EVALUATION OF TEST FORMULATION FOR ANTI-ULCERATIVE ACTIVITY USING INDOMETHACIN INDUCED ULCER IN EXPERIMENTAL RAT

                                                                STUDY PROTOCOL 

EVALUATION OF TEST FORMULATION FOR ANTI-ULCERATIVE ACTIVITY USING INDOMETHACIN INDUCED ULCER IN EXPERIMENTAL RAT

1.0 INTRODUCTION:

Gastric ulceration is a benign lesion on the mucosal epithelium upon exposure of the stomach to excess acid and aggressive pepsin activity. It possibly due to disturbance in balance between the aggressive factors like pepsin, acid and H. pylori and the defensive factors such as bicarbonate, gastric mucus, and prostaglandins.

 

2.0 TEST SYSTEM DETAILS:

Species             : Rattus norvegicus

Strain                : Sprague dawley; Wistar.

Age                   : 6-8 Weeks

Body Wight        : 150-200g

Sex                   : Male or Female

No. of animals    : 8 /Group

Total animal       : 56 + 5 Extra = 61

3.0  ALLOCATION OF GROUPS:

Groups	Treatment	Dose; ROA	No. of Animals
G1	Normal Control	0.9% Normal saline /Na-CMC	8
G2	Ulcerated Control	0.9% Normal saline/Na-CMC	8
G3	Reference Drug- Omeprazole	30 mpk; p.o.	8
G4	Test Formulation-1	X mpk; p.o.	8
G5	Test Formulation-1	XX mpk; p.o.	8
G6	Test Formulation-1	X mpk; p.o.	8
G7	Test Formulation-1	XX mpk; p.o.	8

# 5 extra animals will be taken extra due to variability in the disease development and possibilities of animal mortalities

 

4.0 METHOD:

·       Animals will be acclimatized for 7 days prior to main experiment and maintained all standard condition as per CPCSEA guidelines.

·       Animals will be randomly divided into seven groups containing eight animals in each.

·       To induce ulcer the overnight fasted animals will be received single dose of indomethacin orally at the dose of 60mg/kg.

·       Group of animals G1 will be served as normal control (without ulceration) and administered with 0.25% sodium CMC at 10ml/kg.

·       Group of animals G2 will be served as ulcerated control and administered with 0.25% sodium CMC at 10ml/kg.

·       Group of animals G3 will be served as reference drug and administered with omeprazole at the dose of 30mg/kg p.o.

·       Similarly, group of animals G4 to G7 will be administered with test compound/test sample at different dose level.

·       The animals will be administered with vehicle or test compound or reference drug for 21 days prior to the indomethacin administration (prior to ulceration).

·       4 h post ulcer induction, the animals will be humanely sacrificed by high dose of thiopental sodium.

·       The stomach opened along greater curvature and gastric content will be drained into a centrifuge tube.

·       5ml of distilled water will be added and the resultant solution will be centrifuged at 3000 rpm for 10 min. The supernatant will be separated and stored for biochemical analyses.

·       The cleaned stomachs will be preserved in 0.1 M phosphate saline buffer (1:4 (w/v), pH 7.4) prior to macroscopic examination and homogenization.

·       Cleaned stomachs will be scored using dissecting microscope with square-grid eyepiece based on grading on a 0–5 scale (depicting severity of vascular congestions and lesions/hemorrhagic erosions).

·       Mean ulcer score for each animal will be expressed as ulcer index (U.I) and the percentage of inhibition against ulceration will be determined using the expressions:

 

U.I. = [Ulcerated area/total stomach area] × 100.

 

%Ulcer inhibition = [U.I. in control − U.I. in test] × 100/U.I. in control

 

5.0 End Point Parameter:

·       Ulcer Index

·       % Ulcer inhibition

·       Histopathology of stomach tissue

·       pH of GI content

·       Superoxide dismutase (SOD) and malondialdehyde (MDA) (In stomach homogenate)

 

 

6.0  REFERENCE(S):

 

6.1 Saheed Sabiu, Taofeeq Garuba, Taofik Olatunde Sunmonu, AbdulHakeem O. Sulyman & Nurain O. Ismail (2016) Indomethacin-induced gastric ulceration in rats: Ameliorative roles of Spondiasmombin and Ficusexasperata, Pharmaceutical Biology, 54:1, 180-186, DOI: 10.3109/13880209.2015.1029050

6.2 Johnley I. I. R, Somasundaram G, Salwe K. J, Manimekalai K. Anti Ulcerogenic and Anti-Oxidant Activity of Alpinia Galanga Rhizomes Aqueous Extract in Indomethacin Induced Gastric Mucosal Damage in Wistar Albino Rats. Biomed Pharmacol J 2020;13(1).

Rupali V. Jadhav, V. K. Redasani, Shankar B. Kalbhare, Karishma Yadav, Aryan Langeh, Amuruta Tidke. Evaluation of anti-ulcer activity of 4-hydrooxy benzalydehide against NSAIDs induced ulcers in rats. International Journal of Research in Medical Sciences Jadhav RV et al. Int J Res Med Sci. 2021 May;9(5):1412-1416

                                     END OF DOCUMENT

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6.STUDY PROTOCOL: EVALUATION OF ANTI-ULCER ACTIVITY OF NATURAL PROBIOTIC FORMULATION USING EXPERIMENTAL ANIMALS

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