Doliral food supplement for pelvic pain and quality of life in endometriosis
Experimental Study of Quality of Life in Patients With Endometriosis and Pelvic Pain Treated With Doliral Dietary Supplementation Versus Placebo.
This trial will test whether the food supplement Doliral can reduce pelvic pain and improve quality of life for reproductive-age women with diagnosed endometriosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Arafarma Group, S.A. Industry-sponsored |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT07393958 on ClinicalTrials.gov |
What this trial studies
Participants are randomized 1:1 (30 receive Doliral, 30 receive placebo) and stratified by whether they are on hormonal therapy. Treatment is given from baseline (visit 0) through the final visit (visit 4) with six total clinic visits and daily symptom diaries recording pain and pain medication use. Pain intensity is measured with visual analogue scales for different endometriosis-related pain types and participants complete quality-of-life questionnaires at study visits. The comparison to placebo over several weeks will determine whether Doliral produces meaningful changes in pain scores and quality-of-life measures.
Who should consider this trial
Good fit: Women of reproductive age with laparoscopically or imaging-confirmed endometriosis (ASRM stage I–III) who have had pelvic pain with VAS > 4 in the past three months and who do not currently need surgery are the intended participants.
Not a fit: Patients with more advanced disease (e.g., stage IV), recent related surgery, recent changes in hormone therapy, on excluded analgesic regimens, or who require surgical treatment are unlikely to benefit from this supplement in the context of this trial.
Why it matters
Potential benefit: If successful, Doliral could reduce pelvic pain and improve day-to-day quality of life for some women with endometriosis.
How similar studies have performed: Prior dietary-supplement and nutraceutical trials for endometriosis have shown mixed and mostly preliminary results, with few large, high-quality randomized trials demonstrating clear benefit.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women of reproductive age with diagnosed endometriosis stage I, II, or III, according to the American Society for Reproductive Medicine (ASRM) classification. * Women with a diagnosis of endometriosis confirmed by laparoscopy or, in the absence of laparoscopy, by magnetic resonance imaging (MRI) and/or ultrasound. * Presence of pelvic pain (VAS \> 4) during the last three months. * No indication for surgical intervention at the time of inclusion in the study. * Patients who are able to provide informed consent. Exclusion Criteria: * Patients under 18 years of age. * Use of analgesic or anti-inflammatory pharmacological treatment, except for ibuprofen at doses up to 600 mg/day or naproxen at doses up to 500 mg/day. * Surgery within the year prior to inclusion, performed for therapeutic purposes related to the pathology under study. * Initiation or discontinuation of hormone therapy within the three months prior to inclusion in the study. * Patients with known allergy or hypersensitivity to Doliral®. * Pregnant or breastfeeding patients. * Patients on sick leave: \> 1 year, or With no intention of returning to work, or Undergoing a disability or permanent incapacity assessment process.
Where this trial is running
Barcelona
- Hospital Clínic de Barcelona — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: TAMARA RODRIGUEZ ARAYA, Dr — Hospital Clinic of Barcelona
- Study coordinator: Tamara Rodríguez Araya, Dr
- Email: tlrodriguez@clinic.cat
- Phone: +34 932 27 54 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.