EVALUATION OF TEST SAMPLE FOR INFLAMMATORY PAIN USING CARRAGEENAN INDUCED INFLAMMATORY PAIN IN EXPERIMENTAL ANIMALS

                                                                   STUDY PROTOCOL

EVALUATION OF TEST SAMPLE FOR INFLAMMATORY PAIN USING CARRAGEENAN INDUCED INFLAMMATORY PAIN IN EXPERIMENTAL ANIMALS

1.0  INTRODUCTION:

Pain is an essential adaptive response for the protection of the integrity of organism and arises in response to actual or potential tissue-damaging stimuli. In some instances, the component of pain persists despite the resolution of the inflammatory injury state. There are various components to an inflammatory pain reaction that can contribute to the associated symptoms and tissue injury. Chronic inflammation pain 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             : Mus musculus

Strain                : Swiss; CD1; Blab/c

Age                   : 8-10 weeks

Body Wight        : 25-30 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	Disease Control	Normal saline or 0.25% Na-CMC	8
G3	Reference Drug- Dexamethasone	1 mpk; p.o.	8
G4	Plant Extract-1	X mpk; p.o.	8
G5	Plant Extract-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 inflammatory pain the mice will be injected 20 µL of 1% carrageenan into the plantar surface of the right hind paw.

·       Pain behavior assay Hot Plate test and Rota rod test will be carried out blindly before drug and then at intervals of 30 min, 60 min, 90 min, 120 min and 150 min after carrageenan injection.

·       Each animal will be tested three times for single recording with a 5 seconds interval between the two measurements to nullify the previous effect.

·       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 disease control and administered with normal saline or Na- CMC.

·       Animals of group G3 will be treated orally with dexamethasone at the dose of 1mg/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 1h before carrageenan challenge.

5.0 END POINT PARAMETER(S):

·       Body Weight

·       Clinical observation

·       Hot plate test

·       Rota rod test

6.0  REFERENCE(S):

Malik Z, Abbas M, Al Kury LT, Shah FA, Alam M, Khan AU, Nadeem H, Alghamdi S, Sahibzada MUK, Li S. Thiazolidine Derivatives Attenuate Carrageenan-Induced Inflammatory Pain in Mice. Drug Des Devel Ther. 2021;15:369-384
https://doi.org/10.2147/DDDT.S281559.

                                     END OF DOCUMENT

You may like to read theses links:   

1. List of All SOPs and Documents for In-vivo Laboratory

2. List of All SOPs and Documents for Study Protocol

3. List of Pharmacological Study Models with details about disease Inducing agent, Standard or Reference Drug and related parameters.

4.List of OECD Guidelines or Toxicological Studies

5.List of Pharmacopeial Test or Quality Control Test or Batch Testing Parameters (In-vivo)

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