A Single Center, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Tolerability of a Specialized Nutraceutical for Endometriosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Pain relief
研究概览
简要总结
Based on the EHP-30 questionnaire, the pain score and general well-being of all patients will be assessed with and without taking a specialized nutraceutical. These patients will be taking continuous oral contraception, for 3 months before inclusion till at least end of the study or not taking any oral contraception at all during the study due to contraindication(s).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Confirmed endometriosis and/or Positive NMR
- •Mean pain score >6 on the assessment of pelvic pain (Visual analogue scale)
- •Not eligible for surgery in the coming 3 months or had surgery >3 months before inclusion in the study
- •>3 months intake of continue oral contraception (Oestrogen/Progesterone) before inclusion or no intake of oral contraception due to contraindication
- •Has given voluntary, written, informed consent to participate in the study.
排除标准
- •Planned surgery during study
- •<3 month intake of continue oral contraception (Oestrogen/Progesterone) before inclusion
- •Chronic inflammatory disease (Chron's disease, Rheumatism,..)
- •Pregnancy
- •Bariatric surgery
- •Malabsorption issues
- •Allergy or hypersensitivity to the study product:
- •Fish and products thereof: fish oil
- •Soybeans and products thereof
- •Alcohol or substance abuse
- •Start of gonadorelin analogue (ex. Busereline, Gosereline, triptoreline) therapy in the past 6 months
- •Intake of other food supplements, including omega 3 and omega 6
- •Any other condition which in the investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
研究组 & 干预措施
Specialized nutraceutical
Specialized nutraceutical formulated in softgel. Participants are instructed to take 2 softgels orally with some water, one before breakfast and one before diner.
干预措施: Meta19.01 (Dietary Supplement)
Placebo
Identical placebo formulated without active ingredients in softgel. Participants are instructed to take 2 softgels orally with some water, one before breakfast and one before diner.
干预措施: Meta19.01 (Dietary Supplement)
结局指标
主要结局
Pain relief
时间窗: 3 months
pain relief monitored via the Assessment of Pelvic Pain (Visual Analogue scale, VAS) in the Endometriosis Health Profile 30 questions (EHP-30) at baseline and after 3 months of study product intake. The mean of all 3 VAS scales is taken to monitor the evolution of the pain of the subjects. Scores can be given from 0 to 10 with 0 as no pain and 10 as unbearable pain.
次要结局
- General well-being(3 months)
- Inflammation marker C-reactive protein (CRP)(3 months)
- The need for analgesics(3 months)