A Pilot study to assess the safety of Rasamanikya (An Arsenical formulation) in healthy volunteers

Backround: Ayurvedic medicines are alleged to be one of the sources of heavy metal toxicity. Hence, it has become necessary to prove their safety on the scientific base with appropriate evidences. Methodology: A pilot study was conducted after the preclinical safety evaluation of Rasamanikya, an arsenical formulation in Ayurveda. Ten healthy volunteers were administered Rasamanikya 125mg twice a day for fifteen consecutive days. Heavy metal estimation in blood was conducted before intervention and at the end of intervention. Student’s paired t test was applied at 5% level of significance. Result: Out of nine heavy metals, only Arsenic in blood was increased significantly in all the ten volunteers without any signs of clinical toxicity. Conclusion: The drug was found to be safe as evidenced in the previous preclinical study.