Abstract
Sudarshana powder (SP) is an Ayurvedic preparation, which contains 53 herbal ingredients along with 50% of Andrographis paniculata and is clinically used with bees honey. This study was aimed to determine the safety profile of the SP, and its novel preparation Sudarshana suspension (SS) on male Wistar rats and tolerance studies were conducted for healthy adult volunteers. Acute and subacute toxicity studies of the SS and hot water extract of SP were assessed in Wistar rats by observing the general behavior, analyzing biochemical and haematological parameters, and pathological observation. Healthy consented adult volunteers (n = 35) of either sex were selected, and tolerance studies of SS were tested by measuring the biochemical and haematological parameters. There were no significant (p > 0.05) changes observed in the treated animals with SS and hot water extract of SP compared with control in body weights, food intake, and water consumption as well as the biochemical and haematological parameters. Histopathological studies revealed no significant (p > 0.05) changes in the liver, heart, and kidney tissues. The experimental results suggest that novel formulation SS was potentially safe for chronic administration in rats, and no significant differences (p > 0.05) were observed in tested parameters on day 3 and day 8 when compared to the day 0 (baseline) values in healthy volunteers. Healthy volunteers did not report any adverse effects or any other complications during the treatment period and the follow-up period. Therefore, it can be concluded that the novel preparation Sudarshana suspension does not cause any significant toxic effects on the blood parameters in animal and human models.