Abstract

Rasamanikya (an arsenical formulation of Ayurveda) contains Haratala (arsenic trisulphide) as an integral component. Concerns are being raised on such Ayurveda formulations with heavy metals in their composition for safety aspects. Though, these have been used safely in Ayurvedic clinical practice since ages without any noticeable untoward effects; there is need to generate scientific evidence that these are safe and nontoxic. In the present study, safety profile of Rasamanikya prepared from Kushmanda swarasa shodhita haratala (arsenic trisulphide processed in juice of Benincasa hispida) was evaluated through acute and chronic toxicity studies. In acute toxicity, Rasamanikya was administered at a maximal dose of 2000 mg/kg to overnight fasted rats and observed closely for behavioral changes, signs of toxicity and mortality if any, continuously for the first six hours and thereafter periodically up to 14 days. In the chronic toxicity evaluation, the drug was administered daily at the doses of 22.5, 112.5 and 225 mg/kg along with honey and ghee as an adjuvant to rats for 90 days followed by a 30-day recovery period. Animals were sacrificed on the 91st day and hematological, serum biochemical parameters and histopathology of organs were studied. In acute toxicity, Rasamanikya at the dose of 2000 mg/kg did not produced any observable toxic effects or mortality. Safety of Rasamanikya at therapeutic and five-fold therapeutic dose level has been revealed in the chronic toxicity study. Mild to moderate pathological changes on different haematological, serum biochemical and cytoarchitecture of different organs were observed at ten-fold therapeutic dose level. Based on these observations, it can be concluded that Rasamanikya is safe at therapeutic dose levels when used judiciously along with specified adjuvants.