Abstract

SAFETY EVALUATION OF SIDDHA FORMULATION AKIL KATTAI CHOORANAM BY ACUTE AND SUB-ACUTE TOXICITY STUDIES IN WISTAR RATS

X. Helen Sathiya*, N. Anbu, P. Parthibhan and K. Kanakavalli

ABSTRACT

According to the recent regulatory guidelines preclinical toxicity evaluation of the siddha formulations is mandatory to ascertain the possibility of adverse event in humans upon short and long term usage of the drugs. The main aim of the present research work is to evaluate the safety of the traditional siddha formulation Akil Kattai Chooranam (AKC) and to establish the toxicity profiling by acute and sub-acute toxicity studies in accordance with OECD guidelines. In short term acute toxicity study the drug AKC was administered in single doss 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 toxicity study the drug AKC was administered at two dose level such as low and 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 drug AKC doesn’t reveal any significant change in body weight, behavior and mortality in treated rats. Throughout the study period no sign of toxicity was registered. Further it was observed that AKC at both the dose level did not modify the weight index, food and water intake in treated animals. There is no significant change in hematological, biochemical and histopathological observation of animals treated with AKC at both the dose level of 200 and 400 mg / kg b.w (p.o) when compare to control group animals. From the result it was concluded that the siddha preparation AKC offers wide margin of safety in tested rodents and further long term usage of drugs will be considered as safe for the ailment of various disease.

Keywords: Siddha, Akil Kattai Chooranam, OECD, Toxicity profiling, Acute study, Sub-acute.