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.
9 affiliations
- 1Department of Psychiatry, University of Texas, Houston, TX, USA.
- 2Department of Psychiatry, Central Prison Hospital, Department of Health and Family Welfare, Government of Karnataka, Bengaluru, KA, India.
- 3Department of Psychiatry, Bangalore Medical College and Research Institute, Bengaluru, KA, India.
- 4Department of Psychiatry, KJ Somaiya Medical College and Research Center, Mumbai, MH, India.
- 5Department of Psychiatry, The Mind Clinic, Chennai, TN, India.
- 6Department of Psychiatry, Interdisciplinary Institute of Indian System of Medicine (IIISM), SRM Institute of Science & Technology, Chennai, TN, India.
- 7Department of Psychiatry, Gangoshri Hospital, Varanasi, UP, India.
- 8Research & Development Centre, Himalaya Wellness Company, Bengaluru, KA, India.
- 9Medical Services & Clinical Development, Himalaya Wellness Company, Bengaluru, KA, India.
Abstract
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 (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. 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. 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.
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BibTeX
@article{gajwani2026evaluation,
title = {{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.}},
author = {Prashant Gajwani and Santhosh J and Chillal Guru Prasad and Veena Sagar Gholap and Sai Balasubramanian Dheenadhayalan and Satish Kumar Rajappan Chandra and Pradeep Chaurasia and U V Babu and Rajesh Kumawat},
journal = {Neuropsychiatric disease and treatment},
year = {2026},
month = oct,
doi = {10.2147/ndt.s633019},
url = {https://europepmc.org/article/MED/42953409},
note = {CC BY-NC},
}
RIS
TY - JOUR
TI - 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.
AU - Prashant Gajwani
AU - Santhosh J
AU - Chillal Guru Prasad
AU - Veena Sagar Gholap
AU - Sai Balasubramanian Dheenadhayalan
AU - Satish Kumar Rajappan Chandra
AU - Pradeep Chaurasia
AU - U V Babu
AU - Rajesh Kumawat
PY - 2026
DA - 2026/10/24
JO - Neuropsychiatric disease and treatment
DO - 10.2147/ndt.s633019
UR - https://europepmc.org/article/MED/42953409
AB - 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 (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. 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. 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.
SN - 1176-6328
SN - 1178-2021
ER -