A prospective, randomized, double-blind, placebo-controlled study on efficacy and safety of Ashwagandha root extract (<i>Withania somnifera</i>) for managing menopausal symptoms in women
Vani I, Muralidhar G, Rao BS
Frontiers in reproductive health · 5 citations
How it was studied
- Design
- Controlled clinical trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Independent funding
Based on full-text disclosure statement.
Publication
- Published
- 2026-01-05 · Front Reprod Health · vol. 7 · p. 1647721
- Publisher
- Frontiers Media
- Cited
- 6 citations · more than 99% of similar papers · 28.0× the field average
- Impact
- Top 10% most cited in its field
- References
- 28 works
- Access
- Open access (journal) · CC-BY
- Research areas
- Menopause: Health Impacts and Treatments · Phytochemicals and Medicinal Plants · Estrogen and related hormone effects
- Keywords
- Disease, Placebo, Clinical trial, Menopause
3 authors
From IN
- Isukapalli Vani · correspondingGovernment General Hospital
- Gudla MuralidharGovernment General Hospital
- B.D. RaoGovernment General Hospital
Abstract
Background
Menopausal hormone therapy (MHT) is one of the most recent therapeutic options available for the management of menopausal symptoms. MHT is used 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.
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, Short Form-12 Health Survey (SF-12) (Quality of Life) score, and Perceived Stress Scale-10 (PSS-10) from baseline to day 56. Tolerability was measured using Patient Global Assessment of Tolerability to Therapy. 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 p p p p p p p p p p < 0.001) compared to PL.
Conclusion
Ashwagandha root extract can be a potential herbal intervention for managing menopausal symptoms in healthy women.
Clinical trial registration
https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=OTk3Mw==&Enc=&userName=, CTRI/2022/02/040551.
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY).
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