AFSC, at varying doses (50, 100, 150 mg/kg; i.p.). The test treatments were compared with vehicle (normal control), rotenone (negative control) and L-deprenyl (positive control; 10 mg/kg; i.p.) treated groups. Results: The co-treatment of varying doses of AESC and AFSC attenuated the rotenone induced PD-like behavior alterations, as evident by the significant (P<0.05) decrease in behaviour scores, catalepsy and posture instability along with increase in locomotor activity, muscle coordination and rearing behaviour as compared to rotenone treated group. Rotenone induced decrease in dopamine content and increase in lipid peroxidation was also reversed by co-treatment of AESC (100 mg/kg) and AFSC (100 mg/kg). Conclusion: Antioxidant activity of AFSC was responsible for its ameliorative effect against rotenone induced oxidative damage and PD-like behavioral symptoms. These findings suggested the scope of AFSC in developing therapeutic strategies for PD.

Keywords: catalepsy, dopamine, Parkinson's disease, rotenone, Sida cordifolia


  NEU – 30: Taurine Ameliorates Intracerebroventricular-Streptozotocin Induced Sporadic Model of Alzheimer's Disease and Neuroinflammation in Rats Top


Reeta KH, Devendra Singh, YK Gupta

Department of Pharmacology, All India Institute of Medical Sciences, New Delhi, India

E-mail: [email protected]

Background: Taurine, an endogenous amino acid found abundantly in humans, has demonstrated neuroprotective properties against dementia. Pro inflammatory cytokines and lipoxygenase (LOX) play important role in progress of Alzheimer's disease (AD). This study evaluated the effect of taurine on inflammatory markers in intracerebroventricular- streptozotocin (ICV-STZ) induced sporadic model of AD in rats. Materials and Methods: Male Wistar rats (270±20g), procured from Central Animal Facility, AIIMS, New Delhi were administered ICV-STZ (3 mg/kg on day 0) stereotaxically. Taurine (60 mg/kg and 120 mg/kg, oral) was administered for 28 days. Morris water maze test was carried out on 0, 14 and 28 days. On 29th day, rats were sacrificed, cortex and hippocampus were separated and homogenised. The levels of LOX, TNF-α and IL-1β were estimated using commercially available ELISA kits. Results: STZ produced memory impairment as evidenced by increased escape latency (p<0.001), decreased time spent in target zone (p<0.001) in Morris water maze test. Taurine (120 mg/kg) attenuated the increased escape latency and improved the time spent in target quadrant on 14th (p<0.05) and 28th (p<0.01) days. TNF-α levels were significantly increased in cortex (p<0.01) and hippocampus (p<0.001) in STZ group. Taurine significantly reduced the TNF-α both in cortex as well as hippocampus as compared to STZ group. Moreover, taurine ameliorated the STZ induced increased levels of IL-1β in cortex and hippocampus. However, there was no significant change in the levels of LOX in any group. Conclusions: The results suggest that taurine improves STZ-induced cognitive impairment by ameliorating neuro inflammation in cortex and hippocampus.


  NEU- 31: Study of Safety and Efficacy of the Combination of Amitriptyline and Mecobalamin in Neuropathic Pain: Data of AMNEST Trial Top


Mayuresh Kiran, Lalit J Pawaskar

Department of Medical Services, Centaur Pharmaceuticals Pvt Ltd, Mumbai, Maharashtra, India

Abstract: Objective: To evaluate the safety and efficacy of the combination of amitriptyline and mecobalamin in Neuropathic Pain. Methods: AMNEST Study was conducted at 72 centres on 786 patients across India. The patients above 18 years with neuropathic pain who satisfied the inclusion and exclusion criteria were enrolled in the study. A combination of amitriptyline and mecobalamin was given once daily at night before sleep. Patients were evaluated for the efficacy by visual analogue scale (VAS). Safety was evaluated through the noted adverse events occurring during the clinical trial. Patients VAS score were noted at visit 1 (baseline), visit 2 at day 30, visit 3 at day 45 and also asked for any adverse events. Change in mean VAS score, percent decrease in pain intensity between visits and percentage of patients achieving ≥50% reduction in pain from the baseline (NNT) was assessed. Results: Mean VAS score at baseline was 7.39 decreased to 5.6 at day 30 and 3.99 at day 45. The percent decrease in mean VAS score was 24.22% and 46% at day 30 and 45 respectively. 82.44% patients at the end of the study had ≥50% reduction in neuropathic pain. Calculated NNT was 1.21 at the end of the study. Adverse effects were observed in 6% of patients – Dry Mouth, Sedation and Constipation. Conclusion: The combination of amitriptyline and mecobalamin is safe and efficacious in the treatment of neuropathic pain.

Keywords: Amitriptyline, mecobalamin, neuropathic pain


  NEU – 32: Interaction Profile of Panchagavya ghrita with Sodium Valproate and Phenobarbital in Pentylenetetrazole Induced Seizures in Rats: Pharmacodynamic and Pharmacokinetic Study Top


Rupa Joshi, Reeta KH, Sharma SK1, Tripathi M2, Gupta YK

Departments of Pharmacologyand 2Department of Neurology, All India Institute of Medical Sciences, 1Department of AYUSH, Ministry of Health and Family Welfare, Government of India, New Delhi, India

Objectives: Panchagavya Ghrita (PG) is an Ayurvedic medicine mentioned in Charak Samhita for treatment of epilepsy. The present study evaluated the pharmacodynamic and pharmacokinetic interactions of PG with sodium valproate (VPA) and phenobarbital (PB) in pentylenetetrazole (PTZ) induced seizures in rats. Methods: Male Wistar rats were administered PG (2000 mg/kg) orally for 7 days and seizures were induced by PTZ (60 mg/kg, i.p.), 120 min after the last dose of PG on day 7. Antiepileptic drugs (AEDs) were administered in therapeutic [VPA (300 mg/kg); PB (40 mg/kg)] and subtherapeutic doses [VPA (75, 100 and 150 mg/kg); PB (5, 10 and 20 mg/kg)] 30 and 60 min, respectively before induction of seizures on day 7. Behavioral parameters were assessed using elevated plus maze and passive avoidance test. Rat brain oxidative stress parameters (malondialdehyde and reduced glutathione) and serum levels of VPA and PB were estimated. Results: Co-administration of PG with VPA and PB significantly increased percentage protection against PTZ induced GTCS as compared to VPA and PB alone treated groups. Seizures induced memory impairment and oxidative stress was significantly prevented by PG when co-administered with subtherapeutic doses of these AEDs as compared to subtherapeutic doses alone treated groups. Co-administration of PG with VPA and PB did not alter their serum levels. Conclusion: Co-administration of PG with these AEDs increased their antiepileptic effect without altering their serum levels. Thus, it may be used as an adjunct to these AEDs in epilepsy to reduce their side effects and improve their efficacy.

Keywords: Cognitive impairment, oxidative stress, Panchagavya Ghrita, pentylenetetrazole, seizures


  NEU – 33: Potentiation of Pentylenetetrazole Induced Neuronal Damage by Dimethyl Sulfoxide in Chemical Kindling Model in Rat Top


Puja Kumari, Neha, Lekha Saha

Department of Pharmacology, Post Graduate Institute of Medical Education and Research, Chandigarh, India

Objectives: Many hydrophobic drugs are dissolved in dimethyl sulfoxide (DMSO) and are used experimentally in pentylenetetrazole (PTZ) model of epilepsy. The present study is aimed to evaluate the effect of low concentration of DMSO (0.1%) on PTZ induced neuronal damage in chemical kindling model in rat. Materials and Methods: Young male wistar rats were taken and divided into 4 groups: Group I- normal saline (1 ml/kg, i.p); Group II- 0.1% DMSO (1 ml/kg,i.p); Group III- PTZ (35mg/kg, i.p) and Group IV- 0.1% DMSO+PTZ (35mg/kg). DMSO was administered 30 mins before PTZ administration. All drugs were given every alternate day until the animal develops kindling or upto 10 weeks and were observed for seizure score, latency to develop kindling, percentage of animals kindled and histopathological score. Results: Seizure score was significantly increased in the PTZ+DMSO treated group (4.12 ± 0.35) as compared to PTZ treated group (3.37 ± 0.88). Also the histopathological score in the combination group (3.75 ± 0.46) was significantly higher as compared to PTZ alone treated group (2.88 ± 0.83). Furthermore, the latency of kindling was decreased in the DMSO+PTZ (3rd week) group as compared to PTZ (6th week) group. Conclusions: It can be concluded that the use of 0.1% DMSO in PTZ induced rat model of epileptogenesis need further optimization and should be used cautiously as it may lead to misinterpretation of the results.

Keywords: Dimethyl sulfoxide, neuronal damage, pentylenetetrazole kindling, potentiation


  NEU – 34: Ameliorative Potential of Pioglitazone and Ceftriaxone Alone and in Combination in Rat Model of Neuropathic Pain: Targeting PPARγ and GLT-1 Pathways Top


Harshpreet Kaur, Raghavender Pottabathini, Anil Kumar

Pharmacology Division, University Institute of Pharmaceutical Sciences, UGC Centre of Advanced Study, Panjab University, Chandigarh, India

E-mail address: [email protected]

Objective: The relation between glutamate homeostasis and PPAR gamma has got tremendous importance in nerve trauma and pain. Present study has been designed to elucidate the interaction between the GLT-1 activator (ceftriaxone) and PPAR gamma agonist (pioglitazone) in the spinal nerve ligation induced neuropathic pain. Materials and Methods: Male SD rats were subjected to spinal nerve ligation to induce neuropathic pain. Pioglitazone, ceftriaxone and their combination treatments were given for 28 days. Various behavioral, biochemical, neuroinflammatory and apoptotic mediators were assessed subsequently. Results: In the present study, ligation of L5 and L6 spinal nerves resulted in marked hyperalgesia and allodynia to different mechanical and thermal stimuli. In addition, there is marked increase in oxidative– nitrosative stress parameters, inflammatory and apoptotic markers in spinal cord of spinal nerve ligated rats. Treatment with pioglitazone and ceftriaxone significantly prevented these behavioral, biochemical, mitochondrial and cellular alterations in rats. Further, combination of pioglitazone (10 mg/kg, ip) with ceftriaxone (100 mg/kg, ip) significantly potentiated the protective effects as compared to their effects per se. Conclusion: Based on these results we propose that possible interplay between the neuroprotective effects of pioglitazone and ceftriaxone exists in suppressing the behavioral, biochemical, mitochondrial, neuroinflammatory and apoptotic cascades in spinal nerve ligation induced neuropathic pain in rats.

Keywords: GLT-1, neuropathic pain, PPARgamma, spinal nerve ligation


  NEU – 35: Naringin Ameliorates Neuroinflammation, Oxidative Stress Mediated Memory Loss in Experimental Model of Aβ(1–42) Induced Alzheimer's Disease Top


Ravinder Naik Dharavath, Anand Kamal Sachdeva, Kanwaljit Chopra

Pharmacology Research Laboratory, University Institute of Pharmaceutical Sciences, Panjab University, Chandigarh

E-mail: [email protected]

Objectives: Neuroinflammation is characterized by glial activation and release of proinflammatory mediators and successive oxidative stress are considered to play a critical role in the pathogenesis of Alzheimer's disease (AD). β – Amyloid 1-42 (Aβ1–42) induced learning and memory impairment in rats is believed to be associated with neuronal inflammation. Therefore, this study was designed to elucidate neuroprotective mechanism of Naringin in β-Amyloid1–42 induced AD. Methods: ICV Aβ1–42 was injected bilaterally followed by treatment with Naringin or rivastigmine for 14 days. Morris water maze and elevated plus maze tests were used to assess the memory functions. Rats were sacrificed and cerebral cortex and hippocampus were harvested to evaluate various biochemical parameters and mitochondrial complex. The levels of tumor necrosis factor-α (TNF-α), interleukin 1β (IL-1β), tumor growth factor β (TGF-β), nuclear factor-κB (NF-κB) and caspase-3 were assessed by enzyme-linked immunosorbent assay analysis. Results: Naringin significantly attenuated Aβ-induced learning and memory deficits in a dose-dependent manner. Aβ1–42-induced mitochondrial dysfunction along with surge of proinflammatory cytokines TNF-α, TGF-β and IL-1β as well as NF-κB and caspase-3 activity in rat brain was significantly mitigated with Naringin treatment. Conclusion: The amelioration of Aβ1–42-induced spatial learning and memory impairment by Naringin could be linked, at least in part to the inhibition of NF-κB activity and the downregulation of expression of neuroinflammatory cytokines, suggesting that Naringin can be therapeutically explored for AD.

[TAG:2]NEU – 36: Fluoxetine Reverses Depression-Induced Cognitive Deficits Through Structural Plasticity in the Hippocampus and Amygdala [/TAG:2]

Suwarna Chakraborty, Sunil Jamuna Tripathi, Suraksha SH, Anusha SJ, Srikumar BN, Raju TR, Shankaranarayana Rao BS

Department of Neurophysiology, National Institute of Mental Health and Neuro Sciences, Bengaluru, Karnataka, India

Background: Depression is a devastating disease associated with suicidal tendencies, anxiety as well as an increased risk of dementia. Several studies have provided evidence for hippocampal-dependent cognitive deficits and amygdalar-dependent enhanced anxiety in depressed patients. These changes in hippocampal and amygdalar function are thought to be the targets of antidepressants. The selective serotonin reuptake inhibitors (SSRIs) are the first line therapy for depression, but the mechanism of SSRI-mediated progressive structural plasticity remains to be elucidated. Additionally, SSRI has enormous lag time in onset of action, suggesting long-lasting structural and neurochemical changes mediates its effect. Accordingly, reversal of regressive plasticity during depression might be a target for chronic SSRI treatment. Objectives: We investigated the effect of chronic fluoxetine treatment on volumes of hippocampal subfields and different amygdalar nuclei and accompanying cognitive deficits in depressive animals. Methods: Male Wistar neonates were subjected to clomipramine administration followed by fluoxetine treatment in adulthood and assessment of behavioural and structural alterations. Results: Clomipramine administered animals exhibited depressive, anhedonic, anxiety-like symptoms with impaired learning. These behavioural deficits were correlated with atrophy of CA1, hilus and dentate gyrus, sparing CA2, CA3 subfields. In contrast, we observed a hypertrophy of the basolateral amygdala with no changes in central and lateral amygdalar volumes. Interestingly, chronic treatment with fluoxetine reversed the depression-induced impairment in learning and associated volumetric atrophy in the CA1, hilus, dentate gyrus, and hypertrophy in the basolateral amygdala. Conclusions: This study suggests that differential structural plasticity in the hippocampus and amygdala has a role in fluoxetine-mediated antidepressant effects.

Keywords: Amygdalar nuclei, cognitive deficits, depression, hippocampal subfields, stereology, structural plasticity


  TOX (TOXICOLOGY) Top



  TOX – 1: Comparative Evaluation of Efficacy of Fexofenadine in Autologous Serum Skin Test Negative and Autologous Serum Skin Test Positive, Chronic Urticaria Patients Top


Purohit G, Srivastav B, Agarwal S1, Gaur S

Departments of Pharmacology and 1Dermatology, Susheela tiwari Hospital Government Medical College, Haldwani, Uttarakhand, India

Introduction: Chronic Urticaria is a common dermatological disorder, characterized by spontaneous wheal, recurrent pruritic and eythematous lesions that persist for more than six weeks. It has major impact on quality of life. Autologous serum skin test (ASST) has been internationally adopted as clinical test to demonstrate the circulating auto antibodies. First and second generation antihistamines are the main stay of treatment. Fexofenadine, a metabolite of terfinadine is a second generation antihistamine mainly used in allergic rhinitis and urticaria. Aim: To compare and evaluate the efficacy of fexofenadine in Autologous serum skin test negative and positive chronic urticaria patients, relationship of ASST Negative and positive patients with angioedema, correlation with thyroid, atopy or asthma, effect of therapy on urticaria activity score and life quality index. Materials and Methods: Unicentre, Open labeled, prospective, comparative clinical study which was undertaken for a study period of 1 year i.e. from September (2014 -2015) in the department of Pharmacology and outpatient department of Dermatology. The study population involved naïve chronic urticaria patient, who were subjected to ASST and grouped into ASST Negative and Positive. Results: In 66 patients of chronic urticaria, ASST was negative in 47% and positive in 53%.Female to male ratio was 2:1, mainly the adult group (31-45 years) was affected, angioedema was present in 54.3% and 35.5% of ASST positive and negative respectively. Family history and thyroid correlation was present in 31.4% and22.9% of ASST Positive patients respectively. Fexofenadine proved to be effective in both the groups, the urticaria activity score found to be statistically significant (p=0.029) and significant(p=0.001) improvement in absolute eosinophil count(AEC) were seen in both the groups with marked improvement in Life quality index. Conclusion: chronic urticaria cannot be cured but can be controlled effectively with second generation antihistaminics. ASST can be considered a screening test which can minimize the burden of other lab investigations. ASST negative and ASST positive showed no statistically significant difference for epidemiological details, although our study revealed there is need of additional antihistaminics more in ASST positive group. Improvement in UAS proves that chronic urticaria can be significantly controlled by fexofenadine, few cases might need additional therapy. UAS is proved to be an important tool to assess the severity of disease and to decide the line of management.

Keywords: Autologous serum skin test, chronic urticarial, fexofenadine, urticaria activity scores


  TOX – 2: Synergistic Effect of Ferulic Acid and Ascorbic Acid in Aniline Induced Spleen Toxicity in Rats Top


Aman B Upaganlawar

Department of Pharmacology, SNJBs SSDJ College of Pharmacy, Neminagar, Chandwad. India

E-mail: [email protected]

Objective: The present study was design to evaluate the protective effects of ferulic acid and ascorbic acid alone and in combination in aniline hydrochloride induced spleen toxicity in rats. Methods: Wistar rats of either sex (200-250 gm) were used in the study. Spleen toxicity was induced in rats by aniline hydrochloride (100ppm) in drinking water for 30 days. Treatment group received ferulic acid (40mg/kg/day, p.o) and ascorbic acid (40mg/kg/day, p.o) alone and in combination for 30 days. At the end of treatment period various parameters from serum and tissue were evaluated. Results: Aniline hydrochloride treated rats showed a significant alteration in body weight, spleen weight, feed consumption, water intake, haematological parameters (Haemoglobin, RBC, WBC and total Iron content), biochemical parameters (Protein, lipid peroxidation, reduced glutathione and nitric oxide), and membrane bound phosphatase (ATPase). Treatment with combination of ferulic acid and ascorbic acid (40mg/kg) respectively showed a significant recovery in aniline induce spleen toxicity. Histopathology of spleen supports the biochemical results. Conclusion: Combination of ferulic acid and ascorbic acid showed better effects than alone antioxidants in aniline hydrochloride induced spleen toxicity.

Keywords: Aniline hydrochloride, antioxidant, ascorbic acid, ferulic acid, spleen toxicity


  TOX – 3: Poisoning Calls Reported to National Poisons Information Centre, AIIMS, New Delhi: A Five Year Retrospective Study Top


Sharda Shah Peshin, Amita Srivastava, Yogendra Kumar Gupta

Department of Pharmacology, National Poisons Information Centre, All India Institute of Medical Sciences, New Delhi, India

Objectives: To determine the incidence and pattern of telephonic poisoning calls,made to National Poisons Information Centre(NPIC), by treating physicians over five years (Apr.2010-Mar.2015). Methods: The call details were entered into a preset proforma and then into a retrievable database.The substances commonly involved in poisoning were classified into household products, agricultural pesticides, industrial chemicals, drugs, bites and stings, plants, unknown and miscellaneous groups. The programme provided a correlation of incidence with age, sex, route, mode and type of poisoning. Results: A total of 10,145 calls were received during five years, with 95.66% calls on management of poisoning and 4.33% seeking information about various products and functioning of the Centre.Age ranged from<1yr.-70yrs.Males outnumbered females (M=61.76%, F=38.23%).Mode of poisoning was mainly unintentional (60.47%) followed by intentional mode (34.41%). The commonest route of exposure was oral (95.21%).The household products were most commonly implicated (45.36%) with highest number of calls due to pesticides (18.45%) followed by detergents and corrosives (7%).Drugs (22.49%) mainly comprised of benzodiazepines, analgesics and anticonvulsants. Agricultural pesticides (15.60%) commonly involved organophosphates, pyrethroids, and aluminium phosphide.Industrial chemicals (7.51%) chiefly included copper sulfate. Bites and stings (2.94%) comprised mainly snake bites and plants (2.35%) particularly involved Dhatura. Calls due to unknown and miscellaneous products were few (1.58%, 2.13%). A striking feature of the study was a high incidence of poisoning in children (56.20%), age group mainly affected being less than 6yrs. (73.25%). Conclusions: The results highlight an increasing use of household products and their misuse, stressing the need for implementation of prevention programmes and creating awareness and education about proper use.

Keywords: Household products, intentional poisoning, poisons centre, telephone calls

[TAG:2]TOX – 4: Hepatotoxicity Due to Antituberculosis Drugs:A Case Series [/TAG:2]

Gaurav Jansari, Anil Singh, Kiran Piparva

Department of Pharmacology, PDU Goverment Medical College, Rajkot, Gujarat, India

Introduction: Tuberculosis (TB) is treated by short course chemotherapy (SCC) which is combination of 4-5 drugs and out of which three are hepatotoxic. Hepatotoxicity requires interruption of therapy and thereby have impact on outcome. So current case series we have evaluated for risk factors associated with hepatotoxicity in TB cases. Case Reports: There were nine cases of hepatotoxicity induced by antituberculosis drugs which were confirmed by lab test {Alanine aminotransferase and Bilirubin (Direct and Total)}. Five cases reported within one week of antitubercular treatment and remaining four cases it was reported between one week to five weeks after initiation of therapy. WHO scale of hepatotoxicity is based on rise in the liver enzyme alanine aminotransferase and graded. As per WHO scale five cases are of grade-1 and rest four cases are grade-2. According to American thoracic society guideline, grade-2 patients required withdrawal of antituberculosis treatment but here withdrawal was done only in one case among four cases of grade-2. Concomitant hepatotoxic drug was found only in one case. All the cases were managed symptomatically. Causality assessment of reported adverse reaction were carried out by using WHO UMC criteria which revealed that reactions were “possible” in nature. Results: Malnutrition, low body weight, male gender, geriatric are risk factors in this case series. Conclusion: By knowing risk factors, grade of hepatotoxicity and treatment, we can reduce occurrence of this type of events and minimize the impact which indirectly affects the compliance of antituberculosis treatment.

