Title : Toxicity study of a general tonic (Jawarish-e-Aamla Sada) a traditional Unani formulation
Abstract:
Background:Jawarish-e-Aamla Sada is a traditional polyherbal compound Unani Pharmacopoeial formulation. It is mentioned as Muqawwi-e-Aam (General tonic), Kasir-e-Riyah (carminative), and Qabiz (constipative). It is indicated for the clinical treatment of Zof e Meda (weakness of the stomach), Zof e Kabid (weakness of the liver; Hepatitis), Zof-e-Qalb (weakness of the heart), Khafqan (palpitation), Nafkh-e-Shikam (flatulence) and Is-hal-e-Safrawi (bilious diarrhoea). No data is available regarding the toxicity of this compound Unani formulation. Therefore, present study was designed to evaluate acute and repeated dose 28-day oral toxicity study of tested formulation in rats.
Objective:To evaluate acute and repeated dose 28-day oral dose toxicity in rats.
Methods:Acute toxicity study was conducted in female Sprague dawley rat by conducting limit test at dose 2000 mg/kg bw. Repeated dose toxicity study was performed using both sexes. Animals were divided into four groups (n=05 per sex per group). Test drug was administered at the dose of 500, 1000 and 2000 mg/kg bw/day p.o. for 28 days. Control animals were administered with vehicle. Body weight and feed intake for all animals was measured weekly throughout study duration. Detailed clinical observations were made periodically to detect signs of toxicity. After completion of 28-days, blood samples were collected for haematological and biochemical analysis and animals were sacrificed, organs were harvested for weight determination and histopathological evaluation.
Results:The data of acute toxicity study showed that oral LD50 of the Jawarish-e-Aamla Sada in the female rat was estimated to be greater than 2000 mg/kg body weight. No post doses adverse effect was observed on survival of both male and female rats after oral administration of tested drug for 28 consecutive days. No significant alteration was reported in terms of haematological and biochemical parameters in both male and female rats at all tested dose level as compared to control animals except few isolated alterations which were toxicologically insignificant and lies within normal reference range. There was no significant alteration observed in body weight, feed intake and relative organ weights of control and JAS treated rats of either sex. Histology of all vital organs were found normal except lungs, liver and kidneys. Some mild to moderate histological changes were observed in lungs, liver and kidneys of both vehicle control and test drug -2000 mg/kg groups and these changes were not related to 2000 mg/kg treatment.
Conclusion:The study findings did not indicate any toxicological significant observation in terms of body weight, feed intake, behavioural pattern, haematology, clinical chemistry; organ weight in drug treated group at all tested dose level as compared to control animals. Both, vehicle control and high dose treatment group showed normal histology of all vital organs except some histological alterations in lungs, liver and kidneys and these changes were not treatment related.
