CLINICAL TRIAL article
Front. Reprod. Health
Sec. Menopause
This article is part of the Research TopicGlobal Health Perspectives on Empowering Women: Ethnopharmacological Approaches to Overcoming Health Challenges During MenopauseView all 6 articles
A Prospective, Randomized, Double-blind, Placebo-controlled Study on Efficacy and Safety of Ashwagandha Root Extract (Withania somnifera) for Managing Menopausal Symptoms in Women
Provisionally accepted
- 1Professor & Head of Gynaecology, Govt. Medical College & Govt. General Hospital (Old RIMSGGH), Srikakulam, Andhra Pradesh, India
- 2Manager, Dept. of Clinical Research, Govt. Medical College & Govt. General Hospital (Old RIMSGGH), Srikakulam, Andhra Pradesh, India
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Background: Menopausal hormone therapy (MHT) is one of the most recent therapeutic options available for the management of menopausal symptoms. In healthy, symptomatic women under 60 or within 10 years of menopause without contraindications. Still, as many menopausal women use both MHT and antidepressants, safer alternatives are needed. Herbal remedies like Ashwagandha can offer a safer alternative to existing therapies. Ashwagandha aids in hormonal balance, vitality, and reduces stress and fatigue. Objective: The study aimed to assess the efficacy and safety of Ashwagandha root extract (ARE) for managing menopausal symptoms in women. Methods: A randomized, double-blind, placebo-controlled study included 60 women aged 45-55 years who received either ARE or a placebo (PL) for 56 days. The primary outcome was a change in the Menopause Rating Scale (MRS) score from baseline to 56 days. Secondary outcomes were changes in serum hormonal parameters [estradiol, progesterone, luteinizing hormone (LH), and follicle-stimulating hormone (FSH)], hot flash events, SF-12 (Quality of Life) score, and Perceived Stress Scale-10 from baseline to day 56. Tolerability was measured using Patient Global Assessment of Tolerability to Therapy (PGATT). Safety outcomes, such as change in severity and frequency of adverse events, were also assessed from baseline to day 56. Results: At the end of the study, the total MRS score reduced significantly (p<0.0001) with ARE intervention, especially in psychological (p<0.0001), somatic (p<0.0001), and urogenital (p<0.0001) domains as compared to the PL group. Similarly, ARE group showed improved serum estradiol (p<0.001) and progesterone (p<0.001) levels, and increase in Short Form survey (SF-12) scores (p<0.001), while presenting reduced serum FSH (p<0.001) and LH (p<0.001), hot flashes events (p<0.001) and Perceived Stress Scale (PSS-10) scores (p<0.001) compared to PL. Conclusion: Ashwagandha root extract can be a potential intervention for managing menopausal symptoms in healthy women.
Keywords: Ashwagandha Root Extract, Menopause, Safety, efficacy, randomized controlled trial
Received: 24 Jun 2025; Accepted: 26 Nov 2025.
Copyright: © 2025 Vani, Gudla and Bade. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Isukapalli Vani
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