Keywords: Hepatotoxicity, short course chemotherapy, tuberculosis


  TOX – 5: Potential Contribution of Oxidative Stress Towards Methotrexate Induced Hepatic Dysfunction Top


Banhishikha Adhikari, Srija Moulik, Amrita Sil, Parasar Ghosh, Mitali Chatterjee

Institute of Postgraduate Medical Education and Research, SSKM Hospital, Kolkata, West Bengal, India

Objectives: Disease Modifying Antirheumatoid Drugs (DMARDs) play a pivotal role in the management of rheumatoid arthritis (RA). Methotrexate is commonly prescribed due to its favourable cost-effectiveness profile. Methotrexate can cause elevation in hepatic transaminases, but the underlying pathogenesis remains poorly defined. In animal models receiving methotrexate, liver damage with raised ALT/AST has been attributed to oxidative stress. Accordingly, this study was planned to evaluate the role of oxidative stress, if any, towards the methotrexate-induced hepatic dysfunction in patients of RA. Methods: Patients taking low dose methotrexate (≤25 mg/weekly) for ≥4 weeks and developed transaminitis were included. The parameters studied were their clinico-demographic profile, hemogram, Liver Function Test and generation of reactive oxygen species in neutrophils (NROS). Results: Majority of RA patients (n=20) were middle-aged (42.20 ± 9.69 years), female (80%), literate (90%), married (95%) and of urban residence (70%). All patients received low dose methotrexate and additionally, 5 received leflunomide while 9 received DMARDs (hydroxychloroquine and sulfasalazine). The disease activity was 'mild' and the duration of treatment by DMARDs (40.6 ± 17.64 months), tender (1.8 ± 1.78) and swollen (0.20 ± 0.44) joint count was comparable amongst the three groups. Levels of AST (110.5 ± 98.8 IU/l) was 3 times and ALT (211.9±190.5IU/l) was 6 times higher than normal. Levels of NROS (measured as Geometric mean fluorescence channel) was raised as compared to healthy controls (636.8±623.16 vs. 405.39±393.6) and showed a strong positive correlation with levels of ALT (r=0.767, 95% CI=0.209 to 0.948). Conclusion: Raised liver enzymes were a consistent feature of all patients with RA who received a low dose methotrexate and was accompanied by oxidative stress, suggesting that oxidative stress may contribute towards the hepatotoxicity of methotrexate.

Keywords: Methotrexate, reactive oxygen species, rheumatoid arthritis, transaminitis


  TOX – 6: Pulmonary Protectiv Efficacy of DRDE-07 Analogues Against Sulfur Mustard in Mice Top


Alok Kumar Soni, Bhaskar ASB, Pravin Kumar, Uma Pathak, Kannan GM

Division of Pharmacology and Toxicology, Defence Research and Development Establishment, Gwalior, Madhya Pradesh, India

Objective: Sulphur mustard (SM) is a potent blistering Chemical Warfare Agent and has been widely used during WWI and recently by ISIS terrorist. No suitable antidote is available so far. Lung is also one of the target organs due to inflammation and oxidative stress. The pulmonary protective efficacy of DRDE-07 and its two analogues (DRDE-30 and DRDE-35) against SM induced toxicity were explored. Mathods: The female Swiss mice were orally gavaged with DRDE-07 and its analogues (dose: 0.2 LD50) 30 min before SM exposure. SM (2 LD50; p.c.) was applied on hair clipped darsocaudal region. Animals were sacrificed on day 3 and 7 and bronchoalveolar lavage (BAL) fluid and lung tissue was collected for following biochemical parameters which includes protein level, lactate dehydrogenase (LDH) activity, myeloperoxidase (MPO) activity, MMP-9 gelatinase activity and activated macrophages, reduced glutathione (GSH) level, and lipid peroxidation. Results: A significant increase in BALF protein level, LDH release, MPO and ß-glucuronidase activity after SM exposure compared to controls and these changes were attenuated by DRDE-07 and its analogues. The pretreatment of DRDE-07 and its analogues inhibited the recruitment of inflammatory cells into the lungs tissue and BAL fluid. The decrease in reduced GSH content accompanied with increasing of MDA level in lung tissue indicates oxidative stress induced by SM exposure. The gelatine zymography analysis of BAL fluid suggests a significant increase in matrix metalloproteases (MMP-9) activity due to the inflammatory cells accumulation. Conclusions: Among the analogues DRDE-07 was found to exhibit significant beneficial effect as compared to other two analogues as they showed moderate protective effects. The beneficial effect of DRDE-07 and its analogues attributed to their antioxidant and anti-inflammatory activity. Since there is no single compound approved so far to treat SM induced systemic toxicity, DRDE-07 and its analogues may be considered as candidate molecules.

Keywords: DRDE-07, lung injury, sulphur mustard


  TOX – 7: Hepatoprotective Potential of Camellia sinensis Extract Against Experimental Hepatotoxicity in Rats Top


Anudeep Reddy M, Kala Kumar B, Boobalan G, Kasi Reddy M, Gopala Reddy A

Department of Veterinary Pharmacology and Toxicology, College of Veterinary Science, Rajendranagar, Hyderabad, India

E-mail: [email protected]

Objectives: To evaluate the hepatoprotective effect of Camellia sinensis (Green tea) extract and N-acetyl-L-cysteine in acetaminophen induced hepatotoxicity in rats. Methods: Male Wistar albino rats (n=24) of three months age were equally divided into four groups. Group 1: normal control. Hepatotoxicity was induced in remaining three groups with administration of acetaminophen (APAP) @ 500 mg/kg po from day 1 to 3. Groups 2, 3 and 4 were subsequently administered orally with distilled water, N-Acetyl-L-cysteine (NAC) @ 300 mg/kg and Camellia sinensis extract (CSE) @ 100 mg/kg, respectively for 11 days. Mean body weights and biomarkers of hepatotoxicity were estimated on day 0, 4 (confirmation of toxicity) and 15 (at the end of treatment). Hematological parameters were evaluated on day 4 and 15. Antioxidant profile and ATPases enzyme was assessed at the end of the experiment. Liver tissues were subjected to histopathology and transmission electron microscopy after the sacrifice on day 15. Results: Antioxidant profile, ATPases, hematological and serobiochemical parameters were significantly altered and histopathological changes were noticed in liver of toxic control group. There was significant reversal of pathological alterations in groups 3 and 4 that were administered with N-Acetyl-L-cysteine and Camellia sinensis leaf extract, respectively. Conclusion: The results of the present investigation enunciated that Camellia sinensis extract has significant potent hepatoprotective activity, though N-acetyl-L-cysteine was found superior in restoring the pathological alterations in acetaminophen induced hepatotoxicity in Wistar albino rats.

Keywords: Acetaminophen, Camellia sinensis, hepatotoxicity, N-acetyl-L-cysteine, rats


  TOX – 8: Safety Evaluation of Diethyl-4,4́-Dihydroxy-8,3́-Neolign-7,7́-Dien-9,9́-Dionate (Neolignan1) in Swiss Albino Mice Top


Pankaj Yadav, Arjun singh, Sathish Kumar B1, Hina Iqbal, Arvind S Negi1, Debabrata Chanda

Departments of Molecular Bioprospection and 1Chemistry, CSIR-Central Institute of Medicinal and Aromatic Plants, Lucknow, Uttar Pradesh, India

E-mail: [email protected]

Objective: To study acute and subacute oral toxicity of a novel and bioactive Neolignan1 in Swiss albino mice. Methods: Neolignan1 was found to have potent anticancer and antihypertensive activity in in-vivo models. Hence, neolignan1 was studied in-vivo for acute and subacute oral toxicity in Swiss albino mice following IAEC approved protocols and are in accordance with OECD guidelines. In acute oral toxicity, neolignan1 was given at 5, 50, 300 and 1000 mg/kg body weight as a single oral dose and the animals were observed for 7 days. In subacute oral toxicity, neolignan1was given at 0.1, 1, 10 and 100 mg/kg body weight once orally for 28 days to the experimental mice. All the animals were observed for behavioral, hematological and blood biochemical changes during the experimental period. All major organs were also collected and observed for gross pathological changes. Results: Neolignan1 was well tolerated by the experimental swiss albino mice upto 1000mg/kg in acute oral toxicity and upto 100 mg/kg in subacute oral toxicity. Paramenetrs studied like behavioural changes, hematology, blood biochemical parameters and gross pathology did not show any changes across all the gropus compared to control both in acute oral and sub acute oral toxicity studies. Conclusion: Our present study reports that neolignan1 is well tolerated by the experimental mice upto 1000 mg/kg in acute oral toxicity and upto 100 mg/kg in sub acute oral toxicity with out significant mortality, morbidity, biochemical, hematological and pathological changes.

Keywords: Acute, neolignan1, subacute, Swiss albino mice, toxicity


  TOX – 9: Role of Zinc Supplementation in Methotrexate-Induced Testicular Damage in Rat: Mechanistic Elucidations Top


Krishna Prahlad Maremanda, Jena GB

Department of Pharmacology and Toxicology, Facility for Risk Assessment and Intervention Studies, National Institute of Pharmaceutical Education and Research, S.A.S. Nagar, Punjab, India

Objectives: Recent evidences suggest that disturbance in Zn homeostasis by anti cancer drugs might play a crucial role in reproductive damage. Thus an attempt has been made to decipher the role of Zinc (Zn), in attenuating the reproductive damage induced by methotrexate (MTX). Methods: Biochemical assays for assessing the oxidative stress parameters like MDA and GSH (reduced). Serum Zn levels using fluorescence Zn-estimation kit. Native gel electrophoresis of serum protein and SOD activity gel assay. Histopathological stainings to determine and score the extent of damage. TUNEL assay for assessing DNA damage in testes. Immunohistochemistry and western blot analysis for various protein (PCNA, BCl-2, GPX5, Nm23-H5, Catalase, 3-βHSD and 17-βHSD) localizations and quantifications. Results: After once weekly dose of MTX (5 mg/kg, i.p.) and daily treatment with Zn (3 and 6 mg/kg, i.p.) for four weeks, testes and epididymis of rat were processed to evaluate the toxicity. Serum Zn level were measured and MTX treatment induced several changes in the germ cells. MTX increased the DNA damage as evident by TUNEL assay in the testes, which was attenuated by Zn supplementation. Apart from DNA damage it has also increased the lipid peroxidation and altered the expressions of several antioxidant enzymes like SOD, catalase, nm23-H5 and GPX5. It has also affected the steroidogenic markers like 3-βHSD and 17-βHSD. Conclusion: Considering all these evidences the current study advices the beneficial role of Zn in MTX-induced testicular damage. Further studies are needed to exactly determine the beneficial role of Zn during chemotherapy.

Keywords: Epididymis, GPX5, methotrexate, oxidative stress, testes, zinc


  TOX – 10: An 11 Years Retrospective Study of Poisoning Incidence in Children Reported at National Poisons Information Centre, AIIMS, New Delhi Top


Amita Srivastava, Sharda Shah Peshin, Yogendra Kumar Gupta

Department of Pharmacology, National Poisons Information Centre, All India Institute of Medical Sciences, New Delhi, India

Objectives: Acute poisoning in children due to toxic household substances and medications is an important health issue. The agents causing poisoning, ingested amount, time of availability of appropriate care, awareness and educational status makes it very difficult to ascertain the true extent and burden of poisoning in India. The National Poisons Information Centre (NPIC) is a known Centre in Northern India for providing poisoning information services. The present study was undertaken to analyse poisoning cases in children as reported to NPIC during April 2005-March 2016. Methods: The telephone calls were analyzed with respect to age, sex, route of exposure, mode and type of poisoning. The calls pertaining to children were divided into four age groups (Gp. I: 0-6yrs, Gp .II :> 6-12yrs, Gp. III: >12-16yrs, Gp.IV: >16-18yrs). The agents implicated in poisoning were categorized into eight categories: household products, medicines, agricultural pesticides, industrial chemicals, snake/insect bites, plants, unknown and miscellaneous groups. Results: A total of 16,835 calls on poisonings were received during the study period. There were 9,066 calls on poisoning in children (53.85%). The most susceptible age group was Gp I (73.05%) followed by Gp II (10.45 %), Gp III (8.25 %) and GpIV (8.23%) respectively. Males were more affected than females (M=69.14% F=30.85%). The highest incidence of poisoning was due to household products, followed by the medicines group. Conclusion: The present study highlights that children, below 6 years of age were predominantly affected. Since paediatric poisoning was primarily due to negligence, careless storage, easy accessibility and lack of parental supervision; implementations of preventive measures and education about safe use at home can definitely help in achieving poisons control at home.

Keywords: Accidental poisoning, childhood poisoning, household products, poisons centre, telephone queries


  TOX – 11: Pantoprazole: A Study to Evaluate its Specific Renal Toxicity Top


Shabbir Rafik Pendhari, Ramchandra P Limaye, Kedar S Joshi

Department of Pharmacology, Bharati Vidyapeeth Deemed University, Medical College and Hospital, Sangli, Maharashtra, India

Objectives: Proton pump inhibitors (PPIs) are the most commonly used drugs. Though the PPIs are said to be safer, the adverse drug reaction were reported with its long term use. Acute interstitial nephritis was also observed in patients on PPI in various observational studies. As, PPIs were commonly co-prescribed with NSAIDs or with antimicrobial agents ,also known to cause adverse effect on kidney, we planned study on pantoprazole, aimed to evaluate the effect of pantoprazole on renal function test, IL-18 and renal histopathology. Methods: We administered pantoprazole 10,20and 40mg/kg in rats by orally for 28days. In other group pantoprazole in the same dose and in the same duration along with diclofenac ip or ofloxacin orally for 5 days was administered. Gentamycin ip for 5days was kept as a positive control. RFTs were carried out on 0,7th,14th,21st and 28th day. On 28th day animals were kept in metabolic cadge for 24 hr urine collection. The effect of pantoprazole on IL-18 was also noted down as pre and post-test. After 28th day at least 2 animals with deranged RFTs were scarified for histopathological study of kidneys. Results: Nearly 2-3 animals from each group showed deranged RFTs. Histopathological studies confirms vascular and/or structural changes in kidneys. Significant increase in IL-18 levels was also observed. Conclusion: Pantoprazole alone or along with diclofenac/ofloxacin have an ability to affect the kidney of rats, but for extrapolation in human we require large study data. However the observations suggest a cautious approach in predisposed human subjects.

Keywords: Acute interstitial nephritis, histopathology, IL-18, proton pump inhibitor


  TOX – 12: Evaluation of Caspases Dependent Apoptosis Induced by Chlorpyrifos Pesticide in Peripheral Blood Lymphocytes of Rats Top


Anupama Ojha, Gupta YK

All India Institute of Medical Sciences, Bhopal, Madhya Pradesh, India

E-mail: [email protected]

Organophosphate pesticides (OPs) are among the most useful and diverse classes of pesticides in use for almost five decades. Pesticides induce excessive generation of reactive oxygen species (ROS) and causes damage to all vital macromolecules including lipids, proteins and DNA. Damaged DNA if not repaired or mistakenly repaired, may lead to gene mutations and initiate carcinogenesis. In our previous study we have reported that chlorpyrifos (CPF), an organophosphate pesticide have genotoxic potential. The objective of this study is to investigate if the selected pesticide induces apoptosis or not. Peripheral blood lymphocytes of rat were exposed to ¼ and 1/10 LC50 concentration of chlorpyrifos for 2, 4, 8 and 12h. Lipid peroxidation was measured as the marker of induction of oxidative stress. Caspases (caspase-3 and caspase-9) activity was determined by measuring the levels of released AMC using a spectrofluorometer with excitation at 380 nm and emission at 460 nm. A time-course study showed that CPF significantly increase the level of caspases suggesting their potential to induce apoptosis. However further study is needed to make any conclusion.


  TOX – 13: A Study on Knowledge, Attitude and Practice of Fixed Dose Combination Prescription Among Post Graduates in A Tertiary Care Hospital Top


Mamatha Reddy Dundigalla, Venkata Siva Prasadu M, Shireesha G, Sharon Sonia S, Vijaya Bhaskara Reddy Y

Background: Fixed Dose Combination (FDC) is a combination of two or more pharmaceutically active ingredients in a fixed ratio of doses, to make a single dosage. Despite being highly useful, irrational combinations and prescription of FDC's is an important public health concern. Objective: To evaluate knowledge, attitude and practice of FDC prescription among the postgraduates in a tertiary care hospital, Government General Hospital, Kurnool. Materials and methods: The study was carried out among post graduate doctors of Government General Hospital, Kurnool a tertiary care teaching hospital. All the post graduates from all the deparments of the hospital, who gave their informed consent, were enrolled. A prevalidated questionnaire regarding knowledge, attitude and prescribing practice of fixed dose combinations was filled up. Data was analyzed with suitable statistical tests. Results: Pending.

Keywords: Essential medicine list, fixed dose combination, knowledge, aptitude and practice, postgraduates


  GIT (GASTROINTESTINAL PHARMACOLOGY) Top



  GIT – 1: Hepatoprotective Activity of Cynodon dactylon on Paracetamol Induced Albino Rats Top


Heikham Chandani Devi, Kh Krishna Pramodini Devi

Department of pharmacology, Regional Institute of Medical sciences, Imphal, Manipur, India

Objectives: To study the effect of aqueous extract of Cynodon dactylon on hepatic enzymes in albino rats. India has tremendous wealth of medicinal plants and its resources which are of different kinds they grow in different climatic and ecological conditions. In ancient time India was not so advanced in therapeutic values of medicinal plants. Cynodon dactylon is hardy, perennial grass, very variable with long rapid growing, creeping runner, rooting at nodes, forming a spreading mats on the surface of the soil. It is abundant on the road side and paths, uncultivated land. According to old venda tradition, it is used as antiseptic, diuretic. It is also reported to use in anasarca, calculus, cancer, carbuncles, convulsions, cough, cramps, cystitis, diarrhoea, dysentery, headache. Family: poceae, Species: Cynodon dactylon (L.) pers. Genus: Cynodon Also called- English: creeping panic grass, couch grass, Bermuda grass. Hindi: Doob, Dub, Dubra, Khabbal, Kaligas.Manipuri: Tingthou. Methods: The study was conducted in the Dept. of pharmacology, RIMS, Imphal. The animals were taken from the central animal house, RIMS. The aqueous extract of aerial parts of Cynodon dactylon was obtained by Verma SCL and Aggrawal SL. The extract thus obtained was investigated for hepatoprotective effect on serum enzyme leves. For this method, albino rats of 5 groups of 6 animals each were taken. At the end of 72 hour, blood was collected by retro-orbital puncture and serum was separated and estimated for alkaline phosphatase (ALP), SGOT, SGPT. Results: The hepatoprotective activity of aqueous extract of Cynodon dactylon is shown below, Values are mean SEM, #P<0.05 when compared to toxic group Conclusions: The present study shows that aqueous extract of Cynodon dactylon has hepatoprotective activity. Further studies will have to be carried out to find out the active principle responsible for hepatoprotective ctivity.

Keywords: Cynodon dactylon, hepatoprotective, N-acetylcysteine, paracetamol.


  GIT – 2: Antioxidant and Gastro-Protective Effects of Fruits of Piper nigrum Linn (Black Pepper) In Wistar Albino Rats Top


Medhi N, Ray RP, Gogoi G

Department of Pharmacology, Jorhat Medical College and Hospital, Jorhat, Assam, India

E-mail: [email protected]

Objective: The study aims to evaluate the Antioxidant and Gastro-protective effects on Albino rats by the alcoholic extract of fruits of Piper nigrum Linn (Black Pepper). Material and Methods: An experimental study is going on Piper Nigrum Linn in the departmental lab using Wistar Albino rats as the experimental animal, following clearance from the IAEC. The study aims to see the Antioxidant and Gastro-protective action of ethanolic extract of fruits of Piper Nigrum Linn (Black pepper) and to compare it with that of drugs which is commonly in use; in this study we are using Ranitidine as the standard drug for gastro protective action while Vit-C is used as antioxidants. Then after 14 days one group of experimental feeding we sacrifice the rat and look for the gastric ulcer size along with pathological confirmation of the ulcer and gastric acid estimation of the stomach of the rats. The other group is fed with Vit-C and piper nigrum Linn after 21 days are test for antioxidant level in the blood using colorimeter method of estimating plasma TBA. Results: Results awaited. Conclusions: We hope to find comparable gastro-protective and antioxidant activity of Piper Nigrum Linn with that of standard drugs in use.

Keywords:Antioxidant, gastro-protective, Piper nigrum Linn., TBA


  GIT – 3: Bisphosphonates in the Management of Inflammatory Bowel Disease Associated Low Bone Mass: A Metaanalysis Top


Phulen Sarma, Ajay Prakash, Avishek Mishra, Rakesh Ruhela, Shringika Soni, Bikash Medhi

Department of Pharmacology, PGIMER, Chandigarh, India

Background and Aims: Patients suffering from inflammatory bowel disease (IBD) are at increased risk for low bone mass and related complications. Bisphosphonates are commonly used for management of osteoporosis. In this metaanalysis we are trying to evaluate the effect of bisphosphonates in management of low bone mass and associated complications in patients with IBD. Methods: We searched different databases like MEDLINE, Google scholar, Cochrane registry of clinical trials, EMBASE for relevant randomized clinical trials involving bisphosphonate as an intervention arm with disease condition (Inflammatory bowel disease, ulcerative colitis and Crohn's disease) AND low bone mass (osteopenia, osteoporosis). Primary aim was change in BMD in lumbar spine. Results: We analyzed data from 12 studies involving use of bisphosphonates. Pooled effect of bisphosphonates was greater than pooled effect of controls with regards to increasing BMD at lumbar spine. Conclusions: We conclude that bisphosphonates are effective in treatment of low bone mass associated with inflammatory bowel disease.


  ENDO (ENDOCRINE PHARMACOLOGY) Top



  ENDO – 1: Anti-Diabetic and Reno-Protective Action of the Ethanolic Extracts of Andrographis paniculata Leaves in Albino Rats Top


Bakal B, Chaliha M

Department of Pharmacology, Jorhat Medical College and Hospital, Jorhat, Assam, India

E-mail: [email protected]

Background: Diabetes mellitus (DM) refers to a group of common metabolic disorders that share the phenotype of hyperglycemia. Nephropathy is one of the most common diabetic microvascular complications. Over the past few years the use of indigenous drugs has been on the rise along with the modern system of medicine due to its lesser known side effects. Objectives: Andrographis paniculata originates from India and grows widely in many areas in Southeast Asian countries and has been used traditionally for Diabetes. The present study is aimed at evaluating the ethanolic extract of the plant for anti-diabetic and reno-protective actions in albino rats. Materials and Methods: The study was conducted in the Department of Pharmacology, Jorhat Medical College, Assam after due permission from Institutional Animal Ethics Committee (IAEC). A single intra-peritoneal injection of 60 mg/kg Streptozocin, 15 min after the i.p. administration of 120 mg/kg of Nicotinamide was used for induction of Diabetes. Gentamicin (80mg/kg) was injected i.p for 8 consecutive days for induction of nephrotoxicity. Anti-diabetic activity was measured by estimating the fasting blood glucose levels and other parameters such as change in body weight. Reno-protective action was measured by estimating serum creatinine, Blood Urea, Blood Urea Nitrogen and Urine volume. Results: The purified ethanolic extract significantly (P<0.05) decreased the levels of blood glucose, body weight, creatinine, blood urea, BUN and urine volume compared to controls. The standard drugs Glimipride and N-Acetylcysteine also showed similar results. Conclusions: Keeping in view the present orientation towards indigenous drug development and wide prevalence of diabetes along with nephropathy further study can be done to develop a potential drug which will be less expensive, less toxic, commonly available and at the same time efficacious.

