Acute and subchronic oral toxicity studies of majun brahmi and itrifal muqawwi dimagh (traditional unani formulations) in rats

Background: Majun Brahmi (MB) and Itrifal Muqawwi Dimagh (IMD) are polyherbal Unani formulations traditionally used for the treatment of mild cognitive impairment and memory enhancement. Although they are widely used, there is no particular scientific evidence regarding the toxicity of these medicines. Objective: The present study was undertaken to evaluate the safety of MB and IMD polyherbal Unani formulation. Materials and Methods: Wistar albino rats of both genders were treated with three doses of each drug - MB and IMD, i.e., 513.88, 1027.77, and 2055.54 mg/kg body weight (bwt) orally for 14 days for acute and 90 days for subchronic oral toxicity studies. At the end of the study, bwt gain, hematology, clinical biochemistry, and histopathological examination were performed. Although no significant changes in biochemical parameters occurred at the highest dose, mild damage to the liver, kidney, and spleen was observed. Results: At the lowest dose and at the dose of 1027.77 mg/kg bwt (therapeutic effective dose [TED]) of both the drugs, no abnormalities were observed in the biochemical and hematological parameters as well as histopathological findings. Conclusion: None of the rats exhibited apparent toxicity or mortality. The results of the present study provide evidence that both the formulations are not toxic at the TED dose and hence are clinically safe.