Repeated-dose 90-day oral toxicity study of Hemagarbha Pottali

Abstract BACKGROUND: Hemagarbha Pottali is a metallo-mineral formulation extensively used in Ayurvedic therapeutics with no reported side effects. However, due to lack of data, safety concerns have been raised regarding Ayurveda formulations containing heavy metals such as mercury and copper as integral components. So there is a need to evaluate the safety aspects of such formulations to generate scientific evidence on their non-toxic and safe nature. METHODS: In current study, the safety profile of Hemagarbha Pottali has been evaluated through a repeated dose 90-day oral toxicity study by following OECD 408 guidelines after getting approval from the Institutional Animal Ethics Committee (IAEC/26/2020/05). The test drug was administered at TED (11.25 mg/kg), TED×5 (56.5 mg/kg), TED×10 (112.5 mg/kg), and RTED×10 (112.5 mg/kg) orally once in a day for 90 days along with honey (vehicle) and distilled water in a dose of 5 mL/kg body weight. Safety of Hemagarbha Pottali was assessed on the basis of hematological, biochemical, and histopathological changes in Wistar albino rats. RESULTS: Hemagarbha Pottali did not produced any significant changes in hematological, biochemical, and histopathological parameters at TED dose level. Mild cell infiltration with multifocal changes was observed in the kidney and ileum at TED×10 dose level; however, these changes were reversed in recovery group. CONCLUSION: Hemagarbha Pottali is safe for administration at a therapeutic dose level when administered for 90 days along with a suitable adjuvant in albino rats.