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

NCT07393958 | Recruiting

• 1 other identifier: ARA-EXP/DOL-2025-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endometriosis (Diagnosis)

Keywords

pain; QoL; food supplement

Outcome Measures

Primary Outcomes (4)

• To measure the improvement of the quality of life.

  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.

  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.

  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.

  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 Outcomes (2)

• Compare the reduction in the need for prescription and dosage of anti-inflammatory and analgesic pharmacological treatment.

  From baseline visit to the final visit at 12 weeks.

• To measure the incidence of clinically relevant episodes

  From Visit 1 (2 weeks) to Visit 4 or Final (12 weeks).

Study Arms (2)

Experimental (Food supplement-Doliral)

EXPERIMENTAL

Patient takes one buccal tablet per day.

Dietary Supplement: Food supplement (T1675)

Control (Placebo)

PLACEBO COMPARATOR

Patient takes one buccal tablet per day.

Other: Placebo

Interventions

Food supplement (T1675) DIETARY_SUPPLEMENT

Doliral is the food supplement, which is the investigational product at this study.

Experimental (Food supplement-Doliral)

Placebo OTHER

Placebo is the control treatment.

Control (Placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients who are able to provide informed consent.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Arafarma Group, S.A.: lead

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Endometriosis; Disease; Pain

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• TAMARA RODRIGUEZ ARAYA, Dr

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tamara Rodríguez Araya, Dr

CONTACT

+34 932 27 54 00; tlrodriguez@clinic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 6, 2026
• Study Start: February 26, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

ES (1)