Toxicity Profiling of Siddha Formulation Sarakondrai Chooranam by Acute and Repeated Oral dose Toxicity Studies in Wistar Rats

Abstract

Toxicity Studies become an integral part of drug discovery and development process which involves different models, ranging from test tube experiments to cell cultures, animals, healthy human subjects. Although herbal medicine as the most common form of alternative medicine are widely used for treatment of various diseases all over the world now as per the regulatory guidelines it become mandatory to evaluate the short term and long term toxicities studies in rodents to establish the safety before utilizing the same for the clinical aspect. In Siddha system of traditional medicine it was clearly mentioned in detail about the toxic effects of various herbs and mineral components and also detailed in depth about the procedures for purification and detoxification of the same. But still now there is very limited documentary literatures available on the toxicity profiling of most of the Siddha preparation, hence the main aim of the present investigation is to carry out the systematic acute and repeated oral dose toxicity studies of the Siddha formulation Sarakondrai Chooranam (SKC) on rodents and to establish the safety of the drug. In short term acute toxicity study the drug SKC was administered in single dose of 2000 / kg b.w (p.o).Potential drug toxicity related to C.N.S, A.N.S and C.V.S were observed up to 14 days. In sub-acute repeated oral dose toxicity study the formulation SKC was administered at two dose level such as low and high dose of 200 and 400 mg / kg b.w (p.o) for four weeks. Results obtained from the acute and sub-acute study reveals that the Siddha formulation SKC doesn’t reveal any significant change in body weight, behavior and mortality in treated rats and no sign of toxicity was registered throughout the study. Further it was observed that SKC at both the dose level did not modify the weight index, food and water intake in treated animals. There is no significant change in haematological, bio-chemical and histopathological observation of animals treated with SKC at both the dose level of 200 and 400 mg / kg b.w (p.o) when compare to control group animals. From the evidence based results of the present investigation it was concluded that the Siddha preparation SKC has wide safety margin in tested rodents and further long term usage of this formulation will be considerably safe for the ailment of various disease in humans.