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 citas
Cómo se estudió
- Diseño
- Ensayo clínico controlado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
Según la declaración de financiación del texto completo.
Publicación
- Publicado
- 2026-01-05 · Front Reprod Health · vol. 7 · pág. 1647721
- Editorial
- Frontiers Media
- Citado
- 6 citas · más que el 99% de estudios similares · 28.0× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 28 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY
- Áreas de investigación
- Menopause: Health Impacts and Treatments · Phytochemicals and Medicinal Plants · Estrogen and related hormone effects
- Palabras clave
- Disease, Placebo, Clinical trial, Menopause
3 autores
- Isukapalli Vani🇮🇳 · autor de correspondenciaGovernment General Hospital
- Gudla Muralidhar🇮🇳Government General Hospital
- B.D. Rao🇮🇳Government General Hospital
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).
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