EVALUATION OF THE EFFICACY OF HERBAL FORMULATIONS IN RAT MODEL OF CYCLOPHOSPHAMIDE-INDUCED THROMBOCYTOPENIA

EVALUATION OF THE EFFICACY OF HERBAL FORMULATIONS IN RAT MODEL OF CYCLOPHOSPHAMIDE-INDUCED THROMBOCYTOPENIA

1.0 TEST SYSTEM DETAILS:

Species : Rattus norvegicus (Rat)

Strain : Sprague Dawley or Wistar

Age : 7-8 weeks

Sex : Male

No. of animals : 8 /Group

Total animals : 40

2.0 TEST ARTICLES DETAILS

Plant based herbal formulation.

3.0 ALLOCATION OF GROUPS:

Group No.	Group Description	Disease-Induction agent administered	Treatment administered	No. of Animals	Dose Volume and Route
G1	Normal Control	Sterile water × 3 consecutive days by intraperitoneal route (i.p.)	0.5% MC, p.o., q.d.	8	10 ml/kg, p.o.
G2	Disease Control	Cyclophosphamide × 3 consecutive days by intraperitoneal route	0.5% MC, p.o., q.d.	8
G3	Treated with a low dose of Test Compound		X1 mg/kg, q.d..  in 0.5% MC	8
G4	Treated with an intermediate dose of Test Compound		X2 mg/kg,    q.d.. in 0.5% MC	8
G5	Treated with a high-dose Test Compound		X3 mg/kg,   q.d.. in 0.5% MC	8

Abbreviations: MC-Methyl Cellulose, p.o.-per os. q.d.: quaque die; bid: bis in die. X1, X2,  and X3 are defined as the incremental doses of Herbal formulations. The dose range will be from 10 mg/kg to 1000 mg/kg, q.d.

4.0 METHOD:

· Healthy animals will be selected, randomized based on body weight, and allocated into 10, different groups consisting of 8 animals each.

· Animals of Group G1 will serve as normal control and will be administered 0.5% MC, p.o., b.i.d.

· Disease control animals (assigned to group G2) will receive 0.5% MC, p.o., b.i.d.

· Animals of group G3-G5 will be treated with the Test compound, at different dose levels ranging from 10-1000 mg/kg, b.i.d.

· Normal control group (G1) will be administered sterile water by intraperitoneal route, for three consecutive days. Animals allocated to G2 – G5 will be administered cyclophosphamide (50, 25, 25 mg/kg) for three consecutive days respectively.

· Compound administration will be initiated 14 days prior to cyclophosphamide injection and for another 15 days post-cyclophosphamide injection.

· Blood will be withdrawn from the retro-orbital sinus of the rats under transient isoflurane anesthesia on day 0 and days 3, 11, and day 15 post-cyclophosphamide injection

· On Day 15 the animals will be euthanized by an overdose of thiopentone (150 mg/kg, i.p.). Before the animal dies, blood will be collected from the retro-orbital plexus for estimation of complete blood counts, oxidative stress parameters, and cytokines. Subsequently, after the animal dies the femur, liver, and spleen will be harvested for the ensuing histopathological analysis.

5.0 PARAMETERS TO BE EVALUATED:

· Body weight twice a week.

· Spleen and liver weights.

· Complete blood count (On day 0 and days 3, 7, 11, and 15 post-cyclophosphamide injections)

· Oxidative stress parameters in the serum - Malondialdehyde, oxidized and reduced glutathione along with their ratio, total nitrite content, activities of myeloperoxidase, superoxide dismutase, catalase, and glutathione peroxidase.

· Histology of the femoral bone marrow, liver, and spleen subsequent to hematoxylin and eosin staining.

6.0 REFERENCE(S):

1. Anjum, V., Arora, P., Ansari, S. H., Najmi, A. K. & Ahmad, S. Antithrombocytopenic and immunomodulatory potential of metabolically characterized aqueous extract of Carica papaya leaves. Pharm. Biol. 55, 2043–2056 (2017).

2. Khazaei, F., Ghanbari, E. & Khazaei, M. Protective effect of royal jelly against cyclophosphamide-induced thrombocytopenia and spleen and bone marrow damages in rats. Cell J. 22, 302–309 (2020).

3. Ramadan, G., El-Beih, N. M. & Zahra, M. M. Egyptian sweet marjoram leaves protect against genotoxicity, immunosuppression, and other complications induced by cyclophosphamide in albino rats. Br. J. Nutr. 108, 1059–1068 (2012).

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 agents, Standard or Reference drugs, 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. Animal  Facility Design - Small Laboratory Animals (Rat, Mice, Rabbit, Guinea Pig)

 

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