In-vivo Safety Assessment of a Polyherbal Formulation (Stress-WIN) Proposed for Clinical Hypertension Management

Abstract

Abstract 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 Stress-WIN is not available yet. The present study aims to evaluate the Stress-WIN'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 Stress-WIN, 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 Stress-WIN treated groups in comparison to the control group (p > 0.05). Findings from the present study suggest that Stress-WIN 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 Stress-WIN was higher than 2000 mg/kg/day.