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180-Days repeated dose oral toxicity study of polyherbal unani formulation: Jawarish Shahi

Mohammad Ahmed Khan, Mohd Urooj, Thejaswini G, Syed Shoeb Ahmed, Munawwar Husain Kazmi, Gulam Mohammed Husain*

Background Jawarish Shahi (JS) is a compound Unani Pharmacopoeial formulation indicated for Khafqan (Palpitation), Nafkhe Shikam (Flatulence) and Waswas (Insanity; false perception and hallucinations). However, JS has not been evaluated for its safety. Therefore, present study was conducted to evaluated long term toxicity / safety of this Unani formulation in India during the year 2016-17. Objective The following study was carried out to study the 180 days repeated dose toxicity of JS in SD rats. Methods Study was carried out on SD rats of both sexes. Animals were divided into various groups (n=15). JS was orally administered at a limit dose of 2000 mg/kg bw/day for 180 days. After completion of 180 days blood samples were collected for haematological and biochemical analysis and animals were sacrificed and organs were harvested for weight determination and histopathological evaluation was carried out. Results Animals in groups treated with JS did not show any abnormal behaviour or clinical signs indicative of systemic toxicity based on functional observation parameters observed throughout study duration. There was no toxicologically significant alteration observed in relative organ weights, haematological and biochemical parameters of control and JS treated rats of either sex. The findings were further corroborated by histopathological studies. Conclusion No toxicologically significant changes were observed with respect to clinical signs of toxicity, body weight, feed intake, haematology, biochemistry profile, gross necropsy and histopathology in JS treated rats as compared to control group. It may be concluded based on above observations that No Observed Adverse Effect Level (NOAEL) of JS in SD rats is >2000 mg/kg bw.