Abstract

Background The test drug Changan Ilai Kudineer composed of of chief ingredient Azima tetracantha which is referenced from Gunapadam Mooligai vaguppu. It has wide clinical role and majorly used to alleviate vatha related disorders. Even though it is from herbal origin, The safety profile has to be evaluated for the wellness of mankind. Objective: The objective of this study was to investigate the acute toxicity parameters of Siddha herbal formulation Changan Ilai Kudineer. Method: Acute oral toxicity is carried out as per the OECD-423 guidelines after the animal ethical clearance from Institutional Animal Ethics Committee. In the acute toxicity study female albino Mice administered single oral dose (0, 300, 2000 mg/kg) of Changan Ilai Kudineer, and observed the physical symptoms and behavioral changes for the crucial phases of the study. Results: In the acute toxicity study, no such mortality or behavioural changes were observed in the treated animals with a varied single dose of Changan Ilai Kudineer upto 2000 mg/kg. Conclusion: These results exhibit the absence of acute oral toxicity after treatment of Changan Ilai Kudineer in rats. However, further clinical studies humans are needed in order to have sufficient safety evidence for its use in humans.