Keywords: Andrographis paniculata, diabetes, gentamicin, nephrotoxicity, nicotinamide, streptozocin


  ENDO – 2: Evaluation of Prophylactic Effect of Herbal Formulation -Nishamalaki In Streptozotocin and High Fat High Fructose Diet Induced Diabetes and its Complications Top


Jaycee Dawane, Vijaya Pandit, Pallawi Khatavkar, Madhura Bhosale

Department of Pharmacology, Bharati Vidyapeeth Deemed University Medical College, Pune, Maharashtra, India

E-mail: [email protected]gmail.com

Objectives: Nishamalaki, combination formulation of Curcuma longa and Emblica officinalis used for Diabetes in ayurveda.We assessed the time required for development of diabetes and its complication with Streptozotocin (STZ) & High Fat High Fructose (HFHF) diabetic model and evaluated Nishamalaki for prophylactic, Therapeutic efficacy and effectiveness in diabetic complication. Methods: Diabetes induced in 66 rats with STZ 35mg/kg i.p + Followed by HFHF Diet till the development of Diabetes. Part I- Nishamalaki started with STZ,( N= 25) either sex compared with control rats. Part II- 36 Diabetic rats of either sex, randomly allocated to different groups (n=6). Groups I- vehicle, II- Diabetic Control, III-Nishamalaki ( 0.9 gm/kg), IV-Nishamalaki (1.8 gm/kg), V- Glibenclamide , VI- Pioglitazone and treated for 8 wks. Body weight, Blood sugar (BSL) & Lipid profile measured. Observed for complications for further 8months. Statistical Analysis done with NOVA. Results: Part I- Persistent increased levels of BSL obtained in14 days. Nishamalaki achieved Significant (p<0.01) lowering of blood glucose and reduced serum cholesterol, triglycerides and LDL compared to diabetic control. Part II - Significant reduction in BSL observed in NA-LD (p<0.05) & Glibenclamide (p<0.01). Results of NA-HD were comparable to Pioglitazone. Serum Cholesterol levels significantly decreased in NA-LD (p< 0.001) & NA-HD (p< 0.01) than diabetic contol. NA-LD, Glibenclamide & Pioglitazone were equal in reducing triglycerides (p< 0.01). HDL levels increased with NA-HD (p<0.001). Conclusions: Nishamalaki has major prophylactic value & Corrected lipid imbalance. Nishamalaki delayed development & progression of cataract,nephropathy & neuropathy.

Keywords: Blood sugar, lipid profile, prophylactic


  ENDO – 3: Evaluation of Anti Diabetic and Hypolipidemic Property of Ethanolic Extract of Tender Leaves of Nyctanthus arbor-Tristis in Experimental Animals Top


Dr.Syed Adam Mousum, Dr. Mangala Lahkar

Department of Pharmacology, Gauhati Medical College and Hospital, Guwahati, Assam, India

Objectives: This study was undertaken with the objective of studying the antidiabetic and hypolipidemic property of ethanolic extract of tender leaves of nyctanthus arbor-tristis in experimental animals.

Materials and Methods: Diabetes was induced by a single dose of Streptozotocin (50 mg/kg i.p.) in citrate buffer. Antidiabetic activity of Nyctanthus arbus tristis was then evaluated at doses 100mg/kg, 200mg/kg and 400mg/kg and compared with a standard which was gilbenclamide. Blood glucose level was determined to assess anti-diabetic effect. Hyperlipidaemia was induced in rats by a cocktail diet containing cholesterol, peanut oil, cholic acid and propylthiouracil. Hypolipdaemic activity of Nytanthus arbus tristis was then evaluated at doses 100mg/kg, 200mg/kg and 400mg/kg and compared with a standard, Atorvastatin. Total cholesterol, triglycerides, HDL, LDL and VLDL were determined to assess the hypolipidaemic effect. Observations: The extract produced significant reduction in blood glucose level at doses of 200mg/kg and 400 mg/kg as compared to Diabetic Control group. Glucose lowering activity of both the doses of the extract were found to be lower than the standard drug, Glibenclamide. Ethanolic extract of the leaves of Nyctanthus arbus tristis showed significant hypolipidaemic effect at all the doses but the effect was highest with 400mg/kg dose. There was significant reduction in the levels of total cholesterol, triglycerides, LDL and VLDL compared to the hyperlipidaemic control group. Conclusions: From the above results it can be concluded that the ethanolic extract of the tender leaves of Nyctanthus arbus tristis possessed significant antidiabetic and hypolipidaemic activity but further studies are required to understand the exact mechanism of the effects.

Keywords: Hyperglycaemia, hyperlipidaemia, Nyctanthus arbus tristis, streptozotocin


  ENDO – 4: Serum Vitamin B12 Levels in Metformin Treated Type 2 Diabetic Patients: A Cross-Sectional Study Top


Shraddha M Pore, Arundhati T Salunke, Sunita J Ramanand

Department of Pharmacology, Government Medical College, Miraj, Maharashtra, India

Objectives: To measure serum vitamin B12 levels and assess prevalence of vitamin B12 deficiency in metformin treated diabetic patients. Methods: This cross-sectional study was conducted at tertiary care hospital during the period of February 2016-June 2016. All patients ≥ 18 years age of either gender diagnosed with Type 2 Diabetes Mellitus and receiving metformin treatment ≥ 1 year, giving written informed consent to participate were included in the study. Vitamin B12 assay was done by mini VIDAS, a compact automated immunoassay system based on the Enzyme Linked Fluorescent Assay (ELFA) principles. Vitamin B12 level of ≤200pg/ml was considered as absolute deficiency, while vitamin B12 level in the range of 200-240pg/ml was considered as borderline deficiency. Results: Forty-eight type 2 diabetic patients receiving metformin were enrolled in the study. Thirty-two (66.66%) were males and 16 (33.33%) were females patients. Food habbits were lacto-veg in 18 (37.5%) and 30 (62.5%) were on mixed diet. Twenty-seven (56.25%) patients were on metformin monotherapy and 21 (43.75%) patients were on combination therapy of metformin and glimepride. Mean duration of both diabetes mellitus and metformin therapy was 5.792 ± 5.609 years. Twenty-three (47.91%) patients had associated hypertension. Neuropathy was seen in 12 (25%) patients. Absolute vitamin B12 deficiency was observed in 04 (8.33%) patients and borderline vitamin B12 deficiency was seen in 02 (4.16%) patients. Conclusion: Most of patients receiving metformin therapy had vitamin B12 levels in normal range.

Keywords: Diabetes mellitus, metformin, Vitamin B12


  ENDO – 5: Study of Zinc in Diabetic Neuropathy as an add on Therapy Top


Saurabh S, Sharma S, Sharma A, Jain A, Maurya M

Department of Pharmacology, SNMC, Agra, Uttar Pradesh, India

Objective: To observe the effect of zinc as add on therapy in diabetic neuropathy along with observation of its side effects.Materials and Methods: A total of 100 patients of diabetic neuropathy were evaluated prospectively in two groups.Group A(n=50): Standard antidiabetic therapy (Pregabalin 75mg+methylcobalamin 1500mcg) Group B(n=50): Standard antidiabetic therapy (Pregabalin75mg+methylcobalamin 1500mcg) with ZINC(50mg/day) as add on therapy. Regular follow up & assessment on parameters of clinical examinations, blood sugar, lipid profile & nerve conduction studies was done. Results: Analysis using chi square and paired unpaired t test was done. The Group B was observed to show a statistically significant(p<0.05) decline in symptoms of hypoesthesia(88% to 52%), paraesthesia(90% to 54%), cramps and pain(50% to 34%) at end of 6 month add on zinc therapy. A decline from 44% to 22% was observed in parameter of resting tachycardia. Better control of blood glucose(135.76 to126.22g/dl), TGA (220.06 to196.56), and LDL(158.98 to152.88) were observed in study group B vs. control group A blood glucose(137.14 to130.36), TGA(221.56 to213.94), LDL(159.3 to153.7). HDL levels increased more in group B(45.12 to48.06) vs.group A (48.82 to51.44). Statistically insignificant improvement is observed in nerve conduction studies of common peronealand median nerve. Gastric upset was observed s/e in 12% patients. Conclusions: Zinc supplementationshows significant improvement in signs and symptoms of diabetic neuropathy.

Keywords: Antidiabetic, blood glucose, hypoesthesia


  ENDO – 6: Aqueous-Ethanolic Extract of Costus Specious Leaves Has Hypoglycemic, Insulin Secretogogue, Anti-Dyslipidemic and Nephro-Protective Effects in Type-2 Diabetes Mellitus Model of Wistar Rats Top


Natesh Prabhu, Sheetal Ullal1, Sushma DS2, Sanjay Hadigal3, Ashok Shenoy1

Department of Pharmacology, Dhanalakshmi Srinivasan Medical College and Hospital, Perambalur, Tamil Nadu, 1Department of Pharmacology, Kasturba Medical College, Manipal University, Mangalore, 2Department of Pharmacology, Khaja Bandanawaz Institute of Medical Science, Gulbarga, Karnataka, India

Objective: To evaluate the hypoglycemic,hypolipdemic and anti-oxidant activity of aqueous–ethanolic extract of Costus Speciosus(CS) leaves in type-2 diabetes mellitus(T2DM) model of wistar rats. Materials and Methods: T2DM was induced in four groups of six rats each by administering nicotinamide(75mg/kg) dissolved in freshly prepared normal-saline,followed 20 minutes later by streptozotocin(50mg/kg) dissolved in freshly prepared 0.1M citrate-buffer at pH4.5.The diabetic rats were randomly assigned to diabetic-control group(DC) which was treated with vehicle(1% carboxymethylcellulose,10ml/kg),glibenclamide group(GC) receiving glibenclamide(600μg/kg) and two test-groups receiving aqueous–ethanolic extract(Soxhlation) of leaves of CS 200mg/kg(CSA200) and 400mg/kg(CSA400) respectively for 30 days. Normal-control group(NC) was injected with citrate-buffer and fed 1% carboxymethylcellulose. Pretreatment and post-treatment Fasting Blood Glucose(FBG) was measured. On day-30,blood from anaesthetized animals was collected by cardiac puncture and serum was analyzed for lipid profile and insulin assay. Liver,kidney(homogenized) and pancreas(alcohol-fixed) from euthanized rats were sent for glycogen estimation,oxidative-stress markers assay(MDA/GSH) and histopathological examination respectively. Data were analyzed using SPSS-ver.16,by one-way ANOVA followed by Tukey test for intergroup analysis and paired t-test for intragroup analysis. Results: CS at 200 and 400mg/kg and glibenclamide significantly reduced FBG compared to DC-group(p<0.0001).There was a significant increase in serum insulin(p=0.105,p≤0.00001),liver glycogen(p=0.112,p=0.03),HDL-C(p=0.24,p≤0.00001) and MDA(p≤0.00001,p≤0.00001) levels and decrease in Total-Cholesterol(p=0.212,p=0.374),Tri-Glycerides(p≤0.00001,p≤0.00001) and GSH(p=0.021,p=0.001) levels in CSA200 and CSA400 groups respectively when compared with DC-group. Histopathological examination of pancreas showed islet-cell regeneration in CSA200 and CSA400 groups. Conclusions: The aqueous–ethanolic extract of CS leaves has a dose-dependent hypoglycemic, insulin-secretogogue, anti-dyslipidemic and nephro-protective activity in T2DM model of wistar rats.

Keywords: Costus Speciosus, streptozotocin-nicotinamide, Type-2 diabetes mellitus


  ENDO – 7: A Randomized, Open Labelled, Parallel Group, Comparative Study of Safety and Efficacy of Vildagliptin Versus Glimepiride as add on Therapy In Patients with Uncontrolled Type 2 Diabetes Mellitus on Metformin in a Tertiary Care Hospital Top


VijaySubba Raju P, Annapurna D, Usha Kiran P

Department of Pharmacology, Rangaraya Medical College, Kakinada, Andhra Pradesh, India

Objectives: To compare the safety and efficacy of Vildagliptin andGlimepiride as add-on therapy to Metformin in patients with type-2 diabetes mellitus by measuringglycemic control parameters like fasting blood glucose, 2-hour postprandial glucose and reduction in HbA1c levels at week 12 from baseline and considering the development of side effects in patients on Vildagliptin-Metformin therapy versus those on Glimepiride-Metformin therapy.Materials and Methods: This comparative study was conducted on 60 Type-2 Diabetes Mellitus patients at Government General Hospital,Kakinada. 30 patients were given Vildagliptin-Metformin and other 30 patients were given Glimepiride-Metformin. Blood sugar levels,HbA1c were measured and the data was analyzed using SPSS version 22. Results: In this study from baseline to the 12 week endpoint there is comparable reduction in HbA1c with a mean±standard deviation of 1.39±0.46 in Vildagliptin group and 1.12±0.32 in the glimepiride group(p=0.02) A similar reduction in 2h-PPG was observed, and the diminution in FPG (Vildagliptin group 32.8±10.1 mg/dl vs. glimepiride group 29.6±1.9 mg/dl were not different between groups with a p value 0.12. In glimepiride group there is an average weight gain of 2.26±1.10 kg in distinction to Vildagliptin group where it shown weight loss of 0.12±0.56 from baseline. Conclusions: HbA1c control was better in Vildagliptin-Metformin group and incidence of hypoglycemia was less. Vildagliptin–Metformin combination led to weight loss whereas Glimepiride-Metformin combination led to weight gain.

Keywords: Diabetes Mellitus, glimepiride, HbA1c, metformin, vildagliptin


  ENDO – 8: Insulin Secrectagouge Potential of Garcinia indica, Barringtonia acutangula and Feronia elephantum Fruit Extracts in Experimentally Induced Diabetic Rats Top


Nayeem A Khatib, Patil PA1

Department of Pharmacology, KLE University College of Pharmacy, 1Department of Pharmacology, KLE-USM School of Medicine, Belagavi. Karnataka, India

Objective: The aim of the present study is to explore the antidiabetic activity of different fruits viz B. acutangula (BA), G. indica (GI) and F. elephantum (FE) extracts, since these fruits are widely used by the local traditional healers to treat diabetes mellitus in the rural areas. Methods: Three extracts viz. aqueous (AqE) methanol (MeOHE) and chloroform were prepared by using whole ripe fruits to evaluate their hypoglycemic activity in euglycemic and streptozotocin (STZ) induced diabetic Wistar rats. Based on the results, activity guided extracts in the dose 400 mg/kg twice a day for 30 days were administered both in euglycemic and STZ induced hyperglycemic rats in a month long chronic study, with respect to their effect on diabetes related parameters viz. serum insulin, HbA1c, hepatic, muscle glycogen content, serum lipid profile and serum biomarkers. Results: BA-AqE, GI-AqE and FE-MeOHE showed significant (P<0.001) antidiabetic effect as evidenced by reduction of blood glucose, increase in serum insulin level, glycogen content in liver and muscle, G6PD, antioxidant biomarkers whereas significant (P< 0.001) decrease in HbA1c and correction of dyslipidemia. Conclusions: By virtue of their phytoconstituents like flavonoids, saponins, tannins etc., these extracts increased activity of hepatic antioxidant enzymes like SOD, CAT, GSH, suppression of lipid peroxidation (MDA) and significant (P<0.001) increase in G6PD demonstrating their strong antioxidant potential. Scavenging of the free radicals leading to arrest/decrease oxidative stress on pancreatic β-cells and thereby restoration of normal insulin secretion. These proposed effects of these extracts need to be confirmed by clinical studies.

Keywords: Barringtonia acutangula, diabetes mellitus, Feronia elephantum, Garcinia indica


  ENDO – 9: A Prospective and Observational Study of Effect of Insulin on Cognitive Function in Patients of Diabetes Mellitus in a Tertiary Care Hospital. Top


Dharna Patel, Dhruv Patel, Jayant Rai, Kantharia NS, Amit Gamit1

Departments of Pharmacology and 1Medicine, Government Medical College, Surat, Gujarat, India

Objectives: Insulin therapy is chronic one. In any chronic therapy evaluation of cognitive function is sometimes justified as it may affect various common day to day activities. Opinions regarding insulin and its effect on cognitive function are divided. It is worth to explore any effect of insulin on cognitive function as there is strong possibility of decline in cognitive function in Diabetes Mellitus. Methods: It is a prospective, observational and non-interventional study. 60 Diabetics both type 1 and type 2 who were recently started on insulin (within 7 days) by department of medicine were enrolled in the study based on inclusion and exclusion criteria. FBS, PPBS and RBS were done) at the time of enrollment and after 1 and 3 months of insulin treatment. Cognitive function was assessed by Addenbrooke's Cognitive examination III (ACE-III) at the time of enrollment and after 1 and 3 months of insulin treatment. ACE III is a globally accepted cognitive test which assess five cognitive domains namely attention, memory, verbal fluency, language and visuospatial abilities. Results: Results were analysed by one way analysis of variance. Insulin treatment showed significant improvement in glycemic control. Insulin treatment irrespective of type of diabetes mellitus showed significant improvement in memory, attention, language and visuospatial abilities, whereas there was also change in verbal fluency but it was not statistically significant. Conclusions: This study concludes that Insulin treatment significantly improves cognitive function. The possible mechanism for this improvement in cognitive function may be due to improvement in glycemic control or may be due to action of insulin in brain.

Keywords: Cognitive function, diabetes mellitus, insulin


  ENDO – 10: Effect of Metformin on Lipid Profile in Type 2 Diabetes Mellitus Patients Top


Dhruv Patel, Chetna Patel, Dharna Patel, Kantharia ND, Mahesh Solu1

Departments of Pharmacology and 1Medicine, Government medical college, Surat, Gujarat, India

Objectives: Diabetes mellitus is extremely common global health problem. Dyslipidemia is an independent risk factor for severe morbidity and mortality in terms of cardiovascular risk in type-2 DM patients. There are various studies indicating link between metformin treatment and lipid profile in type 2 DM with most studies suggesting hypolipidemic action independent of hypoglycaemic action which may be helpful to prevent cardiovascular complication. The present study was designed to check the effect of metformin on lipid profile. Methods: The study was prospective, observational and non-randomized. Fifty newly diagnosed Type 2 DM patients selected for metformin therapy by medicine personnel were enrolled in the study based on inclusion and exclusion criteria. Serum Total cholesterol, Triglycerides, HDL, LDL & VLDL were measured at the time of enrolment. Then all enrolled patients were maintained on metformin 500 mg OD for 6 weeks. At the end of 6 weeks again all five parameters were measured. Results: The results were analysed using Paired t-test. After 6 weeks of treatment with metformin; serum cholesterol(P=0.03), triglyceride(P=0.01) & VLDL(P=0.01) were significantly decreased; whereas change was also observed in HDL(P=0.7) & LDL(P=0.1) but was not statistically significant. Conclusions: Treatment with metformin in newly diagnosed type 2 DM has shown significant decrease in serum cholesterol, triglyceride, VLDL. Thus it may reduce need for lipid lowering drugs for cases of borderline hyperlipidemia.

Keywords: Lipid profile, metformin, type 2 diabetes mellitus


  ENDO – 11: Medicinal Plants in Management of Male Infertility: Role of Curculigo orchioides in Deltamethrin Induced Reproductive System Impairment in Wistar Rat Top


Poonam Sharma, Rambir Singh1

Department of Zoology, Indira Gandhi National Tribal University, Amarkantak, Madhya Pradesh, 1Institute of Biomedical Sciences, Bundelkhand University, Jhansi, Uttar Pradesh, India

Exposure to xenobiotics, especially pesticides, is a proven factor in impairment of reproductive function in animals including humans. Deltamethrin (DLM) is a synthetic pyrethroid pesticide used in household and veterinary pest management programmes. Recent reports have shown reproductive toxicity of synthetic pyrethroids affecting normal reproduction and male sexual function and fertility in laboratory animals. 'Vajikaran' is a branch of Ayurvedic Materica Medica for potentiating male fertility and improving sexual performance. Some of the reproductive system enhancer plants are Asparagus racemosus, Mucuna pruriens, Withania somnifera, Astercantha longifolia,Tribulus terristris and Curculigo orchioides. Curculigo orchioides (CO) known as 'Kali Musli' is known to improve ,ale reproductive function and fertility. In the present study ethanolic extract of CO was evaluated against DLM induced reproductive toxicity in male rats. DLM treatment caused significant reduction in body weight, reproductive organ weight, sperm head count, sperm motility, Glutathion (GSH), Catalase (CAT), Superoxide Dismutase (SOD), Glutathion S Transeferse (GST), Glutathion peroxidase (GPx), Glutathion reductase (GR), Testosterone (T), Follicles stimulating hormone (FSH), Luteinizing hormone (LH), and steroidogenic enzyme 3 β Hydroxysteroid dehydrogenase (3β HSD), 17 β Hydroxysteroid dehydrogenase (17β HSD) and disturbed testes histo- architecture. Treatment with CO improved these parameters. DLM causes reproductive damage in male Wistar rats resulting in decrease in reproductive function. CO efficiently improves the reproductive function chiefly by increasing the level of important steroidogenic enzymes and testosterone.


