Effects of Ashwagandha Supplementation on Quality of Life and Well-Being in Women With Endometriosis
NCT07898670
· ctgov
not_yet_recruiting
- Enrollment
- 90
- Start
- 2026-11-01
- Completion
- 2028-07-01
- Last updated
- 2026-10-27
- Has results
- False
- Countries
- Austria
Conditions
Tagged with
Interventions
-
Ashwagandha
DIETARY_SUPPLEMENT
The product is commercially available as the root and leaf extract, SHODEN®, 300 mg per capsule, standardized to at least 30% withanolides.
-
placebo capsule
DRUG
Matching placebo (capsules containing an inert filler, identical in appearance, taste, and smell to the active study product)
Eligibility criteria
Inclusion Criteria:
* 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 Criteria:
* current or recent use of oral hormonal therapies within 4 weeks before screening
* use of hormonal depot therapy within 3 months before screening
* hysterectomy, bilateral oophorectomy, or endometrial ablation resulting in amenorrhea
* pregnancy, lactation, or pregnancy planned during the study period
* history of liver disease or clinically relevant liver injury of any cause, including viral, alcohol-related, or autoimmune
* abnormal liver function tests (ALT, AST, or bilirubin above the upper limit of normal) at screening
* severe renal impairment
* active autoimmune disease or malignant disease
* use of systemic immunosuppressants or glucocorticoids within the last 3 months
* use of supplements containing Ashwagandha, curcumin, or other adaptogens or anti- inflammatory supplements within 4 weeks before screening
* hypersensitivity to herbal products or study excipients
* participation in another clinical trial within the last 1 month
* any other objection to participation in the opinion of the investigator
License: public-domain-us
· commercial use OK
· attribution required
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine