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

February 27, 2026 updated by: Arafarma Group, S.A.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic De Barcelona
        • Contact:
          • Tamara Rodíguez Licensed Physician, Specialist in Rheumatology, Dr
          • Phone Number: 93 227 54 00
          • Email: tlrodriguez@clinic.cat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental (Food supplement-Doliral)
Patient takes one buccal tablet per day.
Dietary supplement: Food supplement (T1675)
Doliral is the food supplement, which is the investigational product at this study.
Placebo Comparator: Control (Placebo)
Patient takes one buccal tablet per day.
Other: Placebo
Placebo is the control treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To measure the improvement of the quality of life.
Time Frame: From baseline visit to the final visit at 12 weeks.
Patients complete EQ-5D-5L questionnaire at Day 1 (baseline visit), at 2 weeks (Visit 1), at 4 weeks (Visit 2), at 8 weeks (Visit 3) and at 12 weeks (Visit 4). This questionnaire measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression and health status. These five dimensions have 5 response levels: No problems, slight problems, moderate problems, severe problems and extreme problems. This questionnaire also has a Visual Analogue Scale from 0 (worse health status) to 100 (best health status).
From baseline visit to the final visit at 12 weeks.
To measure the improvement of the quality of life.
Time Frame: From baseline visit to the final visit at 12 weeks.
Patients complete the Endometriosis Health Profile 30 Questionnaire at Day 1 (baseline visit), at 2 weeks (Visit 1), at 4 weeks (Visit 2), at 8 weeks (Visit 3) and at 12 weeks (Visit 4). This questionnaire evaluates six domains: pain, control and powerlessness, emotional well-being, social support and self-image. These scales are converted into a 0-100 score, 0 is best health status and 100 is worse quality of life.
From baseline visit to the final visit at 12 weeks.
To measure the improvement of the quality of life.
Time Frame: From baseline visit to the final visit at 12 weeks.
Patients complete PGI-I (Patient Global Impression of Improvement) scale at Day 1 (baseline visit), at 2 weeks (Visit 1), at 4 weeks (Visit 2), at 8 weeks (Visit 3) and at 12 weeks (Visit 4). PGI-I is a Likert scale from 1 (significantly better) to 7 (significantly worse).
From baseline visit to the final visit at 12 weeks.
To measure the improvement in pain intensity.
Time Frame: From baseline visit to the final visit at 12 weeks.
To describe the type and intensity of pain using a Visual Analogue Scale (VAS) at at Day 1 (baseline visit), at 2 weeks (Visit 1), at 4 weeks (Visit 2), at 8 weeks (Visit 3) and at 12 weeks (Visit 4). It is measured the change of these results from baseline visit to the final visit. Also patients complete a symptoms diary between visits. For each symptom, the patient will record intensity (on a scale from 1 to 10).
From baseline visit to the final visit at 12 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the reduction in the need for prescription and dosage of anti-inflammatory and analgesic pharmacological treatment.
Time Frame: From baseline visit to the final visit at 12 weeks.
Patients will complete the use of inflammatory and analgesic pharmacological treatment (name, dose and time) in a diary between visits.
From baseline visit to the final visit at 12 weeks.
To measure the incidence of clinically relevant episodes
Time Frame: From Visit 1 (2 weeks) to Visit 4 or Final (12 weeks).
To assess and destribe the type, intensity and relationship with investigational product of clinically relevant episodes at Day 1 (baseline visit), at 2 weeks (Visit 1), at 4 weeks (Visit 2), at 8 weeks (Visit 3) and at 12 weeks (Visit 4).
From Visit 1 (2 weeks) to Visit 4 or Final (12 weeks).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arafarma Group, S.A.

Investigators

  • Principal Investigator: TAMARA RODRIGUEZ ARAYA, Dr, Hospital Clinic of Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 15, 2026

Study Registration Dates

First Submitted

January 30, 2026

First Submitted That Met QC Criteria

January 30, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARA-EXP/DOL-2025-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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