Acute and sub-chronic oral toxicity study of AYUSH MANAS in experimental animals

BACKGROUND: AYUSH MANAS is a coded polyherbal formulation developed for mental retardation/cognitive deficit. An experimental study has been conducted to generate scientific evidence on its safety as an integral component of drug development. METHODS: Acute and 90-day repeated-dose oral toxicity studies for the AYUSH MANAS formulation were conducted with approval of the Institutional Animal Ethics Committee. In the acute toxicity study, the test drug was administered orally at 1530 mg/kg (10 times the intended clinical dose of AYUSH MANAS) to Swiss albino mice. For the 90-day repeated-dose oral toxicity study, three different doses of the test drug (106, 530, and 1060 mg/kg) were administered to rats. Assessment of clinical signs, behavioral changes, and physical appearance was made during the course of the study, followed by hematological, biochemical, and histopathological examination at the termination of the study. RESULTS: No abnormal behavioral activity or pre-terminal deaths were observed in mice exposed to a single dose of 1530 mg/kg. In rats receiving the test drug at three different doses for 90 days, there were no pre-terminal deaths. There were no significant changes in hematological and biochemical parameters. Furthermore, histopathological analysis of major organs revealed no major lesions or treatment-related changes. CONCLUSION: The test drug AYUSH MANAS was found to be safe upon single administration at a dose of 1530 mg/kg body weight during the acute toxicity study. Furthermore, the drug was found to be nontoxic at the doses (106, 530, and 1060 mg/kg) up to 90 days of consecutive administration in rats.