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

EndometriosisQuality of LifePainPerceived StressPsychological Well Being

Tagged with

endometriosis

Interventions

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

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