Diabetes Mellitus is a common metabolic disorder seen in all age groups. Gandhaga chooranam (GC) has been employed as a traditional remedy for Diabetes mellitus which is a herbo mineral formulation. As a mandate, steps were taken to evaluate safety profile of GC in rats following OECD guidelines. Acute toxicity studies, were done on female wistar albino rats as per OECD guidelines 423 and 28 days repeated oral toxicity study was done on wistar albino rats of both sex as per OECD guidelines 407.Acute oral toxicity study of GC revealed no mortality at the dosage of 2000 mg/kg body weight and the median lethal dosage of GC is estimated to be above 2000 mg/kg body weight. Repeated oral toxicity study of GC does not exhibit mortality at the high dosage of 400 mg/kg body weight given up to the period of 56 days including 28 days of drug administered. At the end of 28 days no specific changes are observed in hematological, hepatic, renal and other biochemical parameters. No gross morphological and histological changes were observed in the organs. The GC was found to be safe in animals. No toxic effect was observed upto 400 mg/kg of Gandhaga chooranam in acute and sub-acute toxicity studies. The above studies recommend that GC is a safest drug under intended human adult dosage (1000 mg) as illustrated in the literature.
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