Protocol
1.0 INTRODUCTION:
Inflammation is a local response of living mammalian tissues to the injury. It is a body defense reaction in order to eliminate or limit the spread of injurious agents. There are various components to an inflammatory reaction that can contribute to the associated symptoms and tissue injury. Chronic inflammation can cause persistent tissue damage and unwarranted pain due to the release of inflammatory mediators, including bradykinin, prostaglandins, and various cytokines, released locally during tissue damage or by inflammatory cells. Inflammatory pain is characterized by increased activity of primary afferent nerves (nociceptors), resulting in spontaneous pain, hyperalgesia, and allodynia.
2.0 TEST SYSTEM DETAILS:
Species : Rattus norvegicus
Strain : Wistar; Sprague dawley
Age : 8-10 weeks
Body Wight : 150-200 g
Sex : Male or Female
No. of animals : 8 /Group
3.0 ALLOCATION OF GROUPS:
|
Groups |
Treatment |
Dose; ROA |
No. of Animals |
|
G1 |
Normal
Control |
Normal
saline or 0.25% Na-CMC |
8 |
|
G2 |
CFA
Control |
Normal
saline or 0.25% Na-CMC |
8 |
|
G3 |
Reference
Drug- Dexamethasone |
5
mpk; p.o. |
8 |
|
G4 |
Test Sample-1 |
X
mpk; p.o. |
8 |
|
G5 |
Test Sample -2 |
XX
mpk; p.o. |
8 |
*The dose and ROA (Routes of administration) will be decided based on the type of reference drug
4.0 METHODOLOGY:
· The study protocol (Form B) shall be approved from the IAEC before commencing the experiment.
· Animals shall be procured from the CPCSEA authorized vendor.
· Animals shall be quarantined for 1 week as per the in house SOP.
· Healthy animals will be selected, randomized based on body weight and divided into five different groups consisting of 8 animals each.
· To induce inflammation the rat will be injected subcutaneously 50 µL of Complete Freund’s adjuvant (CFA) into the dorsal surface of the left hind paw.
· The inflammation will be measure on weekly basis using plethysmometer after CFA injection.
· The treatment schedule will be as follows:
· Group G1 animal will be treated as normal control and treated with normal saline or Na- CMC.
· Animals of group G2 will be treated as CFA control and administered with normal saline or Na- CMC.
· Animals of group G3 will be treated orally with dexamethasone at the dose of 5mg/kg.
· Group G4 and G5 animals will be treated with test compound at different dose levels.
· All drug or vehicle and test compound will be administered to animals after CFA injection (Day 0) and continued for 28 days.
· At the end of study the animals will be sacrificed and the blood will be collected from retro orbital plexus.
· The blood will be centrifuged at 4000g for 10min and serum will be separated and stored for cytokines estimation.
5.0 END POINT PARAMETER(S):
· % Anti-inflammatory activity (% Inhibition)
· Cytokines estimation IL-beta, TNF-alpha
6.0 REFERENCE(S):
6.1 Afsar SK, et al., Assessment of anti-inflammatory activity of Artemisia vulgaris leaves by cotton pellet granuloma method in Wistar albino rats, Journal of Pharmacy Research (2013), http://dx.doi.org/10.1016/ j.jopr.2013.04.056.
6.2 P. C. Lalawmpuiia*, c. Malsawmtluangia, r. Vanlalruataa, b. B. Kakoti. Evaluation of anti-inflammatory activity of helicia nilagirica bedd on cotton pellet-induced granuloma in rats. Int j pharm pharm sci, vol 8, issue 7, 455-456.
6.3 Kalpesh R. Patil, Umesh B. Mahajan, Banappa S. Unger, Sameer N. Goyal, Sateesh Belemkar, Sanjay J. Surana, Shreesh Ojha, and Chandragouda R. Patil. Animal Models of Inflammation for Screening of Anti-inflammatory Drugs: Implications for the Discovery and Development of Phytopharmaceuticals. Int. J. Mol. Sci. 2019, 20, 4367; doi:10.3390/ijms20184367
6.4 Tapas Kumar Sur, Biswajit Auddy, Susil Kumar Mitra, Dipak Kumar Sarkar, and Dipankar Bhattacharyya. Anti-inflammatory Activity of Detoxified Bacterial Strains in Wistar Rats. Natural Product Sciences. Vol. 16, No. 3, 2010 161
END OF THE DOCUMENTS
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