Acute and subacute toxicity of an antidiabetic Siddha herbal formulation

The management of diabetes is considered a global problem. FS002, a polyherbal Siddha formulation intended to be used for diabetic patients, has been screened for toxic effect. For sub-acute toxicity studies, different doses of FS002 were administered orally to rats once daily for 30 days. Animals were observed for physiological and behavioral responses, mortality, food, water intake and body weight changes. Hematological evaluation was performed weekly. Biochemical studies were done on liver and serum enzyme levels. No mortality was observed up to 4 gm/kg of FS002 in acute studies. Daily administration of as high as 2 gm/kg of FS002 did not result in mortality or changes in behaviour, body weight, organ weight, histology, serum and liver biochemistry. The dose required to produce significant antidiabetic activity in rats, 0.2-0.5 gm/Kg, is much lower than doses used in present study. For a chronic disease like diabetes such doses may be safe for daily administration without causing any serious side effects.