Maintenance of weight loss usually requires a long term therapy of a drug with repeated doses. Therefore, present study was aimed to evaluate the safety of fattolin, a polyherbal formulation using acute and sub-acute oral toxicity studies in laboratory rats. In acute oral toxicity study, three albino wistar female rats received a suspension of fattolin orally with an initial dose of 2000 mg/kg body weight and observed for mortality and behavioural changes. Eighteen albino wistar female rats were used in sub-acute oral toxicity study and were equally divided into three groups (n = 6). Group I received a vehicle (10 ml/kg), whereas Group II and III received fattolin orally 200 and 400 mg/kg, respectively for 28 days. The rats were observed twice daily for morbidity and mortality. Further the body weight, organ weight, biochemical, haematological estimations and histological studies were performed to assess the safety of fattolin. Fattolin at a dose of 2000 mg/kg did not produce any mortality and clinical sign of toxicity. Further no toxicity signs or death were recorded during the 28 days of treatment. However, the treatment with fattolin (400 mg/kg) showed significant decrease in body weight but these effect could not produce significant changes in organ to body weight ratio. Further biochemical and haematological parameters did not show significant alteration as compared to control rats. The histopathological studies showed no structural alteration in fattolin treated rats. In conclusion, the oral administration of fattolin was found safe and can be used for long term treatment of obesity.
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