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Effects of Ashwagandha Supplementation on Quality of Life and Well-Being in Women With Endometriosis
Sponsor: Medical University of Vienna
Summary
The goal of this clinical trial is to learn how ashwagandha, a herbal dietary supplement, affects quality of life in women with endometriosis. Researchers will also assess how well participants tolerate it. The main questions are: * Does ashwagandha affect mental well-being and quality of life compared with placebo? * Does it affect physical health, perceived stress, or endometriosis-related quality of life? * Does it affect pain during intercourse or how participants manage pain, including pain medication use? * What side effects or changes in blood test results occur during supplementation? Researchers will compare ashwagandha with a placebo, a look-alike capsule containing no active ingredient. The study will include 90 women. A chance process will assign participants to a group. Each participant has a two-in-three chance of receiving ashwagandha. Neither participants nor researchers assessing the results will know who receives ashwagandha during this phase. Participants will: * Take 300 mg of ashwagandha or placebo daily for 12 weeks. This may extend to 16 weeks to match assessments with the menstrual cycle. * Complete questionnaires about quality of life, stress, pain during intercourse, and pain management. * Attend regular clinic visits for health checks and blood tests. * Attend a follow-up visit about four weeks after finishing the study capsules. After the first phase, eligible participants may choose to continue for another 12 weeks. Everyone in this optional phase will take ashwagandha and know they are taking it. Researchers will track further changes in quality of life, stress, and side effects. Participants will continue their usual care for endometriosis. Whether ashwagandha benefits women with endometriosis is not yet known.
Official title: An Exploratory Study of Participant-reported Well- Being During Ashwagandha Supplementation in Women With Endometriosis
Key Details
Gender
FEMALE
Age Range
18 Years - 51 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2026-11
Completion Date
2028-07
Last Updated
2026-10-27
Healthy Volunteers
No
Interventions
Ashwagandha
The product is commercially available as the root and leaf extract, SHODEN®, 300 mg per capsule, standardized to at least 30% withanolides.
placebo capsule
Matching placebo (capsules containing an inert filler, identical in appearance, taste, and smell to the active study product)
Locations (1)
Department of Clinical Pharmacology, Medical University Vienna, Vienna General Hospital
Vienna, Austria