EVALUATION OF PROTECTIVE EFFECT OF TEST SAMPLE STREPTOZOTOCIN INDUCED DIABETIC NEUROPATHY PAIN MODEL IN EXPERIMENTAL RAT

                                                                     STUDY PROTOCOL

EVALUATION OF PROTECTIVE EFFECT OF TEST SAMPLE STREPTOZOTOCIN-INDUCED DIABETIC NEUROPATHY PAIN MODEL IN EXPERIMENTAL RAT

1.0  INTRODUCTION:

Chemotherapeutic agents can cause toxic effects on peripheral nerves. Severity may range from loss of sensory function and mild paresthesias to neuropathic pain, severe ataxia, and weakness leading to pronounced disability. In tissue culture, Paclitaxel promotes the formation of abnormal bundles of microtubules within the cytoplasm, leading to the disruption of normal cell function and proliferation. Microtubules are important for the development and maintenance of neurons. Microtubule elongation contributes toward the growth of neurites through interactions with the growth cone and they are the major participating elements mediating axonal transport in the neuron.

 

2.0  TEST SYSTEM DETAILS:

Species             : Rattus norvegicus (Rat)

Strain                : Wistar or Sprague Dawley

Age                   : 8-10 weeks

Body Wight        : 160-180 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- Gabapentin	75 mpk; i.p.	8
G4	Plant Extract-1	X mpk; p.o.	8
G5	Plant Extract-2	XX mpk; p.o.	8
G6	Plant Extract-3	XXX 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 by the IAEC before commencing the experiment.

· Animals shall be procured from the CCSEA-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.

· Induction of Diabetes

· Diabetes will be induced in Wistar rats by a single intraperitoneal injection of streptozotocin in cold sodium citrate buffer 0.1 M, pH 4.5 at the dose of 50 mg/kg.

· The rats will be free access to 5% glucose water and basal diet ad libitum during the next 24 hours.

· Blood samples will be obtained from retroorbital plexus in STZ-injected animals at 72 h, after an overnight fast.

· The rats having blood glucose levels (fasting) above 250 mg/dl will be used for the study.

· The diabetic animals will be allowed free access to water, and a pellet diet, and will be maintained at room temperature in plastic cages.

· Diabetic rats will be randomized based on their blood glucose level into six groups of 8 animals each.

· Treatment and assessment of neuropathy pain:

· Group G1 animals 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.

· Group G4, G5, and G6 will be treated with test compounds at different dose levels.

· All the animals will be administered with a vehicle test sample or reference drug on day 0 (after randomization) and continued throughout the experiment.

· The behavioral tests mechanical allodynia, motor coordination, cold hypersensitivity, and thermal hyperalgesia will be conducted at Day, 0, 7, 14, 21, 28, 35, 42 (after randomization).

5.0 END POINT PARAMETER(S):

·       Body Weight

·       Feed water consumption

·       Mechanical allodynia

·       Thermal Hyperalgesia

·       Cold hypersensitivity

·       Serum cytokines - TNF-α and IL-1β

6.0  REFERENCE(S):

6.1 Gowhar Ali & Fazal Subhan & Muzaffar Abbas & Jehan Zeb & Muhammad Shahid & Robert D. E. Sewell. A streptozotocin-induced diabetic neuropathic pain model for static or dynamic mechanical allodynia and vulvodynia: validation using topical and systemic gabapentin. Arch Pharmacol (2015) 388:1129–1140.
6.2 Seigo Usuki, Yukihiko Ito, Keiko Morikawa, Mitsuo Kise, Toshio Ariga, Michael Rivne2 and Robert K Yu. Effect of pre-germinated brown rice intake on diabetic neuropathy in streptozotocin-induced diabetic rats. Nutrition & Metabolism 2007, 4:25.
6.3 Davood Nasiry, Ali Reza khalatbary, Hassan Ahmadvand, Fereshteh Talebpour Amiri, and Esmaeil Akbari. Protective effects of methanolic extract of Juglans regia L. leaf on streptozotocin-induced diabetic peripheral neuropathy in rats. BMC Complementary and Alternative Medicine (2017) 17:476 DOI 10.1186/s12906-017-1983-x.
6.4 https://deepblue.lib.umich.edu/bitstream/handle/2027.42/153112/cpns0918.pdf?sequence=1.
6.5 Hajar Oghbaei, Mohammad Reza Alipour, Gisou Mohaddes, Gholam Reza Hamidian, Rana Keyhanmanesh. Evaluation of the ameliorative effect of sodium nitrate in an experimental model of streptozotocin-induced diabetic neuropathy in male rats. ENDOCRINE REGULATIONS, Vol. 53, No. 1, 14–25, 2019.
6.6 Magdalena Zychowska, Ewelina Rojewska, Barbara Przewlocka, Joanna Mika. Mechanisms and pharmacology of diabetic neuropathy – experimental and clinical studies. Pharmacological Reports 2013, 65, 16011610.

6.7 Source Research Needs YouTube Channel: Diabetes-Induced Erectile Dysfunction Video  

                                     END OF DOCUMENT

You may like to read these 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 Tests Quality Control Tests or Batch Testing Parameters (In-vivo)

6. EVALUATION OF PROTECTIVE EFFECT OF TEST SAMPLE IN SURGICALLY INDUCED NEUROPATHY PAIN USING CHRONIC CONSTRUCTIVE INJURY (CCI) MODEL IN EXPERIMENTAL RAT

7. EVALUATION OF PROTECTIVE EFFECT OF TEST SAMPLE IN PACLITAXEL-INDUCED NEUROPATHY PAIN MODEL IN EXPERIMENTAL RAT

8.EVALUATION OF HYPOGLYCEMIC POTENTIAL OF PLANT EXTRACT(S) USING NORMAL AND GLUCOSE INDUCED HYPERGYCEMIC RATS

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