  ENDO – 12: Study of antidiabetic effect of Carissa carandas in Rats and Mechanism of its Insulin Secretagogues activity in Isolated Pancreatic Islets Top


Rambir Singh, Poonam Sharma1

Institute of Biomedical Sciences, Bundelkhand University, Jhansi, Uttar Pradesh, 1Department of Zoology, Indira Gandhi National Tribal University, Amarkantak, Urrat Pradesh, India

Carissa carandas (CC) has been documented as a traditional treatment for diabetes. In the present study, the CC fruit aqueous, methanol, chloroform and ethyl acetate extracts were examined for hypoglycemic activity in healthy Wistar rats. Aqueous Extract of CC (AECC) showed highest fall of 67.08% in fasting blood glucose from 0 to 1h in glucose tolerance test. The ED50 of AECC was 300mg/kgbw in streptozotocin induced diabetic rats. Treatment of diabetic rats with ED50 of AECC for 28 days significantly reduced PPG by 33.65% (p<0.01), HbA1c by 45.79% (p<0.01) and increased insulin level by 69.7% (p<0.05). The increase in insulin secretion may be partly responsible for antidiabetic effect of AECC. To assess the mechanism of secretagogues activity, AECC was incubated with isolated pancreatic islets of Wistar rats at basal (3.3mM) and high (16.7mM) level of glucose in presence or absence of Diazoxide (K-ATP channel opener), Nimodipine (Ca2+ Channel blocker) and Calphostin-C (PKC inhibitor). AECC induced insulin secretion at 16.7mM of glucose was significantly (p<0.01) reduced by Diazoxide and Nimodipine but non significantly (p>0.05) by Calphostin-C. The study indicated that the phytochemicals present in AECC may be inducing insulin secretion by closing K-ATP channels in β-cells of pancreatic islets.

Keywords: Antidiabetic, Carissa carandas, insulin secretion K-ATP channels, wistar rats


  ENDO – 13: Challenges Faced and the Effect of Education on Insulin Use and Glycemic Control in Type 1 Diabetes Mellitus: A Mixed Methods Study Top


Dhiraj RS1, Bantwal G2, George B2, George N3, Xavier D1,3

1Department of Pharmacology, St.John's Medical College, 1Department of Endocrinology, St.John's Medical College Hospital, 2Division of Clinical Research and Training, St.John's Research Institute, Bengaluru, Karnataka, India

Objectives: Among type 1 diabetes mellitus patients to understand the challenges faced and to evaluate the effect of systematic patient education on insulin use and self care on hypoglycemic episodes at 24 weeks. Materials and Methods: We conducted a qualitative study (in-depth interviews) among 11 participants to identify barriers to optimal care and develop strategies for better self-care. We then conducted an open labeled, randomized controlled trial. Eligible patients were >8 years of either sex. The interventions were detailed systematic patient education with a diary at baseline and either face to face or by regular telephonic/ personal visits every two weeks for 24 weeks. These patients received personalized care by a doctor, education on topics of self-care, diet, physical activity, carbohydrate counting and insulin dose modification. Patients in the usual care group received standard advice from the treating doctor and recorded hypoglycemic episodes in a simple diary. The number of symptomatic hypoglycemic episodes were noted in a patient diary at every follow-up visit. Results: Among 32 participants, mean (SD) age was 18 (± 6.3) and 62.5% were female. 26% had thyroid abnormalities. Most common hypoglycemic symptom at baseline was sweating (84%). 96% were on multiple daily injection regimen and median (Q1-Q3) insulin dose/ kg is 1 (0.85-1.19). 56% had poor physical activity. Median (Q1-Q3) number of weeks monitored [intervention, 6 (5-11) vs control, 5 (4-7.5)]. Median (Q1-Q3) number of symptomatic hypoglycemic episodes per week intervention vs control [2(1.5 - 4) vs 2(1.2 - 2.5), p = 0.345]. Conclusion: This study determined the feasibility of testing an educational intervention on the number of symptomatic hypoglycemic episodes and showed no difference between the intervention and control group

Keywords: Challenges, education, hypoglycaemia, insulin use, type 1 diabetes mellitus


  ENDO – 14: Pattern and Extent of Medication Adherence in Patients with Type 2 Diabetes Mellitus: A Prospective Observational Hospital Based Study Top


Annalakshmi J1, Chanda Kulkarni1, Rajni Rathore1,2, Ganapati Bantwal3

Departments of Pharmacology and 3Endocrinology, St. John's Medical College, Bengaluru, Karnataka, 2Department of Pharmacology, AIIMS, Raipur, Chhattisgarh, India

Aim: To evaluate pattern of anti-diabetic medication use and adherence to them among patients with type 2 diabetes mellitus (DM). Materials and methods: This was a prospective study carried out among patients with type 2 diabetes mellitus [DM T2]. The pattern of medication use was recorded in a structured case record form [CRF] and extent of adherence was evaluated using validated self-administered questionnaire (SAQ). Patients' Knowledge Attitude and Practice (KAP) towards their illness and mediations were evaluated using KAP questionnaire. Data on categorical variables were compared using Chi-square (χ2) test and continuous variables using Student's t-test and ANOVA. The significant variables in univariate analysis were entered into multiple logistic regression model to identify determinants of adherence. Significance was set at p < 0.05. Results: Of the 306 eligible patients who completed the study, nos. [55.9%] were males. Patients had a mean (±SD) age of 56.39 (11.9) years. The mean (±SD) of HbA1C levels of patients was 8.39 (1.97), 68.5% had high values (> 7.0) and 37.5% had normal values (≤ 7.0). Metformin was prescribed in nos.(34.94%) and insulin in nos.(30.82%). Insulin use [OR=1.82, CI=1.08, 3.06, P=0.02] and poor KAP scores [OR=5.3 CI=2.7, 10.4, P< 0.0001] were significant predictors of medication non-adherence. Conclusion: The findings suggest non - adherence being associated with poor KAP scores and increased insulin use. Therefore there is need for educational intervention for patients and their care takers to improve knowledge emphasize importance of adherence and focused education about insulin therapy may help to improve outcomes.

Keywords: Anti-diabetic medications, KAP, medication adherence, type 2 diabetes


  ENDO – 15: A Single Blind Randomized Cross Over Study of Nateglinide versus Voglibose in Combination with Metformin in Type 2 Diabetes Mellitus Patients Top


Poojitha KP, Siva Prasad KV, Usha Kiran P, Tirumala Rao MVV1

Departments of Pharmacology and 1General Medicine, Rangaraya Medical College, Kakinada, Andhra Pradesh, India

Objective: To study efficacy and safety of voglibose versus nateglinide with metformin in type 2 diabetes mellitus patients. Materials and Methods: This is a single blind prospective cross over study conducted in General Medicine out patient department, GGH, Rangaraya Medical College, Kakinada, A.P. Study population included patients who fulfilled inclusion criteria and randomly allocated into 2 groups. One group received nateglinide(60mg) and metformin (500mg) BD for 12 weeks followed by voglibose(0.2mg) and metformin(500mg) BD for next 12 weeks(NV group). Another group received voglibose(0.2mg) and metformin(500mg) BD during first 12 weeks followed by nateglinide(60mg) and metformin(500mg) BD for next 12 weeks(VN group). HbA1c levels and post prandial blood sugar (PPBS) levels are measured before study, at 12 weeks and 24 weeks. Values are compared using Student t test. Results: At 12 weeks, there is statistical significant reduction (p value 0.04) in mean HbAIc values in NV group of 0.58±0.16 whereas in VN group is 0.54±0.16. At 24 weeks, NV group reduction in mean HbA1c is 0.29±0.08 and in VN group reduction is 0.27±0.16 (p value 0.05) when calculated from end of 12 weeks. Reduction in mean PPBS levels, NV group is 44.6±9.4 and VN group is 39.4±9.03 (p value 0.13). At 24 weeks, NV group is 24.18±9.5 and for VN group it is 18±5.6 (p value 0.04). 6 patients taking nateglinide and 5 patients on voglibose complained of hypoglycemic attacks and abdominal fullness respectively. Conclusion: It is observed that nateglinide and voglibose have same efficacy but voglibose has better safety profile.

Keywords: Diabetes mellitus, nateglinide, voglibose


  ENDO – 16: Effect of Ethyl Acetate Extract of Melothria Perpusilla on Dexamethasone Induced Hyperglycemia in Albino Rats Top


Singh Shailendra Vikram Jitendra, Usham Dharmaraja Meetei, Ng. Gunindro Singh, Subhalakshmi Devi A, Rita S

Department of Pharmacology, RIMS

Background: Diabetes mellitus is a spectrum of conditions that includes hyperglycemia. Issues of safety and tolerability limit the optimal use of anti diabetic drugs such as sulfonylureas. Objectives: To evaluate the effect of ethyl acetate extract of Melothria perpusilla (EAMP) on dexamethasone induced hyperglycemia in albino rats. Materials and Methods: Healthy albino rats were divided into 4 groups (control, standard, test I and test II) of 6 animals each. Fasting blood glucose levels were measured. Hyperglycemia was induced by dexamethasone (2mg/100gm i.p.) Then the animals in control group were fed with 2% gum acacia in distilled water, standard group was fed with glibenclamide 0.5mg/kg, test I with 250mg/kg of EAMP and test II with 500mg/kg of EAMP. Standard and test drugs were suspended with 2% gum acacia in distilled water. Blood glucose levels were measured at 1h and 2h. Results: Analysis was done by ANOVA followed by Dunnett's t test. The ethyl acetate extract of Melothria perpusilla produced a significant fall in the blood glucose level on dexamethasone induced hyperglycaemia compared to control. Conclusions: Treatment with Melothria perpusilla improves hyperglycaemia probably by inhibiting gluconeogenesis.

Keywords: Dexamethasone, diabetes mellitus, glibenclamide, Melothria perpusilla


  ENDO – 17: Evaluation of the Anti-Diabetic Effect of Aqueous Extract of Centella Asiatica Leaves on Alloxan Induced Diabetic Male Albino Rats. Top


Laskar IJ, Chakravarty P

Department of Pharmacology, Silchar Medical College and Hospital, Silchar, Assam, India

Introduction: Diabetes Mellitus, remains a major crippling global health issue today .There has been an increasing demand for herbal preparations for its control , as well as provide provisions for safer and cost effective therapies. Centella asiatica (C. asiatica) leaves have been found to have anti-diabetic effects in diabetic rat models . Our study aims at further establishing the anti-diabetic property of C. asiatica. Objectives: To evaluate the anti-diabetic effect of aqueous extract of Centella asiatica in alloxan induced diabetic male albino rats. METHODS: Aqueous extract of Centella asiatica was freshly prepared. The male albino rats were randomly divided into 5 (A,B,C,D,E) groups, each receiving intraperitoneal injection of freshly prepared alloxan monohydrate. Group (A,B,C) were treated with the test sample (C. asiatica) in three different doses (50, 100 and 200mg/kg) respectively. Glibenclamide was taken as the standard hypoglycemic drug for group D. A control group E was maintained. Estimation of blood glucose level was done for fasting as well as following treatment with test sample/standard. Results were expressed as the mean ± Standard Deviation and data analysis was done using ANOVA and paired/unpaired t-test. A confidence level of <0.05 was considered significant. Results: Aqueous extract of C. asiatica reduced blood glucose levels in all groups, with most significant reduction seen at the dose of 200 mg/kg. Conclusion: The study indicates that the Centella asiatica leaves possess significant anti-diabetic activity.

Keywords: Alloxan monohydrate, anti-diabetic, centella asiatica, diabetes mellitus, glibenclamide


  CVS (CARDIOVASCULAR PHARMACOLOGY) Top



  CVS – 1: Alternate Day Atorvastatin Therapy in Dyslipidemia Top


Allen Joe Rodrigues, Laxminarayana Kamath, Ravindra

Department of Pharmacology, Bangalore Medical College and Research Institute, Bengaluru, Karnataka, India

Background: Compared to other statins, atorvastatin has a relatively long half-life, which may allow the administration of this medication on an alternate day basis. Objective: To compare the efficacy of atorvastatin daily versus alternate day basis for the treatment of dyslipidemia. Materials and Methods: In the present prospective study, 42 patients with dyslipidemia according to National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) guidelines requiring pharmacotherapy were randomised into 2 groups. Group A received 10 mg of atorvastatin daily & group B received 10 mg of atorvastatin on alternate day for six weeks. Efficacy was assessed by percentage reduction of low-density lipoprotein cholesterol (LDL-C), total cholesterol(TC), triglycerides (TG) and improvement in high density lipoproteins (HDL-C) in both the groups. Results: LDL-C decreased by 18.96% versus 18.65% (CI 0.95, P = 0.47) with daily and alternate day dosing, respectively. Also 17.65% versus 15% (CI 0.95, P= 0.39) improvement was seen with HDL-C. Both dosing regimens provided similar improvements in total cholesterol (23.16% versus 20.65%) and triglycerides (16% versus 18%). There is no statistically significant difference in reduction in lipid parameters between 2 groups. 3 patients reported with myalgia as adverse effect in daily therapy but non in alternate day therapy. Conclusions: Alternate day atorvastatin is as effective as daily atorvastatin therapy in dyslipidemia. So this study strongly recommends alternate day atorvastatin therapy because of its cost effectiveness, efficacy, safety and compliance.

Keywords: Alternate day atorvastatin, dyslipidemia, low-density lipoprotein cholesterol


  CVS – 2: A Comparative Study of Hypolipidemic Effect of Rice Bran oil and Olive oil in Experimental Animals Top


Ojah K, Gogoi G, Chaliha M, Gohain S

Department of Pharmacology, Jorhat Medical College and Hospital, Jorhat, Assam, India

E-mail: [email protected]

Objectives: The present study aims to compare the hypolipidemic effect of rice bran oil and olive oil in experimentally induced hyperlipidemia on rats. The hypolipidemic effect of rice bran oil and olive oil will be compared with a standard hypolipidemic drug i,e, Atorvastatin. Materials and Methods: The study was conducted in the Department of Pharmacology, Jorhat Medical College, Assam after due permission from Institutional Animal Ethics Committee (IAEC). The animals were divided into 5(five) groups consisting of 6(six) animals each. Group A = Standard diet(SD) Group B = Atherogenic diet(AD) Group C Atherogenic diet(AD) + Atorvastatin Group D = Atherogenic diet(AD) + Rice bran oil(RBO) Group E = Atherogenic diet(AD) + Olive oil (OO) Hyperlipidemia was induced by 1% exrtrapure cholesterol diet. Hypolipidemic effect was measured by using appropriate biochemical tests and histopathological examinations. Results: Both RBO and OO significantly (P<0.05) decreased the levels of blood cholesterol. The standard drug Atorvastatin also showed similar results. Conclusions: Keeping in view, the wide prevalence of Hyperlipidemia and Coronary heart disease, further study can be done to encourage the use of vegetable oils which are less expensive, less toxic and at the same time efficacious.

Keywords: Rice bran oil, Olive oil, Coronary heart disease, Hyperlipidemia, Atorvastatin


  CVS – 3: Comparison of Anti-Platelet Efficacy of Aspirin Preparations in Diabetic Patients. Top


Patel KN, Daswani BR, Ghongane BB

Department of Pharmacology, B J Government Medical College, Pune, Maharashtra, India

Background: In India, Aspirin is marketed as multiple preparations for antiplatelet use and its drug release pattern is likely to affect efficacy. Objectives: This study compares antiplatelet efficacy of four preparations of aspirin by ADP-induced platelet aggregability and bleeding time (BT); and assesses correlation between steady state plasma concentration (Css) and antiplatelet effect of daily 150mg Aspirin. Methods: This was a randomised, investigator-blinded, parallel-group study in 131 subjects of Type 2 DM on oral anti-diabetics having two or more cardiovascular risk factors. Each subject was randomized to receive Plain aspirin, Ecosprin (enteric coated), Colsprin (effervescent) or Aspisol (soluble), for 15 days. Blood samples were taken at day 0 and day 15, two hours after dosing. Results: Total 121 subjects completed study (Plain 30, Aspisol 31, Colsprin 30 and Ecosprin 30) and the baseline characteristics were similar among all groups. All preparations inhibited platelet aggregation (Reduction from day 0 to day 15: Plain-25.9%, Aspisol-23.9%, Colsprin-23.5%, Ecosprin-26.4%; p=0.89) and increased BT (Rise: Plain-236.4%, Aspisol-236.1%, Colsprin-229%, Ecosprin-256.7%; p=0.87) to a similar extent. Salicylate Css measured at day 15 was significantly higher in Colsprin (23.75mg/L) as compared to Ecosprin (19.73mg/L) and Aspisol (19.27mg/L). Plain aspirin produced salicylate Css of 20.8mg/L.There was no significant correlation between salicylate Css and anti-platelet activity for study population [r= -0.124, p= 0.179] or for individual groups. Conclusions: All preparations produced comparable antiplatelet effect which did not correlate with steady state plasma salicylate concentration at daily dose of 150mg.

Keywords: Antiplatelet efficacy, aspirin, diabetes, serum salicylate


  CVS – 4: Evaluation of the Effect of Losartan + Hydrochlorothiazide Versus Olmesartan + Hydrochlorothiazide on Various Biochemical Parameters in Patients with Stage 1 or Stage 2 Hypertension Top


Renu, Sehgal VK, Gupta AK, Singh Harcharan1

Departments of Pharmacology and 1Medicine, Government Medical College, Patiala, Punjab, India

Objective: Purpose of this study was to evaluate the effect of losartan + Hydrochlorothiazide versus Olmesartan + Hydrochlorothiazide on various biochemical parameters i.e. serum uric acid (SUA), blood urea (BU), serum creatinine, serum sodium and serum potassium in patients with stage I and stage II hypertension. Methods: It was a prospective, open labeled, randomized, parallel group comparative study which was conducted for 6 months .The study was conducted to evaluate the effect on biochemical parameters. The study included 70 patients, 35 in each group. The group I patients received Losartan 50mg + Hydrochlorothiazide 12.5mg OD. The group II patients received Olmesartan 40mg + Hydrochlorothiazide 12.5mg OD. The effect on biochemical parameters was seen at baseline, 3 and 6 months. All the observations thus made were statistically analysed using appropriate tests. Results: In group I the mean fall in SUA levels at 6 month was10.72% and in group II there was a rise of 9.66% .In group I the mean fall in BU at 6 month was 4.05% whereas in group II there was a rise of 4.72%. In group I the mean fall in serum creatinine levels at 6 month was 1.83% whereas in group II there was a rise of 1.54%. In group I and group II the mean fall in serum sodium levels at 6 month was 4.82% and 5.16% respectively. In both groups the mean rise in serum potassium levels from baseline value to 6 month were 4.66% and 2.44% respectively. Conclusions: There was a statistically highly significant decrease in SUA in group I whereas in group II a significant increase was observed .The change in BU levels in both groups was not significant. No statistically significant change was observed in serum creatinine in both groups. In group I there was a statistically significant decrease in serum sodium levels in both groups. There was a statistically significant increase in serum potassium levels in both groups.

Keywords: Biochemical parameters, hydrochlorothiazide, hypertension, losartan, olmesartan


  CVS – 5: Study of Effect of Atorvastatin on Serum Level of Lipase and Amylase in Patients of Hypercholesterolemia. Top


Vipul M Navadiya, Anita Sinha, Asif Barejia, Jayant Rai, Mahesh Solu1, Kantharia ND

Departments of Pharmacology and 1Medicine, Government Medical College, Surat, Gujarat, India

Objectives: Several cases of pancreatitis have been reported in patients taking statins e.g. atorvastatin, rosuvastatin and simvastatin. Occurrence of pancreatitis with multiple statins suggests possible association between statin intake and some kind of damage to pancreas. However, most of these data are in form of case reports only. So this study was done to evaluate changes in serum level of lipase and amylase, the reliable markers of pancreatitis, in patients who are newly started with atorvastatin, most commonly prescribed statin in our setup. Materials and Methods: 60 newly diagnosed patients of hypercholesterolemia from New Civil Hospital, Surat were enrolled in the study. Patients with pathological conditions which are already known to affect serum lipase and amylase were excluded from the study. The baseline serum level of lipase and amylase were measured at the onset of atorvastatin therapy. Patients were prescribed tablet atorvastatin 20 mg once a day for 90 days and serum level of both the enzymes were again measured after 90 days. Statistical analysis was done using paired samples t-test. Results: Serum lipase level was found to be significantly increased after 90 days (M=35.2, SD=10.1) as compared to baseline (M=32.2, SD=10.3) with p=0.016. Serum amylase was also significantly increased 90 days later (M=59.40, SD=15.28) as compared to baseline (M=55.92, SD=17.54) with p=0.038. Conclusions: 90 days treatment with tablet atorvastatin 20 mg once a day causes increase in serum level of lipase and amylase. This may be due to some kind of unfavorable effect on pancreas. Further studies are required to evaluate effects of other statins as well as to understand possible mechanism behind this.

Keywords: Amylase, atorvastatin, lipase, pancreatitis, statins


  CVS – 6: Exploration of Cardioprotective and Antioxidant Action of Bilirubin in Isoprenaline Induced Ischemia Model of Male Wistar Albino Rats. Top


Asif Barejia, Acharya CR, Ankit Vataliya, Vipul M Navadiya, Jayant Rai, ND Kantharia

Department of Pharmacology, Government Medical College, Surat, Gujarat, India

Objectives: Ischemic heart disease (IHD) is one of the leading cause of death worldwide. Bilirubin, an endogenous product of heme catabolism, has remarkable antioxidant properties. This study was planned with an aim to evaluate cardiprotective potential of bilirubin in isoprenaline (ISO) induced rat ischemia model. Materials and Methods: In this study a total of twenty-four adult male wistar albino rats (200-250 gm) were divided into 4 groups of 6 rats each. Group I, III and IV respectively received distilled water (10 ml/kg bw), bilirubin (40 mg/kg bw) and bilirubin (60 mg/kg bw) intraperitoneally (i.p.) for 21 days. Along with that group III & IV received ISO (85 mg/kg bw) subcutaneously (s.c.) on 20th and 21st day. Group II received ISO (85 mg/kg bw i.p.) on 20th and 21st day. After 24 hours of ISO administration, rats were sacrificed and biochemical & histopathological parameters were assessed. These parameters were evaluated: Cardiac biomarkers – Lactate dehydrogenase (LDH) and creatine kinase (CK-MB); Antioxidant – Glutathione reductase (GR). Isolated heart specimens were processed for light microscopy. Results: Administration of bilirubin in group III & IV significantly prevented ISO induced elevation of CK-MB and LDH levels as compared to group II. Also there is a significant increase in the levels of GR in group III & IV compared to group II. These changes were significantly higher in group IV (high dose) compared to group III (low dose). Light microscopic findings of the myocardium in bilirubin treated group revealed a well preserved normal morphology of cardiac muscle with minimal evidence of myocardial injury as compared to ISO-treated hearts. Conclusions: Pre-administration with bilirubin is protective against ISO induced myocardial infarction. This beneficial effect is most likely due to its antioxidant property. This study may trigger interest towards the use of bilirubin as a cardioprotective agent in myocardial infarction.

