Ashwagandha supplement and well-being in women with endometriosis
Tests ashwagandha against a placebo for quality of life in women with endometriosis.
Plain-language title generated from the registry record
Registry title: Effects of Ashwagandha Supplementation on Quality of Life and Well-Being in Women With Endometriosis
Key facts
- Where
- Vienna, AustriaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 51 years old?
Source: NCT07898670, who can take part
Where in Austria
- Department of Clinical Pharmacology, Medical University Vienna, Vienna General HospitalVienna, AustriaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medical University of Vienna
- Trial code
- NCT07898670
- Record updated
- 27 October 2026
- Original description
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.Read full original descriptionShow less
An Exploratory Study of Participant-reported Well- Being During Ashwagandha Supplementation in Women With Endometriosis
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.
Inclusion: 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.
Exclusion: 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; 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; abnormal liver function tests (ALT, AST, or bilirubin above the upper limit of normal) at screening; 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.