NCT07898670Not yet recruiting
Effects of Ashwagandha Supplementation on Quality of Life and Well-Being in Women With Endometriosis
An Exploratory Study of Participant-reported Well- Being During Ashwagandha Supplementation in Women With Endometriosis
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 16 Oct 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- Medical University of Vienna
- Diseases
- Endometriosis
- NCT number
- NCT07898670
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 1 Nov 2026 to the primary completion date, 1 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- current or recent use of oral hormonal therapies within 4 weeks before screening
- use of hormonal depot therapy within 3 months before screening
- use of supplements containing Ashwagandha, curcumin, or other adaptogens or anti- inflammatory supplements within 4 weeks before screening
Other illness
- history of liver disease or clinically relevant liver injury of any cause, including viral, alcohol-related, or autoimmune
- severe renal impairment
- active autoimmune disease or malignant disease
- hypersensitivity to herbal products or study excipients
Lab values
- abnormal liver function tests (ALT, AST, or bilirubin above the upper limit of normal) at screening
Other
- hysterectomy, bilateral oophorectomy, or endometrial ablation resulting in amenorrhea
- pregnancy, lactation, or pregnancy planned during the study period
- use of systemic immunosuppressants or glucocorticoids within the last 3 months
- participation in another clinical trial within the last 1 month
- any other objection to participation in the opinion of the investigator
Who the study is looking for
- Written informed consent given by participants after being provided detailed information about the nature, risks, and scope of the study
- Premenopausal women aged 18-51 years.
- Clinically confirmed diagnosis of endometriosis by laparoscopy within the past 10 years, ultrasound, and/or imaging (TVUS/MRI) showing endometrioma, adenomyosis, or deep-infiltrating endometriosis within 6 months.
- EHP-30 score of more than 40.
- Participant-reported pelvic pain, defined as dysmenorrhea and/or non-menstrual pelvic pain of ≥4 on NRS on at least 5 days during a 28-day screening phase
- If sexually active and of childbearing potential: agreement to use a highly effective non- hormonal double-barrier method (e.g., condom plus diaphragm, condom plus spermicide, copper intrauterine device, or partner vasectomy)
- Ability to provide informed consent and complete questionnaires.
Age in the registry: 18 years to 51 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Clinical Pharmacology, Medical University Vienna, Vienna General Hospital Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.