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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental (Food supplement-Doliral) | Experimental | Patient takes one buccal tablet per day. |
|
| Control (Placebo) | Placebo Comparator | Patient takes one buccal tablet per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Food supplement (T1675) | Dietary Supplement | Doliral is the food supplement, which is the investigational product at this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline visit to the final visit at 12 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tamara RodrÃguez Araya, Dr | Contact | +34 932 27 54 00 | tlrodriguez@clinic.cat |
| Name | Affiliation | Role |
|---|---|---|
| TAMARA RODRIGUEZ ARAYA, Dr | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnic de Barcelona | Recruiting | Barcelona | 08036 | Spain |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D004194 | Disease |
| D010146 | Pain |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Placebo | Other | Placebo is the control treatment. |
|
| From baseline visit to the final visit at 12 weeks. |
| 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). |
| From Visit 1 (2 weeks) to Visit 4 or Final (12 weeks). |
| D000091662 | Genital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |