Work

Evaluation of the Efficacy and Safety of Ashwagandha Caplet in Patients Suffering from Mild to Moderate Stress and Anxiety Disorders: A Multicentric, Double-Blind, Randomized, Placebo-Controlled, Clinical Trial

Year: 2026

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: Purpose: Anxiety disorders are the most common mental disorders worldwide, affecting more than 359 million people. The COVID-19 pandemic is projected to increase the global prevalence of anxiety and depression by approximately 25%. Despite this significant burden, a notable treatment gap persists globally across high-income and low- and middle-income countries. The present study aimed to evaluate the safety and efficacy of Ashwagandha caplet in reducing the signs and symptoms of patients with mild to moderate stress and anxiety disorders. Patients and Methods: Patients (n=226) with mild to moderate stress and anxiety were assessed using the Hamilton Anxiety Rating Scale (HAM-A) and the Perceived Stress Scale (PSS-10) and randomized to receive either Ashwagandha caplet (n=112) or placebo caplet (n=114) once a day after food preferably at night for 8 weeks in a double-blind fashion. Reduction in HAM-A and PSS-10 scores were considered the primary outcomes, while improvements in mental well-being, fatigue, and safety evaluations were considered secondary outcomes. Intention-to-treat (ITT) and per-protocol (PP) analyses were performed for all efficacy parameters. Results: Ashwagandha caplet showed statistically significant (p<0.0001) improvement in stress (PSS-10), anxiety (HAM-A), and mental well-being (General Health Questionnaire-12) in patients with mild to moderate stress and anxiety compared to placebo by both ITT and PP analyses. Superiority analysis (as per USFDA guidelines) further indicated that the effect of Ashwagandha caplet was superior to placebo in reducing stress (PSS-10) and anxiety (HAM-A) in both the ITT and PP analyses. No drug- related or serious adverse events were reported throughout the study. Conclusions: Ashwagandha caplet once a day for 8 weeks proved to be effective, safe, and superior to placebo in the management of signs and symptoms in patients suffering from mild to moderate stress and anxiety.

Source: Neuropsychiatric Disease and Treatment

DOI: 10.2147/ndt.s633019