Keywords: Antioxidants, bilirubin, myocardial infarction


  CVS – 7: Combination Therapy of Nebivolol/Amlodipine Versus Metoprolol/Amlodipine Among Indian Hypertensives Top


Divyashree RN, Jayanthi CR1, Raveendra KR2

Departments of 1Pharmacology and 2Medicine, Bangalore Medical College and Research Institute, Bengaluru, Karnataka, India

Introduction: Hypertension, presents as tip of iceberg of a multidimensional problem with more than 50% of patients requiring combination therapy for its management. Combining 2 complementary agents improves response rates to 75-95% and one such combination is calcium channel blocker with beta blocker. Aim: To evaluate efficacy and safety of Nebivolol/Amlodipine (NEB/AM) versus Metoprolol/Amlodipine (MET/AM) among subjects with stage I-II hypertension. Materials and Methods: 40 hypertensives who have not achieved target BP (<140/90mmHg) with amlodipine 5mg/day for four weeks were randomized into two groups of 20 each to receive either Nebivolol 5 mg/day or Metoprolol 50 mg/day OD in the morning as add on for 8 weeks. Efficacy was measured in terms of reduction in SBP & DBP. Safety was assessed by monitoring treatment emergent adverse effects. Results: NEB/AM reduced mean SBP from baseline 158.3±5.95mmHg to 138.3±6.23mmHg at 8 weeks (-20.05, p<0.01) and mean DBP from baseline 99±4.47mmHg to 82.6±4.0mmHg at 8 weeks (-17.3,p=0.02).In MET/AM mean SBP reduced from baseline 160.1±5.78 mmHg to 138.7±10.38mmHg (-21.4,p<0.01) at 8 weeks and mean DBP at baseline 99±5.92mmHg reduced to 85.7±3.13mmHg (-13.3,p=0.02) at 8 weeks. In NEB/AM, there was a significant reduction in mean difference of DBP at 2, (-10.9mmHg vs -6.2mmHg, p = 0.008), 4 (-13.5 vs -10.1mmHg p=0.04) and 8 weeks (-17.3 vs-13.3mmHg p=0.02) from baseline when compared to MET/AM group. No significant adverse effects noted. Conclusions: Nebivolol/Amlodipine combination significantly reduced DBP as compared to Metoprolol/Amlodipine in patients with stage I-II hypertension with no significant adverse effects.

Keywords: Amlodipine, combination therapy, hypertension, metoprolol, nebivolol


  CVS – 8: Cognitive and Glycemic Changes with Statins: A Prospective Observational Study Top


Shantanu Kamboj, Dinesh K Badyal, Rajneesh K Calton1

Departments of Pharmacology and 1Cardiology, Christian Medical College, Ludhiana, Punjab, India

Objective: To detect the changes in cognition and glycemic status in subjects who are newly started on statin therapy. Methods: 50 subjects who were started on atorvastatin, dose ranging from 10-40 mg per day were enrolled. Changes in cognition were assessed using Mini-Mental State examination (MMSE) and glycemic changes were assessed by measuring random blood sugar (RBS) and HbA1c, done at baseline and 3 months. t test & Kendall's W test were used to analyse the data. Results: MMSE score changed from 26.52 ±0.677 at baseline to 25.92 ±3.811 at 3 months which was not statistically significant (p=0.278). The trend test was not significant for changes in MMSE score from baseline (Kendall's W=0.015, χ2=0.727, df=1, p=0.394). HbA1c changed from 5.69 ±0.58 at baseline to 5.75 ±0.44 at 3 months (p=0.461). The trend test was not significant for changes in HbA1c from baseline (Kendall's W=0.026, χ2=1.280, df=1, p=0.258). RBS changed from 114.46 ±16.543 at baseline to 110.66 ±14.282 at 3 months which was not significant (p=0.155). Conclusion: No significant change was found in cognition and glycemic status at 3 months in subjects who are newly started on statin therapy.

Keywords: Cognition, glycemic status, Mini-Mental State Examination, statins


  CVS – 9: To compare Efficacy and Safety of Ramipril as monotherapy versus Ramipril with Torsemide as Combination Therapy in Stage I & Stage II Hypertensive Patients Top


Navjot Kaur, Jasleen Kaur Narula1, Ravinder Garg1, Kamalpreet Palta1

Department of Pharmacology, GGS Medical College (BFUHS), Faridkot, Punjab, India

Objectives: To asses and compare the anti-hypertensive efficacy as well as incidence of adverse drug reactions between monotherapy of Ramipril and combination therapy of Ramipril with Torsemide in Stage I & Stage II hypertensive patients. Materials and Methods: This was a prospective, open labeled, randomized, comparative study, including 100 patients suffering from essential hypertension. Patients were randomly divided in two groups' viz. Group I (Ramipril, 5mg/day) and Group II (Ramipril 5 mg with Torsemide 5 mg/day). Newly diagnosed cases of hypertension were enrolled from medicine department in GGS Medical College, Faridkot and study drugs prescribed for a period of 12 weeks. Blood pressure was measured in sitting position in patients at baseline, 4th week, 8th week and 12th week. Results: In group A (Ramipril) 44 patients achieved goal BP out of 50 patients. The overall SBP/DBP reduction in group A was 23.2±0.89/13.16±0.29 mmHg. Similarly in group B (Ramipril and Torsemide) 48 patients had achieved goal BP within 4 weeks as compared to group A patients. In group B, SBP/DBP reduction was 32.32±0.46/79.08±18.06 mmHg which was more compared to Ramipril therapy. In both the groups Blood urea, Serum Creatinine, Serum electrolytes were not significantly altered. A total of 17% of patients reported mild adverse effects like dry cough (2%), nausea (1%), headache (8%) and increased urination ( 4%), asthenia (1%). Conclusions: In present study it was observed that combination therapy of Ramipril with Torsemide is more efficacious in lowering Systolic blood pressure, Diastolic blood pressure in Stage I & Stage II hypertensive patients to achieve goal BP as compared to monotherapy with Ramipril. Adverse effects were mild and tolerated by both the study groups.


  CVS – 10: Protective Effects of Combination of Quercetin And Baicalein on Myocardial Infarction in Isoproterenol Induced Myocardial Infarcted Rats: Biochemical, Molecular and Histopathological Evidences Top


Mukesh Kumar1,2, Mangala Lahkar1,3, Vikas Kumar2

1Department of Pharmacology and Toxicology, National Institute of Pharmaceutical Education and Research, 3Department of Pharmacology, Gauhati Medical College, Guwahati, Assam, 2Department of Pharmaceutics, Neuropharmacology Research Laboratory, Indian Institute of Technology (Banaras Hindu University), Varanasi, Uttar Pradesh, India

Objective: The aim of the present study was to evaluate the combined protective effects of quercetin and baicalein on isoproterenol induced myocardial infarcted rats. Methods: Male albino Wistar rats were pretreated with a combination of quercetin (50 mg/kg) and baicalein (50 mg/kg) daily for 14 days. After the pretreatment, rats were injected isoproterenol (100 mg/kg) subcutaneously to induce myocardial infarction. Results: Isoproterenol administered rats showed increased levels of serum troponin and Creatine Kinase-MB and histopathological findings revealed marked inflammation and necrotic damage of cardiac tissue. The levels of antioxidant system were significantly decreased while tissue lipid peroxidation and inflammatory cytokines were significantly increased in isoproterenol control rats. In addition, on western blot analysis, the level of NF-кB was significantly increased in Isoprotereno control rats. However, pretreatment with quercetin and baicalein alone and in combination normalized the levels of serum troponin and creatine Kinase-MB. The effect of quercetin and baicalein combination was more significant in normalizing inflammatory cytokines, NF-кB levels and histopathological alterations as compared to single pretreatment. Conclusion: Overall our findings evidenced the cardio-protective effects of quercetin and baicalein via attenuated oxidative stress, inflammation and necrotic damage. Our study also showed that combined pretreatment of quercetin and baicalein was highly effective than single pretreatment.

Keywords: Inflammation and necrosis, myocardial infarction, oxidative stress


  CVS – 11: Involvement of TRPV1 ion Channels in Remote Hind Limb Preconditioning-Induced Cardioprotection in Rats Top


PuneetKaurRandhawa, Amteshwar Singh Jaggi

Department of Pharmaceutical Sciences and Drug Research, Punjabi University, Patiala, Punjab, India

Background:Remote hind limb preconditioning is anon-invasive treatment approach whereby alternate cycles of preconditioning ischemia and reperfusion to the hind limb afford cardioprotection against sustained ischemia-reperfusion injury. Aim and Objective:The current study was designed to investigate the possible involvement of TRPV1ion channels in mediating remote hind limb preconditioning-induced cardioprotection. Material and Materials and Methods: In the present study, forty two animals were divided into seven groups: control, sham, remote hind limb preconditioning, capsaicin5mg/kg and 10 mg/kg, capsazepine 2.5 mg/kg and 5 mg/kg. Four alternate cycles of inflation and deflation (5 min each) of the blood pressure cuff served as the remote hind limb preconditioning stimulus.UsingLangendorff's system, the heart was perfused with physiological solution and subjected to 30 minute ischemia-120 minute reperfusion. Results: Remote hind limb and capsaicin preconditioning significantlyreduced infarct size, LDH release, CK release andimproved hemodynamic parameters including left ventricular developed pressure, +dP/dt and-dP/dt.Prior administration of capsazepine significantly attenuated remote hind limb preconditioning-induced cardioprotection. Conclusions:Remote hind preconditioning stimulus possibly elicits cardioprotective effects via opening of mechanosensitive TRPV1 ion channels.

Keywords: Cardiovascular, remote preconditioning, TRPV1 ion channels


  CVS – 12: Comparitive Assessment of Effects of Calcium Channel Antagonists- Amlodipine And cilnidipine , on QT Interval in Hypertensive Patients- an Observational Study Top


Vartika Srivastava, Sougata Sarkar

Kalinga Institute of Medical Sciences, Bhubaneswar, Odisha, India

Context: The duration of the QT interval as measured by 12-lead electrocardiography is a measure of myocardial repolarization and is widely used to describe cardiac abnormalities, to determine the presence of cardiac toxicity and to evaluate drug safety. In hypertension, the QT interval is a predictor of the risk of both coronary events and cardiovascular death, after adjusting for the effects of additional risk factors. According to AHA and JNC VIII calcium channel blockers are first line drug in treatment of hypertension. The equipotent antihypertensive effect of Cilnidipine and Amlodipine in their eqivalent dose has been demonstrated in number of studies. Aims: To compare and evaluate the effects of calcium channel antagonists Amlodipine and Cilnidipine on QT interval amongst hypertensive patients. Settings and Design: This is a comparative, non blinded, single centred, prospective and parallel groups, observational study , conducted in medicine OPD clinic of KIMS over a period of 24 months. The study was approved by the Institutional Ethical Committee, KIMS, BBSR Materials and Methods: Total 258 patients were screened and examined, amongst them 48 patients were selected and enrolled as study participants during that period. The enrolled patients were then divided as (1) Hypertensive patient (n=159) - selected patients received either Amlodipine (2.5 to 10mg) or cilnidipine (5 to 20 mg) with or without ARB. (2) Hypertensive with controlled diabetic patients (n=99) - selected patients received either Amlodipine (2.5 to 10mg) or cilnidipine (5 to 20 mg) with or without ARB alongwith antidiabetic medication. Calculated by Bazett's formula (most commonly used) = QT Interval / √ (RR interval) where RR Interval = 60/HR. Normal QTc ≤ 440 msec. Statistical Analysis used: All values were expressed as mean ± SD . Statics applied is unpaired t test and paired t test. Predetermined clinically relevant margin is change in 10 msec of QTc . Significance is set at P ≤ 0.05. Results: There was extremely significant QTc reduction was seen with Cilnidipine therapy and significant elevation seen by Amlodipine treatment but without any clinical relevance. While comparing the effect of Amlodipine and Cilnidipine, extremely significant as well as clinically relevant difference between the two treatment was noted. Conclusions: From this study it can be concluded that Cilnidipine reduces QTc interval and hence is a better choice over Amlodipine for patients suffering from long QT interval.

Keywords: Amlodipine, cilnidipine, hypertension, QT interval

[TAG:2]CVS – 13: Understanding Regulation of Autophagy in Cardiac Hypertrophy: an Insight into use of Autophagy - Targeted Drugs [/TAG:2]

Vandana Sankar

Agroprocessing and Technology Division, CSIR-National Institute for Interdisciplinary Science and Technology, Trivandrum, Kerala, India

Objectives: Autophagy is a cellular homeostatic process involving lysosome-dependent turnover of organelles and proteins. Alterations of autophagy occur in various cardiac pathologies. In response to hypertension, the heart initially compensates with an adaptive hypertrophic increase in cardiac mass. But under prolonged stress, the hypertrophied heart undergoes irreversible change resulting in diminished performance. Since hypertrophy is a major predictor of heart failure, its prevention is an important therapeutic target. An approach towards modulating hypertrophy at the cellular level by targeting autophagy will be a promising avenue for addressing the problem of hypertrophy and failure. Methods: The experimental model used was H9c2 cardiomyoblasts. Hypertrophy was induced using isoproterenol (ISO) and assessed by flow cytometry- based forward scatter data. Autophagy was detected using monodansylcadaverine and LC3B by confocal microscopy and flow cytometry. Rapamycin and chloroquine were used as activator and inhibitor of autophagy respectively. Results: ISO stimulation resulted in an increase (27%) in hypertrophied cells compared to control. Increased autophagy (15%) could be associated with augmentation of hypertrophy as hypertrophy was found to increase significantly (p≤0.05) with rapamycin post treatment in ISO-stimulated cells. Chloroquine reduced autophagy and also reduced (52%) the percentage of hypertrophied cells. Thus it is inferred that by inhibiting autophagy, it is possible to attenuate hypertrophy, even though further investigations have to be done to establish the findings. Natural compounds will be tested for their efficacy to inhibit autophagy Conclusions: Efforts to target autophagy selectively in the cardiomyocyte may be a rational step toward the development of novel strategies to prevent hypertrophy and failure in humans.

Keywords: Autophagy, cardiac hypertrophy, chloroquine, isoproterenol, rapamycin


  CVS –14: Demonstration of Resolution of Amlodipine Induced Pedal Edema by Cilnidipine Top


Kiran Shetty1, Ranjan Shetty1,2, Deepak1, Bairy KL3, Pragna Rao4

Deprtments of Cardiology, 3Pharmacology and 4Biochemistry KMC, Manipal University, Manipal, 2Deprtment of Cardiology, Manipal Hospital, Bengaluru, Karnataka, India

Objectives: To study the clinical and biochemical parameters between amlodipine induced pedal edema (AIPE) and amlodipine treated non-pedal edema (ATNE) groups and demonstrate the resolution of AIPE by substitution of cilnidipine. Materials and Methods: This was a prospective, Interventional study. Conducted at the tertiary care center in south India. A total number of 66 (n = 66) patients with essential hypertension with the AIPE of both genders, attending the outpatient department of medicine and cardiology, were included in the study. AIPE was confirmed by various tests. After the Initial screening, amlodipine therapy was substituted to cilnidipine with an efficacy equivalent dose. Clinical and biochemical parameters measured at the onset of the study and reassessed after 4 weeks of cilnidipine therapy. Results: AIPE group showed higher BP than the ATNE group (p<0.001). AIPE completely resolved in all the patients. AIPE group showed higher VMA level than the ATNE group, which is statistically significant (p<0.001), which is end metabolite of catecholamine. There was a substantial reduction in body weight and BMI (P <0.001). Serum proteins, creatinine, sodium did not show any significant difference between the two groups. Conclusion: Cilnidipine therapy lead to a complete resolution of AIPE, along with a better hypertension control. Cilnidipine is decreasing the release of catecholamine by inhibiting N-type of calcium channels at the neuronal terminal. Cilnidipine is a suitable alternative antihypertensive medication for patients with the amlodipine-induced edema.

Keywords: Amlodipine, cilnidipine, pedal edema, vanillyl mandelic acid


  CVS – 15: Naringenin Ameliorate Isoproterenol-Induced Myocardial Infarction Through Down-Regulation of Protease Activated Receptors Top


Yogesh Bulani, Anas Ahmed, Sharma SS

Department of Pharmacology and Toxicology, National Institute of Pharmaceutical Education and Research, S.A.S Nagar, Punjab, India

Objectives: Despite understanding several mechanisms of myocardial infarction (MI) associated cardiac injury, management of this clinical condition remains obscure. In MI, degradation of endothelial layer leads to exposure of membrane to circulating protease such as thrombin, trypsin etc. Thrombin acts through protease activated receptors (PAR), this study investigate the role of PAR (predominantly thrombin receptor PAR1 and PAR4) in cardiac injury associated with myocardial infarction and whether PAR signaling can be modulated by pretreatment with antioxidants or not? β- Adrenergic overstimulation using high dose of isoproterenol (ISO) is widely used animal model to study myocardial infarction associated cardiac injury in which oxidative stress play an important role. Antioxidants therefore have been very widely studied therapeutic interventions in the animal models of isoproterenol-induced myocardial infarction. Methods: In the present study we evaluated the effect of pretreatment of naringenin at the dose of 30 and 100 mg/kg in ISO model of MI in rats. We assessed the structural, functional (blood pressure and left ventricular function), biochemical parameters (plasma and tissue markers) and change in PAR expression. Results: Isoproterenol (ISO) increased the production of reactive oxygen species, leading to severe oxidative stress and structural and functional deficits in the myocardial tissue along with increased expression of PAR1 and PAR4. Increased PAR1 and PAR4 level represents endothelial damage in ISO induced myocardial infarction. Naringenin pre-treatment demonstrated remarkable beneficial effects on cardiac structural changes. Naringenin pretreatment also significantly attenuated the altered levels of myocardial injury biomarkers along with normalization of left ventricular expression level of PAR1 and PAR4. Conclusion: This study implicates the role of PAR in isoproterenol-induced MI and reduction of PAR expression by naringenin.

Keywords: Isoproterenol, myocardial infarction, naringenin, protease activated receptors


  RSP (RESPIRATORY SYSTEM PHARMACOLOGY) Top



 Escherichia More Details coli and Pseudomonas aeruginosa in A Tertiary Care Hospital">  RSP – 1: Incidence And Resistance Pattern of Klebsiella pneumoniae ,Escherichia coli and Pseudomonas aeruginosa in A Tertiary Care Hospital Top


Khare Anubhuti, Kothari Saroj,Gandhi Shashi1

Departments of Pharmacology and 1Microbiology, G.R. Medical College, Gwalior, Madhya Pradesh, India

Objective: To determine the incidence & resistance pattern of Klebsiella pneumoniae Scientific Name Search  (K.pneumoniae),  Escherichia coli Scientific Name Search  &  Pseudomonas aeruginosa Scientific Name Search .aeruginosa), to prepare their local antibiogram & discuss the general issues related to antimicrobial resistance. Materials and Methods: Prospective study was carried out between March to October 2015. Samples of urine, blood, pus, CSF & miscellaneous samples (fluids, swabs, sputum & stool) were collected from indoor & outdoor patients for isolation & antimicrobial susceptibility of E.coli, P.aeruginosa & K.pneumoniae in the Department of Microbiology G.R. Medical College, Gwalior (MP). Results: Out of the 5000 samples analyzed 1684 showed growth. K.pneumoniae, E.coli & P.aeruginosa were 38.50%, 33.29% & 28.19% resp. from a total of 805 isolates of these bacteria. Both E.coli & K.pneumoniae showed highest sensitivity for doxycycline (75% ; 67% resp.) & second highest for levofloxacin (70% ; 64% resp.), whereas, P.aeruginosa showed highest 57% sensitivity for amikacin followed by 48% for levofloxacin. β-lactam antibiotics & aminoglycosides showed high mean resistance (K.pneumoniae-83%, E.coli-79%, P.aeruginosa-86.4%) & (K.pneumoniae-75%, E.coli-61%, P.aeruginosa-70%) resp. Conclusion: The data indicates high resistance among the gram-negative bacteria for β-lactam & aminoglycoside antibiotics. Increasing resistance to doxycycline & flouroquinolones for K.pneumoniae & E.coli and multidrug resistance to P.aeruginosa is a cause of concern in this region. Thus, there is a need to stop misuse of antibiotics with immediate effect & to implement a strong antimicrobial stewardship program.

Keywords: Antimicrobial sensitivity, gram-negative bacteria, resistance, stewardship


  RSP – 2: Response to inhaled corticosteroids on serum CD28, quality of life and peak expiratory flow rate in bronchial asthma Top


Anubhuti Gupta

Department of Pharmacology, Lady Hardinge Medical College, New Delhi, India

Background: CD28 is a 44 kDa glycoprotein which is important in initiating T cell responses and results in an increased T-cell proliferation and IL-2 production. This study estimated the serum CD28 levels in asthmatic patients and evaluated the effect of inhaled corticosteroids (ICS) on the levels of CD28 and peak expiratory flow rate (PEFR) and quality of life (QOL). Methods: This prospective open label observational study enrolled 40 adult asthmatic patients of mild to moderate severity who were started on ICS and 40 healthy controls. Bronchial asthma patients were evaluated for their serum CD28, QOL using MiniAQLQscores, severity of symptoms and PEFR at baseline and after 4 weeks. Results: Serum CD28 concentration in asthmatic patients was 107 ± 4.98 ng/ml which was significantly elevated (p<0.01) as compared to healthy individuals (37.67 ± 18.28 ng/ml). ICS treatment for 4 weeks reduced serum CD28 levels to 40.9 ± 2.82 ng/ml. PEFR increased significantly from 190.75 ± 10.55 L/min to 263 ± 10.69 L/min (p<0.01) after 4 weeks. Similarly, MiniAQLQ scores significantly increased from 36.90 ± 10.31 at day 0 to 70.63 ± 11.56 on day 28 after ICS therapy (p<0.01). A negative correlation between the elevations of serum CD28 is seen with QOL. Conclusion: Serum CD28, a marker of inflammation, is raised in allergic asthma and is reduced by ICS therapy. ICS also improved QOL scores and objective clinical outcomes in asthma patients. The study has been registered with Clinical Trials Registry-India. Registry database number CTRI/2015/07/005977.


