Repeated dose 28-day oral toxicity study of a polyherbal formulation containing Asparagus racemosus, Withania somnifera, Andrographis paniculata, Ocimum sanctum and Piper nigrum in wistar albino rats

Abstract

This study evaluated the repeated dose oral toxicity of a polyherbal formulation with immunomodulatory properties in Wistar albino rats. The polyherbal formulation comprised of Asparagus racemosus, Withania somnifera, Andrographis paniculata, Ocimum sanctum and Piper nigrum known for their immunomodulatory effects, prepared using the decoction method. In the repeated dose 28-day oral toxicity study, rats were administered polyherbal formulation with different doses ranging from 250 to 1000 mg/kg for 28 days. There were no adverse effects on feed consumption, body weight, hematological parameters, or serum biochemistry were observed. Gross pathology and histopathology assessments further supported the safety of polyherbal formulation, with only mild, incidental changes noted in the lung and liver. Overall, this study suggests that the polyherbal formulation is safe for oral administration in rats.