Impact of Food Supplementation on Quality of Life in Patients With Endometriosis and Pelvic Pain.
Recruiting · NCT07393958 · Interventional (participants receive a specific treatment) · Lead sponsor: Arafarma Group, S.A.
View the official record on ClinicalTrials.gov →Interventions studied
Food supplement (T1675)Placebo
What this trial is about
This study examines whether the food supplement Doliral can improve quality of life and reduce pelvic pain in women with endometriosis, compared with placebo, over several weeks.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed.
- Hospital Clínic de Barcelona - Barcelona, Spain