  CP (CLINICAL PHARMACOLOGY) Top



  CP – 1: A Prospective Observational Study to Compare Efficacy and Safety of Bupivacaine Plus Dexamethasone Versus Bupivacaine Plus Fentanyl for Caudal Block in Children Top


Ashwini Patil, Radha Yegnanarayan, Jyoti Kale

Departments of Pharmacology and Anaesthesia, SKNMC and GH, Pune, Maharashtra, India

Objectives: To compare dexamethasone versus fentanyl as an adjuvant to bupivacaine for caudal block in children in relation to the duration of caudal analgesia, post-operative analgesic requirement & incidence of post-operative nausea & vomiting. (PONV). Methods: This prospective observational study was conducted after obtaining Institutional Ethics Committee approval & informed consent from parents of participants. 60 children, aged 1–6 years, undergoing lower abdominal surgery were randomized to receive either a mixture of dexamethasone 0.2 mg/kg added to 1 ml/kg bupivacaine 0.25% (group A) or mixture of fentanyl (1 ug/kg) added to 1ml/kg Bupivacaine 0.25% (group B). Post-operative pain was assessed using Modified Objective Pain Scale (MOPS) score until 12 h after surgery and rescue analgesic was administered at MOPS score 4 or more. The number of analgesic doses required in first 24 h after surgery, residual motor block, sedation scores, intra and post-operative hemodynamic variables (PONV), and other adverse effects were recorded. Results: Group A showed significantly longer time to first analgesic requirement than group B (p<0.001). Number of rescue analgesic doses required in the first 24 h was significantly less in group A(p<0.001) and showed significantly lower MOPS scores than group B(p<0.05). Modified Bromage scale scores, sedation scores, as well as intra and post-operative hemodynamic variables were comparable in two groups. Group A showed significantly fewer episodes of PONV compared with group B. Conclusions: Adding dexamethasone to bupivacaine prolongs the duration of postoperative analgesia and decreases the incidence of PONV as compared to fentanyl after caudal block in pediatric patients.

Keywords: bupivacaine, caudal analgesia, dexamethasone, pediatric patients.


  CP – 2: Drugs Used for Postoperative Analgesia at a Tertiary Care Teaching Hospital: A Prospective Crossectional Study Top


Shreya patel, Praveen Chaudhary, Kamlesh Patel, Supriya Malhotra

Department of Pharmacology, Smt.N.H.L.Municipal Medical College, Ahmedabad, Gujarat, India

Objectives: Inadequate pain relief in the postoperative phase is well known problem world wide. This study was planned with the objective to identify drug use pattern in post operative analgesia with a hope of improving the quality of care protocol Methods: A prospective observational study was carried over a period of one year from OCT 2014 – Sept 2015.Patients in post operative ward ,who underwent operative procedures in departments of obs&gyn,surgery,orthopedics and ENT were included .Data was analysed with respect to drugs used for postoperative analgesia. Results: A total of 199 patients were included in the study .In orthopedic department 54 patients underwent surgeries with majority of the patients( 55%) belonging to 21 to 40 yrs.The most common drug used was diclofenac (72.2%), tramadol ( 38.89% ) and fentanyl(22.2%).In Obg Gynaec department , a total of 45 patients were included with majority belonging to 21-30 yrs (64.4%) age group. The most common drug used for pain relief was tramadol ( 93.3%).A total of 73 patients were included from surgery with the most common age group being greater than 60 yrs . Most common drug used were diclofenac (89%) and tramadol ( 24% ).As far as ENT department was concerned ,the most common drug group was 11 to 20 yrs (40.74%)with diclofenac and tramadol prescribed in 85.18% and 70.3% respectively. Conclusions: The most common drugs used were diclofenac ,tramadol, and fentanyl. Prescription for analgesia can be improved in terms of incorporation of other pain relievers to provide better analgesia.The major limitation of the study was that it did not compare the analgesic effects among patient groups.This can be planned in future.

Keywords: Analgesic, diclofenac, postoperative patients, tramadol


  CP – 3: Effect of Ranolazine Versus Trimetazidine on Left Ventricular Dysfunction in Patients with Chronic Stable Angina-A Randomized Controlled Clinical Trial Top


Melvin G, Madhu Prabhu Doss, Varsha S, Amrita J, Luxitaa G, Dhandapani VE

Departments of 1Clinical Pharmacology and 2Cardiology, SRM MCH and RC, Chennai, Tamil Nadu, India

Objective: Ranolazine and trimetazidine are metabolic modulators that are extensively used in the treatment of chronic stable angina for pain relief. It is not known if these drugs could reverse the left ventricular dysfunction that is seen in these patients. The study was performed to evaluate the safety and efficacy of ranolazine versus trimetazidine in patients with left ventricular dysfunction associated with chronic stable angina.Material and Methods: We performed a randomized double blind controlled clinical trial in which patients were randomized to receive ranolazine (500mg BD) or trimetazidine (35mg BD) for 8 weeks in a 2:1 ratio using computer generated randomization sequence. Transthoracic echocardiogram (TTE) was performed before and after 8 weeks of drug therapy. Adverse events were recorded during the study. Outcome assessors were blinded to the study interventions. Results: A total of 29 patients [Ranolazine-19; trimetazidine-10] participated in the study after obtaining informed consent. There were no differences in the baseline characteristics between the two study groups. There was a significant difference in the left ventricular ejection fraction (LVEF) between baseline and follow-up in the ranolazine group (p=0.04). There was a greater incidence of palpitation in the trimetazidine group than the ranolazine group (5 versus 0, p=0.01). Neither ranolazine nor trimetazidine was able to produce any improvement in the degree of diastolic dysfunction. Conclusions: Ranolazine when given for a short period of 8 weeks has a modest role in improving systolic dysfunction but has no effect in improving diastolic dysfunction.

Keywords: Diastolic dysfunction, left ventricular dysfunction, ranolazine, trimetazidine


  CP – 4: Drug prescribing pattern in Chronic Kidney Disease Patients at a Tertiary care Teaching Hospital: A cross Sectional Observational Study Top


Sumanth Garimella, Seshayamma V, Sarath Babu, Hari Jagannatha Rao, Siva kumar, Ch.Uday Kumar

Department of Pharmacology and Department of Nephrology, Alluri Sitha Ramaraju Academy of Medical Sciences, Malkapuram, Andhra Pradesh, India

Introduction: Patients with Chronic Kidney Disease usually have multiple co morbidities and therefore require multiple medications. Objective: To evaluate the prescribing pattern in patients of chronic kidney diseases. Results: A total of 150 patients diagnosed with Chronic Kidney Disease were included in the study. Study conducted at Nephrology Intensive Care Unit (ICU), study duration is 3 months. Average age of patient is 56.04(7.55).No drug was found to be prescribed by generic name. Total 1679 drugs were prescribed, given in parenteral, oral and nebulisation route. Most common prescribed drugs were Phosphate binders, Anti microbials, Anti hypertensive's, Proton pump inhibitors, and Iron supplements. Very less number of medications were prescribed out of National List of Essential Medicines (NLEM). About 30% were vaccinated with pneumococcal vaccine. Conclusions: Phosphate binders were found to be most commonly prescribed drugs. Maximum numbers of drugs are prescribed from cardiovascular system and alimentary tract. Duration of Hospital stay increased in patients with comorbities associated with Chronic Kidney Disease than Chronic Kidney Disease (CKD) alone.

Keywords: Chronic kidney disease, phosphate binders, prescribing pattern


  CP – 5: An Intensive Monitoring of Adverse Drug Reaction in Indoor Patients of Internal Medicine Wards at Tertiary Care Teaching Hospital Top


Rajpara Atul, Kanani Neeta

Department of Pharmacology, Government Medical, Baroda, Gujarat, India

Objectives: The study was conducted with aim of intensive monitoring of adverse drug reactions in inpatients of medicine wards of tertiary care teaching hospital and to estimate the incidence and document the spectrum of adverse drug reactions in studied patients in terms of causality, severity and preventability. Materials and Methods: This prospective, observational, single centre study was conducted at internal medicine wards of SSG hospital, Vadodara over a duration of 8 months, after taking prior permission from the regulatory bodies of the institute. The necessary data was obtained and recorded on a pre-designed “Case Record Form” and “IPC-ADR reporting form” after taking written informed consent and analysed with MYSTAT version12. Results: We have screened total 11,400 patients from all 9 wards of medicine department. Amongst them 66 patient developed 88 ADRs with incidence of 0.5789% and total 80 drugs were suspected for this. We classified them in to Group A (38, 57.58%), ADR developed after hospitalisation and Group B (28, 42.42%), ADR is the reason for hospitalisation. Majority of ADRs were in 31-60 age group (44, 66.67%) and more in Males (45, 68.18%). In Group A, the most common onset of ADRs was <1 day (17, 25.76%) while that of in Group B was >30 days (19, 43.94%). Also, the majority of ADRs in Group A were resolved between 1-7 days (29, 43.94%) whereas in Group B it was >7 days (15, 22.73%). The most common category of causality assessment was “Probable” according to both WHO-UMC criteria (53, 54.65%) and Naranjo scale (54, 55.68%). According to Modified Hartwig-Seigel scale maximum ADRs (43, 48.32%) fall in to “Moderate” category and according to Modified Thornton and Schumock criteria the “Preventable” ADRs were (29, 30.85%). Conclusions: The drug safety seems to be well taken into account in our setup with lower incidence rate found in our study, but there is still need of improvement to reduce those preventable ADRs.

Keywords: Drug safety, intensive ADR monitoring, medicine inpatients, pharmacovigilance.


  CP – 6: A Prospective Observational Study of Drug Usage in Snake Bite Patients and Their Outcome in a Tertiary Care Teaching Hospital Top


Supriya KH, Nagabushan H, Prakash GM

Department of Pharmacology. Mandya Institute of Medical Sciences, Mandya, Karnataka, India

Objectives: To assess the pattern of management of snakebite especially with respect to use of anti- snake venom and other supportive treatment given. To assess the effect of anti-snake venom on different types of snakebite and to assess their outcome. Materials and Methods: A prospective observational study was conducted over a period of 6 months, after getting approval from Institutional Ethics committee. Total of 144 snake bite patients were analysed during six months duration for use of anti-snake venom and other supportive treatment in their management and were assessed for their outcome like recovery, morbidity and mortality. Results: Out of 144 snake bite patients analysed 71.5% had poisonous type and 28.4% had non- poisonous type of snake bite. Out of 71.5% of poisonous snake bite 73.7% were of known type, which included 47.3% of viper, 25% cobra, 14.4% of krait, 11.8% of sea snake and 1.3% of green snake. Anti-snake venom (ASV) was given to 62 patients depending on severity of which 22 patients developed reaction to ASV. Patient with reaction to ASV were treated with corticosteroid and antihistamine injection. Morbidity was seen in 29.1% of patients who developed either cellulitis or gangrene of bitten area, which was more commonly seen in viper bite patients (54.7%). Conclusions: Snakebite is one of the commonest tropical diseases leading to envenomation and poisoning especially in rural areas of tropical countries which has to be treated as early as possible to prevent complications. Majority of the cases in our study were of viper bite and most of them have recovered after treatment.

Keywords: Anti-snake venom, morbidity, viper


  CP – 7: Therapeutic Drug Monitoring of Carbamazepine and Phenytoin: Monotherapy versus Combination Therapy Top


Rupali Bandagi, Balasaheb Ghongane, Harti Daswani, Shashikala Sangle1

Departments of Pharmacology and 1Medicine, B.J. Government Medical College and SGH, Pune, Maharashtra, India

Objectives: To study serum concentration of carbamazepine (CBZ) and phenytoin (PHT), when given singly and together. Methods: This is a non-interventional, cross-sectional, analytical study done in a tertiary care hospital. Consenting epileptics on stable antiepileptic regime for at least past 2 weeks and taking CBZ 200mg BD (group I) or PHT 100mg BD (group II) or CBZ(200)+PHT(100)mg BD (group III) were included. There were 10 patients in each group. Blood samples were collected 12 hours after the last dose and serum was analyzed for CBZ, PHT concentrations using HPLC method and data was compared using unpaired t-test. Results: Mean serum CBZ concentration in group I was (8.24±2.66)μgm/ml and in group III (5.99±5.92)μgm/ml (p=0.27). Mean serum PHT in group II was (8.56±4.61)μgm/ml and in group III (10.78±5.24)μgm/ml (p=0.59). When used singly CBZ produced therapeutic concentration in 50% patients while concentration was subtherapeutic in 20% and toxic in 30 % subjects. In combination group 70% patients showed therapeutic and 30% showed subtherapeutic concentrations. Serum PHT given singly or in combination produced therapeutic concentration in 50%, subtherapeutic in 40% and toxic in 10% patients. Yet, no patient showed clinical signs of failure or toxicity despite non-therapeutic concentrations. Conclusions: Co-administration of CBZ and PHT do not affect their serum concentrations. It's possible that Indian population has different therapeutic range of antiepileptic drugs from that given in standard literature. But larger study needs to be done to confirm the results.

Keywords: Carbamazepine, HPLC, phenytoin, therapeutic drug monitoring


  CP – 8: Comparison of Single Versus Multiple Doses of Antibiotic Prophylaxis in Reducing Post-Elective Caesarean Section Infectious Morbidity. Top


Dolly Roy, Supratik Roy Choudhury

Department of Pharmacology, Silchar Medical College and Hospital, Silchar, Assam, India

Objectives: To compare the effectiveness of single dose against multiple doses of antibiotics to reduce postoperative infections in elective caesarean section. Materials and Methods: It is a prospective clinical study conducted in a tertiary care teaching hospital for 3 months (May-July, 2016) under the approval of institutional ethical committee. 120 patients undergoing elective caesarean section are being randomly selected and divided into two groups of 60 each. One group comprises the patients receiving a single prophylactic dose of Ceftriaxone injection and the other group comprises the patients receiving multiple postoperative doses of antibiotics. The patients will be compared on the basis of development of postoperative febrile morbidity, endometritis, urinary tract infection, wound infection and other infections. Statistical analysis will be carried out by using Chi Square test. Results: Till now study has been conducted on 76 patients, each group having 38 patients. There have been no significant differences among the patients in single and multiple dose groups in terms of their age distribution, gravida, period of gestation, body mass index, indications for elective caesarean section or operation proceduress. There has been 7.9% and 5.2% febrile morbidity, 7.9% and 10.5% wound infections, 2.6% and 5.26% urinary tract infection in the single dose and multiple dose groups respectively. But none of the differences are statistically significant. Conclusions: A single prophylactic dose of Ceftriaxone given either before incision or post cord clamping gives as much protection as multiple postoperative doses of antibiotics in preventing postoperative infectious morbidity in elective caesarean section.

Keywords: Antibiotics, caesarean section, ceftriaxone, infections, prophylactic


  CP – 9: Analysis of Fixed Drug Eruptions and Causality Assessment, Presented to a Tertiary Care Teaching Hospital of Odisha Top


Shweta Supriya Pradhan, Abhishek PA, Tarai A, Swain TR, Mohanty S, Sinha M1, Mohanty P1

Depertment of Pharmacology and1 Dermatology, SCBMCH, Cuttack, Odisha, India

Aim and Objectives: To analyse the incidence, nature and presentation pattern of fixed drug eruptions presented to a tertiary care hospital of Odisha. Materials and Methods: A prospective study was conducted by the Dept. of Pharmacology to know the presentation pattern of FDEs in collaboration with Dept. of Dermatology of SCB MCH from 1st august 2015 to 30th July 2016. Diagnosis of FDE was based essentially on clinical findings and confirmed by pathological data. Patient's demographic profile, Onset of FDE and a list of suspected drugs was recorded and analysed. Causality assessment done using WHO-UMC scale. Results: 105 numbers of patients were enrolled in the study out of which 85 patients were analysed after exclusion. Antimicrobial agents particularly fluoroquinolones were commonly associated with FDEs followed by NSAIDs either alone or in combination. The time between drug intake and appearance of FDE was on average 2 hrs. FDE was commonly presented on the lips, oral mucosa, extremities in females where as it was more marked on genitalia & extremities in males. Causality assessment revealed that most FDEs are of “possible” in nature. Conclusions: FDEs are common presentation in the dermatology Dept. following drug use. Antimicrobial and analgesics are more commonly associated with FDEs either alone or in FDCs for causing FDE. The presentations of FDEs can be different in site in both sexes.

Keywords: Causality, drugs, fixed drug eruptions


  CP – 10: SGLT-2 Inhibitors and Risk of Genito-Mycotic Infection: an Observational Study on Indian Population Top


Ayan Mukherjee, Avijit Kundu, Avijit Hazra, Satinath Mukhopadhyay1

Departments of Pharmacology and 1Endocrinology, IPGMER and SSKM Hospital, Kolkata, West Bengal, India

Objectives: To study incidence and characteristics of genito-mycotic infections in diabetes patients receiving SGLT-2 inhibitors as add on to other antidiabetic drugs. Methods: Patients were selected from the Diabetic Out-patient Clinic of a tertiary care public hospital if they were started on SGLT-2 inhibitors (dapagliflozin, canagliflozin, empagliflozin) in addition to existing antidiabetic therapy (oral antidiabetics or insulins). After careful baseline clinical examination, subjects were followed up for 3 months with recommended frequency of clinic visit being once per month. Telephonic follow-up was maintained for patients who did not comply with the visit frequency. Genito-mycotic infection events captured included bacterial infections as well as candidial vulvovaginitis, balanitis and balanoposthitis. OPD was visited twice per week and sampling was purposive. Results: Total of 95 subjects have been recruited till date, of which 70 have completed 3-month follow up. enito-mycotic infection incidence is 19 (20%; 95% confidence interval 11.96- 28.04%) with 10 affected subjects being males. The median age of the affected subjects is 52 years (interquartile range 46 – 63) years. Of these 19 subjects, blood glucose levels are within acceptable limits at last follow-up in 5. The infections include urinary tract infection in 21.05%, vulvovaginitis in 31.58%, balanoprosthitis in 42.1%, phimosis in 5.26%. No infections have been encountered in circumcised subjects. All three SGLT-2 inhibitors are involved. Conclusions: Genito-mycotic infections are common with SGLT-2 inhibitor use and seems to be a class effect. The effect of potential confounders such as age, blood glucose level and circumcision needs further exploration

Keywords: Blood glucose level, genito-mycotic infection, SGLT-2 inhibitor


  CP – 11: Valproic Acid Versus Lamotrigine as First-Line Monotherapy in Newly Diagnosed Idiopathic Generalized Tonic –Clonic Seizures in Adults – a Randomised Controlled Trial Top


Vishal Prakash Giri

Department of Pharmacology, TMMC and RC, Moradabad, Uttar Pradesh, India

Introduction: Idiopathic generalized tonic-clonic seizures (GTCS) are frequently encountered in adults. Their successful control is necessary to improve the quality of life of these patients. Valproic acid is a simple branched-chain carboxylic acid and lamotrigine is a phenyltriazine derivative. Opinions differ in regards to their effectiveness in idiopathic GTCS. Objectives: To compare the effectiveness of valproic acid and lamotrigine in newly diagnosed adults with idiopathic generalized tonic-clonic seizures. Materials and Methods: The present prospective randomized study was conducted on sixty patients suffering from idiopathic GTCS. Thirty patients received valproic acid and rest thirty patients received lamotrigine. All patients were followed regularly monthly for one year for treatment response and adverse effects. Results: After 12 months follow- up, 76.67 % patients taking valproic acid and 56.67 % patients taking lamotrigine were seizure-free. Common adverse effects recorded were nausea, dyspepsia, headache and skin rash. Conclusions: Valproic acid is more effective than lamotrigine as first-line drug in the treatment of adults with newly diagnosed idiopathic generalized tonic-clonic seizures.

Keywords: Lamotrigine, seizures, tonic-clonic, valproic acid


  CP – 12: Comparison of Effects of Benidipine and Amlodipine on Clinical and Biochemical Parameters in Hypertensive Patients: an Observational Study Top


Sharma B, Dange SV

Department of Clinical Pharmacology, DYPMC, Pune, Maharashtra, India

Objectives: Hypertension is a widespread public health problem and a major risk factor for cardiovascular disease. Amlodipine, a calcium channel blocker, dilates arterioles by blocking L-type calcium channels. Benidipine inhibits L, N, and T type calcium channels. We compared the efficacy of Amlodipine and Benidipine on blood pressure, pulse rate, proteinuria and lipid profile in hypertensive patients. Methods: The study was an observational, prospective, open label comparison. Eligible hypertensives were given either amlodipine(5mg/d) or benidipine(4mg/d). Clinical features and laboratory parameters were recorded initially and after 3 months. Adverse events were recorded with the help of a questionnaire. Compliance was assessed by return pill count. Results Out of 35 patients, recruited for study, 16 received Amlodipine and 17 were treated with Benidipine and two were lost during followup. Both the groups were well matched in terms of age, body weight, clinical findings and laboratory values. Both the drugs significantly (P<0.05) reduced systolic (142+/-16 to 138+/-15 vs.148+/-16 to 134+/-14 mmHg) and diastolic blood pressure (97 +/- 5 to 81+/-9 and 95 +/- 6 to 79+/-7). In the Amlodipine group the pulse rate after treatment tended to be higher than before (70+/-9 to 72+/-10 bpm). In the Benidipine group there was decrease in pulse-rate after treatment (69+/-9 to 67+/-9). Unlike Amlodipine, Benidipine significantly (P<0.05) decreased urinary protein excretion (1.0+/-1.2 to 1.1+/- 1.4 vs. 1.4+/- 2.5 to 1.1+/-1.7 g/g-Cr) and serum triglycerides (125+/-25to120+/-23vs130+/-26to115+/-21mg/dl). Conclusions: In this study,Amlodipine & Benidipine were found to be be equally effective anti-hyprtensives in patients with stage 1 hypertension.However,there was significant (P<0.05) reduction in proteinuria and serum triglycerides in Benidipine group as compared to Amlodipine group. Benidipine may be a better alternative to existing calcium channel blockers.

Keywords: Amlodipine, benidipine, hypertension


  CP – 13: Case Report: Magnesium Valproate Induced Pedal Oedema on Chronic Therapy: A Rare ADR Top


Rajan Negi, Dinesh Kansal, Parveen Kumar Sharma, Atal Sood, Himani, Neetu Bala

Department of Pharmacology, Dr RPGMC, Kangra at Tanda, Himachal Pradesh, India

Introduction: Valproate is a drug of choice for treatment of epilepsy, bipolar disorder and for the prophylaxis of migraine headache in adults. Despite the fact that lithium is more efficacious in maintenance of bipolar disorder but its use is abated by its adverse effects. Common adverse drug reactions of valproate are gastrointestinal symptoms, sedation, ataxia, tremor, rash, alopecia, appetite stimulation and rare ones are fulminant hepatitis, pancreatitis, hyper-ammonemia and pedal oedema. Case Report: A 68 Years old female on valproate magnesium (MACORATE ®CR 400) three times a day orally since 2002 for bipolar disorder with no other chronic disease. Patient reported bilateral pedal oedema on 4/04/2016 which was steadily increasing. There was no evidence of CHF, hepatic disease or renal failure clinically. Her LFT and KFT were normal. Patient discontinued the medicine on 10/04/2016 due to non-availability of the drug. Pedal oedema was assessed regularly and was not assessable clinically 26/06/2016. The patient and family decided to withhold drug treatment for bipolar disease. ADR was assessed by WHO UMC scale. Discussion: Prescribing magnesium and not sodium salt of valproate to avoid salt and water retention is not always successful. A delayed onset reversible pedal oedema has also been reported earlier with valproate as a rare ADR but it was associated with high dose valproate which in this case was 1200 mg /day. No known causes or mechanisms of oedema were found. The patient may have had a previously described poorly understandable mechanism of oedema which is needed to be further investigated.

