Endometriosis (Diagnosis)
Conditions
Keywords
pain, QoL, food supplement
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.
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.
Interventions
DIETARY_SUPPLEMENTFood supplement (T1675)
Doliral is the food supplement, which is the investigational product at this study.
OTHERPlacebo
Placebo is the control treatment.
Sponsors
Arafarma Group, S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To measure the improvement of the quality of life. | 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). |
| To measure the improvement in pain intensity. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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 | 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). |
Countries
Spain
Contacts
CONTACTTamara Rodríguez Araya, Dr
PRINCIPAL_INVESTIGATORTAMARA RODRIGUEZ ARAYA, Dr
Hospital Clinic of Barcelona
Outcome results
None listed