European Journal of Biomedical and Pharmaceutical Sciences

PRECLINICAL SAFETY EVALUATION OF SIDDHA FORMULATION KEELVAYU NIVARANA CHOORANAM BY ACUTE AND SUB-ACUTE TOXICITY STUDIES IN WISTAR RATS

T. Giftillda Selva Elsee*, M.D. Saravana Devi, K. Rajammadevi Sorubarani and V. Velpandian

ABSTRACT

Toxicity assessment is a major problem in drug and environmental chemical development. This has been well documented in the drug industry where poor preclinical and clinical safety assessment correlations. Toxicity bioassays or animal tests are important components of human toxicity assessment, but rarely address specific chemical pathways of toxicity. Thus, there is a critical need for bioanalytical platforms to establish the chemistry of metabolic toxicity pathways to augment traditional bioassays. Siddha systems of medicine have been used for thousands of years in worldwide traditional medicines for their potential health benefits. Although they are generally presumed safe unless a significant risk has been identified in humans, increasing number of case reports notify acute or chronic intoxications resulting from their use. Keelvayu Nivarana Chooranam (KVNC) is a poly herbal preparation which comprises of certain biologically significant herbs like Hemidesmus indicus, Smilax chinensis, Withania somnifera and Alpinia officinarum. The main aim of the present investigation is to establish the safety profile of the test drug KVNC in rodent model acute and sub-acute oral toxicities in accordance with OECD regulatory guidelines. Acute toxicity testing is carried out to determine the effect of a single dose on a particular animal species. In the present study acute toxicity sere been carried out by single oral administration of 2000mg/kg. In the sub-acute study, repeated doses (20,100 and 200mg/kg) of the test drug KVNC were administered for 28 days followed by this biochemical and hematological parameters were evaluated. Results of the study have revealed that there was no sign of toxicity and no mortality after single and repeated administration of the test drug KVNC in experimental animals. A normal haematological and serological profile of KVNC treated groups in sub-acute toxicity study further justified the non-toxic nature of the formulation. There is no significant changes were observe in the body weight, ,food intake, water intake, relative organ weight and also in histological analysis of the samples retrieved from the drug treated rats. Since there was no reduction in body and relative organ weights of the treated animals at any of the tested dose it was concluded that the siddha drug KVNC is nontoxic and has wide safety margin.

Keywords: Toxicity assessment, OECD guidelines, Siddha system, Keelvayu Nivarana Chooranam, Hematological profile, serology.