Experimental Study of Quality of Life in Patients With Endometriosis and Pelvic Pain Treated With Doliral Dietary Supplementation Versus Placebo.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- To measure the improvement of the quality of life.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Experimental (Food supplement-Doliral)
Patient takes one buccal tablet per day.
干预措施: Food supplement (T1675) (Dietary Supplement)
Control (Placebo)
Patient takes one buccal tablet per day.
干预措施: Placebo (Other)
结局指标
主要结局
To measure the improvement of the quality of life.
时间窗: 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.
时间窗: 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).
次要结局
- 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).)