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RecruitingNCT07393958

Impact of Food Supplementation on Quality of Life in Patients With Endometriosis and Pelvic Pain.

Experimental Study of Quality of Life in Patients With Endometriosis and Pelvic Pain Treated With Doliral Dietary Supplementation Versus Placebo.

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Arafarma Group, S.A. · Industry
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

Patients included into the study will be randomized into two treatment groups (30:30 patients). 30 patients will be treated with the food supplement and 30 patients will be treated with placebo. Both groups will be stratified by the presence or absence of hormonal therapy. Patients will be required to attend 6 study visits (selection visit, baseline or visit 0, and visits 1, 2, 3 and final or visit 4). Patients will complete a daily endometriosis symptom diary, which also includes a record of anti-inflammatory and paing medication use. Study treatment will be administred at Visit 0 or Baseline until Visit 4 or Final. At the study visits, patients will be requested to confirm the pain intensity through the VAS scale for different endometriosis pain types. They will be also requested to complete several questionnaires about quality of life.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTFood supplement (T1675)Doliral is the food supplement, which is the investigational product at this study.
OTHERPlaceboPlacebo is the control treatment.

Timeline

Start date
2026-02-26
Primary completion
2026-08-01
Completion
2026-09-15
First posted
2026-02-06
Last updated
2026-03-02

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT07393958. Inclusion in this directory is not an endorsement.

Impact of Food Supplementation on Quality of Life in Patients With Endometriosis and Pelvic Pain. (NCT07393958) · Clinical Trials Directory