Keywords: Adverse drug reaction, bipolar disorder, valproate


  CP – 14: Safety and Efficacy of Tirapazamine as Anti-Cancer Drug: A Meta-Analysis of Randomized Controlled Trials Top


Sharanabasayyaswamy B Hiremath, Srinivas LD1

Department of Pharmacology, SDM Medical College, Dharwad, 1Department of Pharmacology, JJM Medical College, Davangere, Karnataka, India

Objectives: The benefits of achieving better survival rates by adding tirapazamine, a specific hypoxic cancer cell killer as an adjuvant to chemo and or radiotherapy in patients of various cancers is controversial. Our study aims at analyzing the efficacy and safety of tirapazamine apart from understanding the reasons for its inconsistent benefits. Methods: Electronic database search in PUBMED, EMBASE, Cochrane library was conducted using search term “tirapazamine”. Randomized or cross-over studies comparing effects of tirapazamine vs other active treatment or placebo in patients >18yrs with any type of cancers were included under analysis. Overall Survival rate was the primary outcome measure while the incidences of grade-3&4 adverse drug reactions were the secondary outcome measure. Inverse variance method and both random and fixed effect models were used in the analysis by RevMan 5.3 software. Results: Total six studies were eligible with 1034 patients included in the analysis. Tirapazamine failed to show significant effect on overall survival rate at the end of one year (HR: 0.96, 95% CI: 0.88, 1.05), two years (HR: 1.04, 95% CI: 0.98, 1.12), three years (HR: 1.01, 95% CI: 0.89, 1.15) and five years (HR: 0.97, 95% CI: 0.77, 1.23) compared to placebo group. There was a significantly higher incidence of muscle cramps (Risk Difference, RD: 0.06, 95% CI: 0.02, 0.11) and dermal adverse events (RD: 0.03, 95% CI: 0.01, 0.06) in tirapazamine group. Conclusion: With the available evidences, use of tirapazamine may not be justifiable and perhaps it is too early to sideline this drug as another failed drug.

Keywords: Cancer, overall survival rate, tirapazamine


  CP – 15: Prescription Pattern of Psychotropic Medications for Non-Psychiatric Indications: A Prospective, Cross Sectional, Observational Study Top


Sonia Shinde Mahajan, Vishal R Tandon, Annil Mahajan1, Brij Mohan Gupta

Departments of Pharmacology and Therapeutics and 1Internal Medicine, Government Medical College, Jammu, Jammu and Kashmir, India

Objectives: To study the prescription pattern of psychotropic medications for non psychiatric indications. Methods: A 6 months prospective, cross sectional, observational study was conducted in a Tertiary Care Teaching Hospital. Patients who were prescribed at least one psychotropic medication were included in the study. Their demographic data, clinical history, all the medicines prescribed were noted. These prescriptions were analyzed for the off label use of psychotropic medications for non-psychiatric indications. Results: A total of 94 patients prescriptions containing psychotropic medications were picked up out of total 5280 patients screened in the Medicine OPD during study period with point prevalence of 1.78%. Mean age of such population was 47.41 ± 13.89 years with females predominating with 1.8:1 ratio. 37.22% of such population had 1 or more than 1 co-morbid conditions and hypertension followed by diabetes and hypothyroidism were the leading co-morbid conditions. Nortriptyline (39.36%), clonazepam (29.78%) and gabapentin (20.21%) were the most commonly prescribed psychotropic medications for non-psychiatric indications. The most common non-psychiatric indications encountered were neurological headache (35.10%), Restless Leg Syndrome (13.82%) and nonspecific arthralgias (9.57%). Conclusions: off label prescribing is substantially prevalent in the Medicine Outpatient Department in our set up warranting attention of drug regulatory authorities towards the basis of clinical decisions for their use.

Keywords: Off label, prescription pattern, psychotropic medication


  CP – 16: Comparitive Study of Efficacy and Safety of Gabapentin and Amitriptyline Monotherapy in Patients of Painful Diabetic Neuropathy Top


Jayesh KM Rajgopal

Gandhi Medical College, Bhopal, Madhya Pradesh, India

Objectives: The primary objective of the study is to evaluate the efficacy of gabapentin and amitriptyline and secondary objective is to evaluate the safety of gabapentin and amitriptyline in patients of diabetic neuropathy. Methods: It is an observational, open, comparative, and multiple follow up study. A total of 110 patients who were diagnosed with type 2 diabetes and who presented to the OPD with clinically relevant lower and upper limb neuropathy with significant pain and paresthesias lasting at least 3 months were enrolled in the study. Patients will be analyzed by VAS scale and Short form McGill Pain questionnaires (SFMPQ). Group A received Gabapentin and Group B received Amitriptyline. Results: A total of 101 patients completed the study. Mean age of the patients were 50.02 ± 10.00. Baseline VAS score in gabapentin group was 7.52 ± 0.99 and in amitriptyline group was 7.58 ± 0.69. After treatment final VAS score in gabapentin group was 2.25 ± 0.52 and in amitriptyline group was 2.22 ± 0.82. Baseline paresthesia score gabapentin group was 2.04 ± 0.69 and in amitriptyline group was 2.00 ± 0.75. After treatment final paresthesia score in gabapentin treated group was 0.53 ± 0.54 and in amitriptyline was 0.55 ± 0.54. There was no significant difference between the two treatment group in both VAS score and paresthesia score. Conclusions: Both the treatment group showed equal efficacy with no significant difference between the two treatment groups. A larger control trial is needed to effectively evaluate the efficacy of both drugs for clinical use with respect to their cost.

Keywords: Amitriptyline, diabetic neuropathy, gabapentin


  CP – 17: Analysis of Possible Drug Drug Interactions in Patients Undergoing Renal Transplantation in a Tertiary Care Hospital of Odisha. Top


Jigyansa Mohapatra, Abhisek PA, Swain TR, Hota D1, Nayak BB1, Mohanty S

Departments of Pharmacology and 1Urology S.C.B. Medical College, Cuttack, Odisha, India

Aim and Objectives: To assess the prevalence of possible drug-drug interactions (DDIs) in patients undergoing renal transplant surgery and to describe possible mechanisms of the DDIs and assess their frequency and severity. Methods: This prospective, observational study was conducted in the Dept of Urology in collaboration with dept of Pharmacology. Pre operative and post operative prescriptions of 25 patients were analysed during their hospital stay. Possible DDIs were analyzed using MICROMEDEX, LEXICOMP, DRUGS.COM, MEDSCAPE.COM drug interaction checker. The DDI were categorized according to their severity, possible mechanism of action and potential clinical risk. Results: Data were analysed for 25 patients undergoing renal transplant surgery. Out of which 23 pts were male and only 2 were female. Mean no of DDI in post operative phase was 9 per patient and in the pre operative phase were 11. Mean of 3 major DDI was observed per patient. Out of the total DDI found 15 % were of major category and 75% were of moderate in nature. The possible mechanisms were found to be pharmacokinetic in nature (62.5%) DDIs and 37.5% Pharmacodyanamic in nature. Conclusions: The maximum potential interactions were of moderate severity and the possible mechanisms for the DDIs were mostly pharmacokinetic in nature.

Keywords: Drug Drug Interaction, Drugs.Com, Lexicomp, Medscape.Com, Micromedex, Renal Transplant


  CP – 18: Comparative Study of Ramipril Versus Telmisartan in Type 2 Diabetic Patients and Their Effects on Microalbuminuria Top


Raj Kumar, Kazal KL1, Panag KMDS2, Kamlesh Kohli

Department of Pharmacology, GGS Medical College and Hospital (Baba Farid University of Health and Sciences), Faridkot, 1Department of Medicine, PIMS, Jalandhar, 2Department of Biochemistry, GMC, Patiala, Punjab, India

Objective: To evaluate the effects of Ramipril and Telmisartan on the Blood Pressure, serum creatinine, albuminuria and other parameters. Materials and Methods: This was a randomized, open labeled, parallel study conducted to assess the effect of Ramipril (2.5-10 mg) and Telmisartan (20-80 mg) daily for 24 weeks in T2DM patients (n=40). Patients were recruited from department of Medicine OPD/Ward in the GGS Hospital and medical college, Faridkot. Subjects in the age group of 30- 80 years who had T2DM with or without hypertension were enrolled and randomly divided into two groups viz. Group A (Ramipril 2.5 to 10 mg/day) and Group B (Telmisartan 20-80mg/day). Patients were evaluated at day 0 and at 12 and 24 weeks for Blood pressure, S. Creatinine, albuminuria and other routine investigations. Results: At 24 weeks SBP, DBP, Pulse rate and albumin in urine were decreased (mean percentage change) in Group A and Group B by 12.60 vs. 18.85, 12.12 vs. 16.08, 1.56 vs. 1.7 respectively. These decreased in values of SBP, DBP, Pulse rate and albumin in urine were significant in both the groups (p <0.001, each) at 24 weeks, when both the groups were compared these decreased in values were insignificant (p>0.05). Conclusions: Both ramipril and telmisartan are equally effective in improving SBP, DBP, pulse rate in T2DM patients. Both agents also improve the markers of renal disease (viz. albumin level in urine) in T2DM patients. Therefore, both agents also having renoprotective action beside their antihypertensive action which can be used rationally as well as prophylactically to prevent the decline in the renal function in patients of T2DM cases.

Keywords: Angiotensin converting enzyme inhibitor, angiotensin receptor blocker, blood pressure, renoprotective agents, type 2 diabetes mellitus


  CP – 19: An Observational Study to See the Effect of Comorbidity on Antimicrobials Prescription in Intensive Care Unit of a Tertiary Care Hospital Top


Hussain S, Sawlani KK1, Bajpai M2, Kumar V3, Pant KK, Khattri S

Departments of Pharmacology, 1Medicine, 2Physiology, 3Plastic Surgery, King George's Medical University, Lucknow, Uttar Pradesh, India

Objectives: To assess the effect of comorbidity on the antimicrobials prescription in the intensive care unit. Methods: This prospective observational study was conducted at the Intensive Care Unit (ICU) of the department of Medicine. The WHO ATC/DDD classification system was used for classification of the antimicrobials. The Charlson comorbidity index was used for grading of comorbidity into the four groups: no comorbidity (0), mild (1-2), moderate (3-4) and severe (>4). The Kruskal Wallis test was used for comparing between the groups. Results: A total of 101 patients were analyzed. Our study revealed the significant difference in the antimicrobials DDD, number and cost per patient (p<0.05). There is also a significant difference between groups for the antimicrobials DDD per day per patient (p<0.05), but not for the Antimicrobials number and cost per day per patient. Conclusions: The comorbidity was significantly affecting the antimicrobials DDD, number, cost per patient and the antimicrobials DDD per day per patient.

Keywords: Anatomical therapeutic chemical, charlson comorbidity index, defined daily dose


  CP – 20: A Multi-Centric Placebo Controlled Double Blind Clinical Study to Assess the Reduction in HbA1C with Novel Fenugreek Seeds Extract (FenfuroTM) in Patients with Type-2 Diabetes: An Add-On Study Top


Narsingh Verma, Awasthi V, Jain A, Dhakre S1, Goel PK2, Lamgora F2

Department of Physiology, KGMU, Lucknow, 1Jain Clinic, Agra, Uttar Pradesh, 2R and D Chemical Resources, Panchkula, Haryana, India

E-mail: [email protected],

Background: Clinical evaluation of FenfuroTM a novel Fenugreek seed extract demonstrated the broad spectrum safety and efficacy in type 2 diabetes subjects in our earlier studies. Objective: To Assess the Reduction in HbA1C with FenfuroTM in the management of Type 2 Diabetes Methods: This multi-centric, randomized, placebo-controlled, double-blind, add-on clinical study evaluated the Reduction in HbA1C with FenfuroTM (daily dosage: 500 mg BD) in 154 male and female subjects (male: 108; female: 46; age: 25-60 years) with Type 2 Diabetes over a period of 3 months. This study evaluated the efficacy of FenfuroTM on FBS and PPBS and HbA1C levels. Results: In FenfuroTM treated group, the reduction was 19.8%, where as in Placebo treated group, the reduction was 16.48 % of the respective baseline values. Over all 48.8% subjects reported reduced dosage of Oral Hypoglycemic Agents in Fenfuro treated group, against 18.05% in the placebo-group. There was 22% decrease in fasting blood sugar and 30.7% decrease in prandial value. Overall 83% patients reported decrease in FBS and 89% reported decrease in PPBS. Fenfuro caused significant reduction in the fasting and prandial blood sugar. Extensive blood chemistry analysis was conducted to exhibit the broad spectrum safety of FenfuroTM. No apparent significant adverse effects were observed. The Liver and Kidney function tests showed no significant difference in placebo and Fenfuro treated group. Conclusion: FenfuroTM was efficacious in ameliorating the symptoms of Type 2 Diabetes without any increase in drug related side effects.


  CP – 21: Adverse Drug Reaction Monitoring at a Regional Pharmacovigilance Centre (B.P.K.I.H.S.) Top


Rauniar GP, Panday DR1

Departments of Clinical Pharmacology and 1Therapeutics, Regional Pharmacovigilance centre, BPKIHS, Dharan, Nepal

Introduction: Adverse drug reactions (ADR) are unintended drug consequences which are often preventable. ADR monitoring is the cornerstone of Pharmacovigilance. Pharmacovigilance plays an important role in rational use of drugs. This study was to observe the pattern of ADRs at Eastern Regional Pharmacovigilance Centre of Nepal, (B.P.Koirala Institute Health Sciences) Materials and methods: It was a cross-sectional study of clinician-diagnosed ADR among patients presented to BPKIHS between July 2012 to July 2015. 150 ADRs from different departments of the Institute were collected and analyzed in the department of clinical pharmacology and Therapeutics, Regional Pharmacovigilance Centre. Results: There were total 150 ADRs reported among patients during 3 years monitoring period. Highest percentage of ADR was collected from Department of Psychiatry (60.67%). Maximum number of ADRs observed were due to CNS drugs (64.66%) followed by endocrinal drugs (17.33%) and antimicrobial drugs (12.00%). ADR due to steroid (16.67%), i.e., Headache, Insomnia, puffiness of face, acid peptic disorder, oral candidiasis etc. and diverse CNS drugs related ADRs (14.66%) e.g. dryness of mouth, sexual dysfunctions etc. were the most common ADRs seen. Conclusion: CNS drugs related ADRs were most commonly observed. Careful monitoring, better reporting and dedicated follow up of the patients might lead to more and better ADR detection.

Keywords: Adverse drug reactions, B. P. Koirala Institute Health Sciences, pharmacovigilance


  CP – 22: Serum Lipid and Lipoprotein Levels During the Follicular and Luteal Phase of Menstrual Cycle Top


Vashishta S, Gahlot S, Singh A1, Goyal R, Matreja PS2

Departments of Physiology, 1Gynecology and 2Pharmacology, Gian Sagar Medical College and Hospital, Patiala, Punjab, India

Objectives: It is assumed that cyclical fluctuations in levels of sex hormones during a menstrual cycle may possibly have an impact on lipids, lipoprotein levels and therefore on cardiovascular health status of females. The objective was to ascertain the influence of menstrual cycle phase on the levels of cardiovascular risk predictors in healthy menstruating women. Subjects and Methods: The study examined one hundred and eleven healthy menstruating females aged 15-45 years at two points of a menstrual cycle i.e. in the follicular phase(10th day) and in the luteal phase(22nd day) to find out the serum levels of lipid and lipoprotein. The data was statistically analyzed using paired t-test. Results: A significant decrease in the mean levels of TC, LDL-C, TC/HDL, LDL/HDL, and TG/HDL was observed in the luteal phase compared to the follicular phase while TG, HDL-C & VLDL-C did not showed a significant difference although lower levels were observed in the luteal phase of TG and VLDL-C and higher levels for HDL-C. Conclusion: These differences may be due to high levels of estrogen in the luteal phase compared to follicular phase of menstrual cycle. Therefore even in healthy menstruating females there are cyclic fluctuations in serum levels of lipids and lipoprotein during different phases of menstrual cycle. So clinicians should take menstrual cycle phase into consideration when inferring a women biomarker measurement in the analysis of cardiovascular disease, particularly females possessing marginal levels.

Keywords: Biomarkers, cardiovascular diseases, gonadal steroid hormones, women's health


  CP – 23: Antibiotic Audit in ICU Patients of a Tertiary Care Hospital of Northern India Top


Kaur G, Arora S, Gupta K, Kaushal S

Department of Pharmacology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India

E-mail: [email protected]

Objective: Increased use of antimicrobials, especially in a tertiary care hospital, has led to development of resistance, increased morbidity and length of hospital stay. This study was conducted to audit antibiotic prescribing pattern in the ICU of a tertiary care hospital in North India. Materials and Methods: After taking approval from the Institutional Ethics Committee, an observational study was conducted for a period of 7 months i.e. from 16th December 2015 to 15th July 2016. Audit of antibiotic prescription was done by reviewing prescriptions and patient files. Clinical and laboratory details were matched with antibiotic prescribing, and the appropriateness of the latter was judged. The data so collected was entered in a semi-structured performa and then analyzed. Results: A total of 182 prescriptions were audited. Culture sensitivity reports were available for 65.42% of the prescriptions. Errors were found in 22 prescriptions (12.08%) . Out of these 22 prescriptions, there were 20 cases (10.98%) of over prescription of antibiotics and 2 prescriptions ( 1.1%) in which culture was positive for fungal growth but still antifungal drugs were not prescribed. Conclusion: Antimicrobials are being used irrationally at times. Standard treatment guidelines for their judicial use as well as antibiotic stewardship program are required. Avoiding their unnecessary use will help to prevent resistance, improve patient outcomes and minimize financial burden. Antibiotic audits at regular intervals or at random can play an important role in guiding the clinicians in achieving these objectives and present a true picture.


  CP – 24: Retrospective Analysis of Pattern of Adverse Drug Reactions in Tertiary Care Hospital Top


Goyal PK, Mahajan B, Kaur G, Kaushal S

Department of Pharmacology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India

Introduction: Adverse Drug Reactions (ADRs) can cause serious harm to patients. Pharmacovigilance can help to add up the ADRs Database. Aims and Objectives: 1. To evaluate the ADRs reported from various departments 2. To establish their causality according to WHO causality assessment scale Methodology: The retrospective study was conducted in ADR monitoring centre in Dayanand Medical College & Hospital. All ADRs reported from June 2016 to September 2016 were collected, analysed and causality assessment was done. Findings: A total of 126 ADR's were reported from various departments out of which maximum ADR's are reported from dermatology department (29.3%) followed by oncology (26.9%), medicine (14.3%), psychiatry (11.1%), radiology (11.1%) . Maximum number of ADRs are caused due to antineoplastic agents (27.8%) followed by antimicrobial agents (22.2%) and contrast Agents (11.1%). Other classes of drugs causing ADRs are antipsychotic agents (11.1%), antiepileptic drugs (8.7%), antitubercular drugs (4.8%) and NSAIDS (3.1%). Most common ADRs among different classes as follows- Antineoplastics: fever (17.1%), breathlessness(14.3%) ; Antimicrobial agents: mild rash(35.7%), SJS/TEN (14.3%); Contrastagents:shivering(42.9%),Rashes(35.7%); Antipsychotics: Dystonia(71.4%), slurred speech (14.3%) ; Antiepileptics: mild rash(63.6%) , TEN(18.2%). About 53.9% of all ADRs reported are due to High Risk Medications. About 23.01% of total ADRs are serious. According to WHO causality scale, 82.5% of ADRs are probable, 16.7% are possible, 0.7% are certain. Conclusion: Most of ADRs are due to anticancer drugs and antimicrobial agents. There is a need to create awareness among health professionals to detect ADRs early and report to fulfill the dream of Pharmacovigilant India and safe drugs for our patients.

Keywords. Adverse Drug Reactions, WHO causality scale, Pharmacovigilance


  CP – 25: Comparative Study of L-Asparaginase Activity of Six Different Biosimilars versus the Innovator in Pediatric Patients with Acute Lymphoblastic Leukemia Top


K Manjunath N, Vaitashi Purohit, Vikram Gota, Brijesh Aurora1

Department of Clinical Pharmacology, ACTREC, Tata Memorial Centre, 1Department of Pediatric Oncology, Tata Memorial Hospital, Tata Memorial Centre, Mumbai, Maharashtra, India

Introduction: To be considered “interchangeable,” biosimilars must (along with some other requirements) be expected to produce the same clinical result as the reference product in any given patient. L-Asparaginase is the cornerstone of treatment protocols for acute lymphoblastic leukemia (ALL). Serum asparaginase activity of >100 IU/L is required for adequate asparagine depletion (ie below the level of quantification)https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3000881/ - R27 and therefore is often considered the target trough asparaginase activity. We studied the possibility of interchangeability of biosimilars of L–Asparaginase w.r.t the innovator. Methodology: This was an observational study to capture the trough activity of L-Asparaginase in Pediatric ALL patients (aged 1-18yrs) receiving standard dose Leunase or its biosimilars (BS 1 to BS 6). Results: We analyzed 133 blood samples. With Leunase, the mean (±SD) trough activity of L-Asparaginase were 538.8± 404.25 U/L, while the activity with other biosimilars BS 1 to 6 were 107.84±37.61, 86.29± 11.37, 141.53± 281.55, 65.52± 46.53, 34.78± 16.3 and 120.41± 100.89 U/L respectively. It was also found that in 10 patients treated with BS1 and BS2 after Leunase, L-Asparaginase levels fell drastically down to 137.94±125.76 and 176.88±288.84 U/L respectively from 557.8±420.9 U/L. Total number of patients achieving the target levels of L-Aparaginase in different biosimilars were 32 out of 120 patients i.e., 6/37 (BS1), 10/33 (BS2), 4/12 (BS3), 2/10 (BS4), 0/10 (BS5) and 10/18 (BS6). Conclusions: We could not find an interchangeable biosimilar to Leunase. Therapeutic drug monitoring of L-Asparaginase is important in curable conditions like ALL as the target levels were achieved in just one-fourth of patients on biosimilars.

