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.
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 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.
Parallel
Food supplement (T1675)
Dietary supplementDoliral is the food supplement, which is the investigational product at this study.
Placebo
Other interventionPlacebo is the control treatment.
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).
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.
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).
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).
Compare the reduction in the need for prescription and dosage of anti-inflammatory and analgesic pharmacological treatment.
Patients will complete the use of inflammatory and analgesic pharmacological treatment (name, dose and time) in a diary between visits.
To measure the incidence of clinically relevant episodes
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).
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