Toxicity studies for antidiabetic herbal formulation: a crude mixture (1:1:1) of Stevia rebaudiana, Andographis paniculata, and Tinospora cordifolia

Present study, evaluates „Acute toxicity“ and „Genotoxicity“ [1] of polyherbal antidiabetic formulation [2]. A „14 Days Dose Range Finding Study“ and „in vivo Micronucleus Test“ was also carried out, in rats. For „Acute toxicity study“, formulation was administered to the rats, orally (1000 and 2000mg/kg b.w), observed as per OECD guidelines, no toxic symptoms were observed. In a „14 Days Dose Range Finding Study“; the drug was administered orally at three different doses: 250, 500 and 750mg/kg b.w, once daily for 14 days. Various hematological and biochemical parameters: Glucose, Urea, etc, were measured. Animals were sacrificed on 15^th day. Different organs (liver, kidney and heart, etc.) were processed for histopathological study. The bone marrow smears were also evaluated for micronucleus induction potential. Test substance did not produce any adverse pathological effect or its related changes in either sex, at the high dose (750mg/kg) level. Maximum dose of 750mg/kg b.w was well tolerated, after 14 days continues administration. Bone marrow smear evaluation reveals that, MicroNucleated PolyChromatic Erythrocyte, MicroNucleated NormoChromatic Erythrocyte and PolyChromatic Erythrocyte/NormoChromatic Erythrocyte in high dose group animals, were comparable to control group animals. Results were analyzed, using Student's 't' test and one way ANOVA .This formulation was found to be non toxic (at acute and genotoxic level) up to 750mg/kg b.w dose level.

References: [1] Matsui, M. et al. (1996) Mutagenesis 11:573–579.

[2] Chandra, S.J. et al. (2007)J. Health Sci. 53:245–249.