Keywords: Biosimilar, interchangeable, L-Asparaginase, Leunase


  CP – 26: To Study the Acceptance of Nicotine Gums by Tobacco Smokers for Smoking Deaddiction Top


Neetu Bala, Parveen Kumar Sharma, Dinesh Kansal, Rekha Bansal1, Rajan Negi, Himani

Departments of Pharmacology and 1Pulmonary Medicine, Dr.R.P.G.M.C, Kangra at Tanda, Himachal Pradesh, India

Objective: To study the acceptance of nicotine gums by tobacco smokers for smoking Deaddiction. Methodology- It was a prospective interventional study of 1.5 yrs duration conducted in Dr. RPGMC Kangra at Tanda from April 2015 to September 2016. All current smokers attending pulmonary medicine OPD willing to quit smoking were enrolled. Baseline counseling was provided. Nicotine gums were prescribed as, for first 6 weeks 1-2 hourly, next 2 weeks 2-4 hourly, last 3weeks every 6 hourly for total 3months duration. Four face to face Counseling or telephone counseling sessions were conducted and various parameters of gum use were recorded on structured Performa. Results- Total 86 smokers were enrolled. 65(76.5%) used nicotine gums, only 2(3%) completed 3months duration therapy rest 63(97%) stopped prematurely. Reasons for pre mature discontinuation of nicotine gums were, smoking continued with nicotine gums/ Ineffective 20(31%), side effects 15(23%), no longer needed 12(18.5%), dysgeusia 7(11%), cost 6(9.2%), situational stress and family problems 3(4.6%). 15(17.4%) smokers did not use nicotine gums and the reasons were, want to quit with will power 7(47%), reason not given 4(27%) and others 3(20%). The side effects recorded with nicotine gums were nausea 6(9.2%), hiccups 5(7.6%), dizziness 3(4.65%), vomiting 3(4.6%), anxiety 1(1.5%), headache 1(1.5%). Conclusion- Nicotine gums are not easily accepted for quitting smoking by smokers.

Keywords: Nicotine gums, smoking deaddiction, tobacco smoking


  CP – 27: Association Serum Adiponectin and TNF-α Level with Metabolic Syndrome in Patients Receiving Antipsychotic Drugs Top


Raghunath Singh,Bikash Medhi1, Subho Chakrabarti2, Sandeep Grover2, Yashika Bansal, Priyanka Saroj, Anurag Kuhad

Division of Pharmacology, University Institute Pharmaceutical Sciences, Panjab University, Departments of 1Pharmacology and 2Psychiatry, PGIMER, Chandigarh, India

E-mail: [email protected]

Objective: Tumor necrosis factor alpha (TNF-α) is a proinflammatory cytokine having multifunctional role inpathogenesis of metabolic syndrome (MetS), insulin resistance and obesity whereas adiponectin, released from adipose tissue and regulates glucose levels and fatty acid oxidation. With this background the present study was aimed to investigate their association MetS in patients receiving antipsychotic drugs. Materials and Methods: 220 patients satisfying inclusion and exclusion criteria were enrolled for the study, after getting informed consent.Sociodemographic and anthropometric data were collected with questionnaire. International Diabetes Federation (IDF) criteria for assessment of MetS were followed. TNF-α and adiponectinlevels were assessed in serum samples of the patients. Results: The study included 220 (143 male and 77 female) patientsamong them,disease wise distribution was; schizophrenia>bipolar disorder>schizoaffective disorder>psychotic depression>psychosis NOS. Prescription pattern of antipsychotic drugs was; clozapine>olanzapine>trihexyphenidyl>risperidone>aripiprazole>quetiapine>amisulpride>zipras-idone. Percentage withMetS was found to be 47%with highest contribution by olanzapine followed by risperidone, clozapine andaripiprazole. IncreasedTNF-α level and decreased adiponectin levels were foundin patient with MetS as compared to patients without MetS. Conclusion: Elevated serumTNF-αand reduced adiponectin in patient treatedwith antipsychotic drugs maybe associated with altered metabolic parameters and increased BMI.

Keywords: Adiponectin, antipsychotics, insulin resistance, metabolic syndrome, tumor necrosis factor alpha


  CP – 28: Co-Relation of Salivary Microbial Counts with Clinical Parameters Following Anti-Microbial Therapy in Pediatric Patients: A Prospective Study Top


Ravishankar Maurya, Alok Singh, Srivastva VK1, Gopal Nath2, Pandey BL

Departments of Pharmacology, 1Pedodontics and 2Microbiology, Institute of Medical Sciences, Banaras Hindu University, Uttar Pradesh, India

Objective: Oro-dental infections like dental caries, gingivitis and periodontitis are the most commonly encountered disease in pedodontic patients. Anti-microbial therapy remains the mainstay of treatment along with supportive treatment. Cefixime, Doxycycline and Levofloxacin are broad spectrum antibiotics and usually used in dentistry practice. In the present study, these three drugs were observed for clinical recovery along with microbial counts in saliva of pediatric patient. The aim was to establish correlation between clinical recovery with microbial counts. Materials and Methods: Total 150 patient were selected for antimicrobial therapy. 50 patient were subsequently allocated to group A, B and C. Cefixime, Doxycycline and Levofloxacin was given to group A, B and C respectively. Pediatric patients of age group from 3-12 years with oral and dental problem requiring use of antimicrobial with clinical diagnosis of dental carries, gingivitis, root stump, and dental abscess were included in the study. Clinical therapeutic benefits were measured in form of reduction in pain and gum swelling. Microbiological benefit was assessed by counting total salivary bacterial counts before and after treatment in case of each Antimicrobial therapy Results: Oro-dental pain, swelling and salivary bacterial counts significantly reduced in case of Doxycycline and Cefixime while in case of Levofloxacin the results were not significant. Doxycycline performed superior to all three antibiotics. Conclusion: Cefixime, Doxycycline and Levofloxacin were broad spectrum agents used alone essentially by subjective choice of clinician. Clinically as well as microbiologically, the anti-infective treatment was successful. The successful outcome despite essentially empirical approach in dental treatment of infection is subject for further detailed understanding with large epidemiological, clinical and laboratory research.


  RDU (RATIONAL DRUG USE) Top



  RDU – 1: Study of Adverse Drug Reaction in Dermatology Department of M.Y. Hospital, Indore Top


Vatsala Maheshwari, Pooja Solanki Mishra, Shubham Atal, Sanjay Khare1

Department of Pharmacology, MGM Medical College, 1Department of Dermatology, M.Y. Hospital, Indore, Madhya Pradesh, India

Objective: Primary: To evaluate the frequency and seriousness of Adverse Drug Reactions (ADRs)among patients reporting to dermatology department of M.Y. Hospital, Indore Secondary: 1.To evaluate the distribution of ADRs according to age ,sex,indication,drug prescription 2.To evaluate the most common type of ADRs and most common drugs leading to ADRs in dermatology Methods: A prospective,observational study was conducted in patients presenting to dermatology department,of M.Y. Hospital , Indore during a period of 6 month from December 2015 to May 2016.First hundred patients of ADRs recognized by consultants were interviewed by investigator ,regarding age ,type of ADR, starting date of ADR, indication of suspected drug intake, including history of suspected drug intake,duration ,frequency etc.The data was analysed by simple percentage method. Results: Among first 100 patients presenting to dermatology department, there was no significant difference between male and female distribution of ADR. Topical steroids were most offending drug followed by NSAIDs. Topical steroid damaged face is most common presentation followed by Tinea Incognito. Conclusion: The self medication and availability of over the counter drug were identified as most common cause of ADR. Both are preventable, if strict regulations are made and people are educated properly about the harm caused by irrational use of drugs. Also there is a need to report all thesuspected ADR by health care professionals to make regulatory decisions.

Keywords: Over the counter drug, PvPI, self-medication, tinea incognito, TSDF


  RDU – 2: Pharmacovigilance of First Line Antitubercular Therapy in Category-I Patients of Pulmonary Tuberculosis Top


Rahul Agarwal, Ashok Goel, Jaswant Rai, Kajal NC1

Departments of Pharmacology and 1Chest and TB, GMC, Amritsar, Punjab, India

Objectives: Tuberculosis is an infectious disease and a global health concern. Its treatment with multi-drug regimens is associated with a wide range of adverse drug reactions(ADR's). The objective was to study the demographic details and incidence of various adverse drug reactions in Pulmonary tuberculosis patients on DOTS category-I . Methods: This prospective observational study was conducted in Chest and TB department of GMC Amritsar, India with ethical committee clearance and informed consent from patients. Pharmacovigilance study was conducted in 100 patients with pulmonary tuberculosis on DOTS category -I and follow up done at 30 days and 60 days to study incidence of ADR's. The causality and severity of the reaction were determined using WHO causality assessment and Hartwig questionnaire. Results: Out of total 100 patients enrolled in study, 81(81%) developed ADR's. Incidence of various ADR's were: Gastro-intestinal reactions 31(38.27 %), hepatitis 25(30.86%), rash 11(13.58%),CNS problems 8(9.87%), visual disturbance 2(2.46%) and hyperuricemia 3(3.70%). WHO Causality assessment of ADR's revealed that 78(96%) cases were probable and 3(3.7%) were certain. As per Hartwigs severity assessment, 57(70.37%) ADR's were moderate, 20(24.69%) mild, 4(4.93%) severe. Conclusions: The high incidence of ADRs in Tuberculosis may steer the patient to make a judgment for interrupting the medication leading to emergence of drug resistance and an amplified health care cost. The study findings call for intensive training of DOT providers and medical personnel for early ADR identification. A proper Pharmacovogilance system implemented in the programmatic settings, would encourage better ADR reporting, improved patient adherence and treatment outcome.

Keywords: Adverse drug reactions, DOTS, tuberculosis


  RDU – 3: A Comparative Study of Glycopyrollate and Ondansetron for the Control of Post Operative Nausea and Vomiting Following General Anaesthesia Top


Afreen Fatima, Mamatha KR, Prabha P1

Departments of Pharmacology and 1Anaesthesiology, Bangalore Medical College and Research Institute, Bengaluru, Karnataka, India

Background : Postoperative nausea and vomiting (PONV) is a common distressing problem in patients undergoing surgery under general anaesthesia which requires frequent medical interventions. Objectives : Primary objective was to find out the efficacy of glycopyrrolate & ondansetron in prevention of PONV in patients undergoing surgery under general anaesthesia. Methods: This was a prospective, randomized, placebo controlled study conducted in Victoria & Bowring hospital. Study subjects were randomly assigned into three groups of 10 patients each. Group G received inj Glycopyrrolate 0.2 mg i.v, Group O received inj. Ondansetron 8 mg i.v, Group N will receive 1 ml normal saline i.v, just before induction of anaesthesia with Inj.Fentanyl & inj. propofol. Incidence of nausea & vomiting was assessed for 24 hrs after surgery. Results: Out of 30 patients 12 (40%) patients had nausea and vomiting in the postoperative period i.e Three (10%) patients in group G, two (6.67%) in group O & seven (23.34%) in group N. Incidence of nausea was compared between glycopyrrolate & saline (OR= 0.214, CI= 0.02-1.8, P= 0.164), Ondansetron & saline (OR= 0.0938, CI= 0.007-1.2, P= 0.07). Whereas occurrence of vomiting between Glycopyrrolate & saline (OR= 0.14, CI= 0.01-1.9, P= 0.14), Ondansetron & saline (OR= 0.12, CI= 0.009-1.7, P= 0.12). Conclusions: Our study showed that prophylactic use of ondansetron is discreetly effective in the prevention of PONV. As this is an on-going study the results are being awaited.

Keywords: General anaesthesia, glycopyrrolate, ondansetron, postoperative nausea and vomiting


  RDU – 4: Drug Utilization Pattern and Pharmacoeconomic Analysis in Intensive Care Unit in A Tertiary Health Care Institution Top


Adhikari Karishma, Phukan Swopna

Department of Pharmacology, Gauhati Medical College, Guwahati, Assam, India

Objectives: To evaluate drug utilization pattern, pharmacoeconomic analysis and prevalence of antibiotic resistance in patients admitted in Intensive Care Unit. Methods: It was a retrospective, observational hospital based study which was done for 1 year after obtaining permission from the Institutional Human Ethics Committee. The prescriptions of both genders and of any age groups suffering from any medical or surgical indication who were admitted in Intensive Care Unit were included. The parameters assessed were demographic profile of the patient, most common diagnosis, number of days of ICU stay, ICU outcome, number of drugs/prescription, most common group and route of drugs, total cost on ICU stay/patient and antibiotic resistance. Results: Data from 840 prescriptions were analyzed using appropriate statistical method and 70% patients were male. Most common age group was 41-60(44.5%). Cerebrovascular accident (22.1%) was the most common diagnosis followed by septicaemia (15.7%). Average no. of days of ICU stay was 6.3 days/patient. ICU mortality rate was 58.6% which was the most common outcome. At an average 15.8 drugs were prescribed per patient. Antibiotics and proton pump inhibitors were the most commonly prescribed drugs in 100% prescriptions, ceftriaxone (37.1%) being the most common antibiotic. Most common route of drug administration was intravenous route (65%). An average total cost on ICU stay is Rs 11035/person. Antibiotic resistance was reported in 25.7% patients mostly by klebsiella in sputum and tracheal swab culture. Conclusion: Prescribing guideline is required to reduce the prevalent poly-pharmacy and to promote appropriate use of antimicrobials based on the culture and sensitivity report.

Keywords: Drug utilization, pharmacoeconomic analysis, intensive care unit


  RDU – 5: A Study to Compare the Effect of Amlodipine and Cilnidipine on Blood Pressure in Patients with Chronic Kidney Disease. Top


Farrukh Hussain Kidwai, Raj Kumar Goel, Singh RR1

Department of Pharmacology, Hind Institute of Medical Sciences, 1Department of Medicine, Hind Institute of Medical Sciences, Barabanki, Uttar Pradesh, India

Objectives: Comparison between Amlodipine and Cilnidipine on blood pressure in chronic kidney disease patients attending Medicine outpatient department at Hind Institute of Medical Sciences,Barabanki. Materials and Methods: After taking approval from Institutional Ethics Committee, this randomized study was conducted over 60 patients after taking informed consent. Patients were randomly recruited into two groups. One group was given Tablet Amlodipine 5 mg orally while other group was given Tablet Cilnidipine 10 mg orally. The blood pressure monitoring was done at 0 week (time of booking the patient), 4 week, 8 week and 12 week. p-value < 0.05 was considered significant. Results: The systolic blood pressure was 164 ± 12 mmHg at 0 week, which decreased to 148±10 at 12 weeks while diastolic blood pressure decrease to 90± 6 mmHg at 12 week from 98± 8 mmHg at 0 week with Amlodipine. The mean Systolic Blood pressure level was 164 ± 11 mmHg at 0 week, which decline 146±10 at 12 weeks while diastolic blood pressure decrease to 92± 6 mmHg at 12 week from 100± 8 mmHg at 0 week with Cilnidipine. Conclusions: Once daily use of Amlodipine or Cilnidipine significantly reduced the blood pressure. The present study demonstrated that Cilnidipine was equally efficacious in lowering BP, while it more effectively reduced HR as compared to Amlodipine.


  RDU – 6 : A Study on Prescribing Patterns of Antihypertensive Drugs in Cardiology In-Patient Department at A Tertiary Health Care Institution, Assam, India Top


Dibyajyoti Deka, Diptimayee Devi

Department of Pharmacology, Gauhati Medical College, Guwahati, Assam, India

Objective: To study the prescription patterns of antihypertensive drugs in a tertiary care hospital with special reference to mono and multi-drug regimens Methods: A retrospective, cross sectional analysis of antihypertensive prescriptions was done which included all prescriptions of hypertensive patients admitted in Cardiology inpatient wards of the hospital during the period of January 2016 to June 2016. Patient case records were collected from Medical Records Department of our Hospital and reviewed to extract data on the pattern of antihypertensive drug use. Collected data were analyzed using Microsoft Office Excel Sheets. Results: A total of 140 prescriptions were analyzed. 106 (76%) were male patients and 34(24%) were females. Maximum hypertensives were seen in the age group of 60-69 in both sexes and the least were seen in the age group of 20-29 in males and 30-39 in females. Out of the total patients, 38 patients (27%) received monotherapy and 102 (73%) of them received combination therapy. Calcium channel blockers were the most commonly prescribed monotherapy. Two drug CVS combination received by 50 patients (49%), followed by 3 drugs combinations (44 patients,43%) and 4 drugs combination (8 patients,8%) Conclusion: This study shows that the prescribing practices for antihypertensives are inconsistent with the international guidelines. Most of the patients received combination therapy. Further studies needed for rational drug choice based on economic status, co morbidities, that would give additional information.

Keywords: Antihypertensives, mono and multi-drug therapy, prescribing patterns

[TAG:2]RDU – 7: Study of Medication Adherence and Quality of Life in Children with Epilepsy [/TAG:2]

Karan Shah, Zankhana Parmar, Nitish S Vora1, Darshana Naik1, Supriya Malhotra

Department of Pharmacology, Smt. NHL Municipal Medical College, 1V.S.Hospital, Ahmedabad, Gujarat, India

Objectives: This study was aimed to assess the pattern of use of antiepileptic drugs (AEDs) in paediatric patient population diagnosed to suffer from epilepsy and to find out extent of adherence to AEDs in children and effects of the disease per se on quality of life in children suffering from epilepsy. Materials and Methods: A rospective cross-sectional study was carried out over period of one year .All children(8-12 years) diagnosed to suffer from epilepsy for at least one year and attending outpatient department of pediatric neurology were enrolled in the study after explaining the aim of the study.The Morisky Medication Adherence Scale (MMAS-8) for adherence to antiepileptic drug therapy was filled by interviewing parents and KIDSCREEN-10 questionnaire for quality of life was filled up by interviewing the pediatric patients .The correlation between these two is calculated by Spearman Correlation Coefficient. Results: Out of 150 patients 90 were male. About 47.3% reported positive perinatal history. Among traditional AEDs, Sodium valproate (39.8%) was the most commonly prescribed drug and amongst newer AEDs Oxcarbazepine (7.3%) As far as the extent of adherence to AED therapy is concerned 47.3% of paediatric population were highly adherent to prescribed drugs. As far as HRQOL is concerned, only 28% of respondents reported low quality of life scores corresponding to depressed mood. Around 39% of respondents also have low scores in questions related to performance in school. Conclusions: 74.6% of paediatric patients suffering from epilepsy received single AED. Medication adherence and quality of the life are positively correlated. Patients with high medication adherence had good quality of life and vice versa.

Keywords: Anti-epileptic drugs utilization, HRQOL, medication adherence, paediatric epilepsy


  RDU – 8: Inotropic Drugs Utilization in Intensive Care Units in a Tertiary Care Teaching Hospital Top


Naga Nandini B1, Srinivasa Rao R2, Usha Kiran P3, Tirumala Rao MVV4, Mahalakshmi R5

Departments of Pharmacology, General Medicine and General Surgery, Rangaraya Medical College, Kakinada, Andhra Pradesh, India

Aims and Objectives: The goal of the study is to identify drug utilization pattern of inotropic agents in terms of efficacy, compliance and cost effectiveness in intensive care units of a tertiary care hospital. Materials and Methods: A prospective observational study was conducted during April 2016 to June 2016 in Government General Hospital, Rangaraya Medical College, Kakinada in medical and surgical ICUs. Inotropic drugs studied are Dopamine, Dobutamine, Noradrenaline, Adrenaline, Amiodarone and Phosphodoesterase inhibitors. Drugs are classified using WHO based Anatomical Therapeutic Chemical (ATC) classification system and drug utilization was measured as Daily Defined Dose (DDD)/100 bed-days. Results: DDD/100 bed-days of inotropes was 27.3 in medical ICU which was higher compared to surgical and neurosurgical ICUs. Among inotropes, DDD/100bed-days of Dopamine is 44.23 highest in MICU, Dobutamine is 5.91, Adrenaline is 0.79, Noradrenaline is 0.14, Amiodarone is 0.08, Phosphodiesterase inhibitors is 0. Conclusions: Dopamine is the most widely used inotropic agent as it compiles with the efficacy, safety parameters and also cost effectiveness.

Keywords: Anatomical therapeutic chemical, daily defined dose, dopamine, ICU, inotropic agents


  RDU – 9: An Evaluation of the Prescribing Patterns for Under-Five Patients in Paediatric Department in Tertiary Care Teaching Hospital, Kakinada Top


Deepthi Rani B1, Usha Kiran P2, Manikyamba3

Departments of Pharmacology and Paediatrics, Rangaraya Medical College, Kakinada, AndhraPradesh, India

Introduction: To achieve quality of health and medical care, appropriate prescribing and use of medicines is important. Irrational use of drugs is one of the causes for adverse effects especially in infants and children. WHO has developed indicators to assess standardized use of drugs Objective: To evaluate the drug prescribing patterns among under five children in Paediatric department of Tertiary health care hospital Materials And Methods: A retrospective observational study of 188 prescriptions selected by random sampling was conducted at the time of admission in Paediatric department of Tertiary care hospital, GGH ,Kakinada, AndhraPradesh. Five measurements were used to assess the rational drug use: average number of drugs per encounter, percentage of encounters with an antibiotic prescribed, percentage of encounters with an injection prescribed, percentage of drugs prescribed by generic name and percentage of drugs prescribed from National Essential Medicines List. Index of Rational Drug Prescribing (IRDP) was used as an indicator of rational drug use. Calculations were done using Microsoft Excel. Results: The average number of medicines per prescription was 3.97. The percentage of generic prescriptions was 70%, 64% antibiotic, 30% injection prescriptions. The percentage of medicines prescribed from National Essential Medicines List was 75%. Commonly Prescribed drugs were Vitamins(75%) and Antibiotics(60%). The IRDP was 2.54 instead of 5. Conclusions: It is observed that, under five children prescription patterns in Tertiary Care Hospital were less compliant with IRDP. Awareness of IRDP guidelines and interactional group discussions among Paediatric consultants should be conducted to achieve rationality.

Keywords: Antibiotics, injections, rational prescribing, under-five children


  RDU – 10: Evaluation of Knowledge, Practices and Adherence Towards the Therapy in Patients of Chronic Kidney Disease. Top


Yogesh B Magar, Rajesh S Hiray, Balasaheb B Ghongane

Department of Pharmacology, B.J. Government Medical College and SGH, Pune, Maharashtra, India

E-mail: [email protected]

Objective: Chronic kidney disease (CKD) is a prolonged illness with co-morbidities. These patients have to take a large number of pills per day. Hence, this study evaluates the extent of medication adherence and study factors responsible for the same. Materials and Methods: A prospective, cross-sectional, questionnaire based study was conducted in a tertiary care hospital. Patients (n = 100) suffering from CKD for three months or more were interviewed. Morisky medication adherence questionnaire was used to assess overall adherence. Scoring was done accordingly: high (score =0), medium (score 1-2) and