In vivo safety assessment of a polyherbal formulation (Stress WIN) proposed for clinical hypertension management

Herbal treatments are nowadays considered dietary supplements and nutraceuticals for health maintenance and alternative/complementary therapy. A large range of herbal medications worldwide can easily be accessible in the local market. The polyherbal formulation (Stress WIN) containing Ashwagandha (Withania somnifera L. Dunal), Pushkarmoola (Inula racemosa Hook. F.), and Jatamansi (Nardostachys jatamansi (D. Don) DC.) root has been used empirically in the management of hypertension. However, toxicity data for the StressWIN is not available yet. The present study aims to evaluate the StressWIN’s safety profile by 28 days of repeated dose oral toxicity in Wistar rats. Rats received different doses (500 mg/kg/day, 1000 mg/kg/day, and 2000 mg/kg/day) of StressWIN, for 28 days. The study was conducted in compliance with the OECD guideline 423. No significant differences were observed in hematological and biochemical parameters as compared to the control group (p > 0.05). Histopathological studies revealed no significant alterations in the macroscopic and microscopic architecture of the liver, kidney, heart, and spleen of the StressWIN treated groups in comparison to the control group (p > 0.05). Findings from the present study suggest that StressWIN supplementation has not shown any side effects in terms of sub-acute toxicity in both male and female rats. These findings indicated no observed adverse effect level (NOAEL) of StressWIN was higher than 2000 mg/kg/day. Article highlights Provides valuable data on the sub-acute toxicity of Stress WIN in rats. Stress WIN is a safe drug up to a dose of 2000 mg/kg body weight in sub-acute toxicity study. Histopathological examinations showed no alterations in the tissues were found in this study.