Toxicity assessment of a novel polyherbal formulation with promising nephroprotective effects

Safety assessment of novel herbal formulations is essential to ensure in vivo safety, particularly in developing therapeutic drug leads. The present study assessed the acute and subacute toxicity effects of a chemically standardized polyherbal formulation derived from the aqueous refluxed extract of Abelmoschus moschatus Medik. (Family: Malvaceae; leaves) and Asparagus falcatus L. (family: Asparagaceae; leaves) and Barleria prionitis L. (family: Acanthaceae; whole plant) in healthy Wistar rats. The dried herbal materials were mixed at a ratio of 1:1:1 (w/w) and subjected to refluxing for four hours. The resulting aqueous extract in the freeze-dried form was used at doses of 200 mg/kg bw, 400 mg/kg bw, and 600 mg/kg bw in acute and sub-acute toxicity studies in healthy Wistar albino rats, following OECD guidelines. A comprehensive panel of hematological parameters, and biochemical parameters including fasting serum glucose, lipid profile parameters, and kidney and liver function parameters were estimated. Assessment of histology was carried out in vital organs on H and E-stained sections. No treatment-related behavioral changes, toxicity, or mortality were observed in male and female Wistar albino rats throughout the study period of 14 days during acute toxicity assessment. In the sub-acute toxicity study, the biochemical and hematological parameters were found within the physiological limits of the species, and the normal tissue architecture was observed in vital organs based on the H and E-stained sections of the heart, liver, small intestine, spleen, and kidney tissues. A significant change was observed with the activity of alanine aminotransferase in female rats following sub-acute oral administration of the 200 mg/kg bw dose of the polyherbal formulation, however, the values were within the physiological limits for the species. The findings revealed that the aqueous polyherbal formulation derived from A. moschatus, A. falcatus , and B. prionitis is safe in vivo according to the OECD guidelines for the testing of drugs.