An Unicentric, Double-blind, Placebo Controlled, Phase IV Clinical Trial of Oral Melatonin Plus Zinc to Evaluate Relieving Self-reported Fatigue in CFS/ME
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- To evaluate relieving self-reported fatigue using the Fatigue Impact Scale 40-items (FIS 40) questionnaire after oral melatonin plus zinc administration
研究概览
简要总结
The purpose of this study is to evaluate the effects of oral melatonin plus zinc supplementation in relieving self-reported fatigue in CFS/ME
详细描述
Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) is a complex medical condition, characterized by severe disabling fatigue with no known cause, no established diagnostic tests, and no universally effective treatment. No studies have evaluated symptomatic treatment using oral melatonin plus zinc supplementation in CFS/ME. The primary endpoint was to assess the effect of melatonin plus zinc supplementation on self-reported fatigue. Secondary measures included self-reported outcomes of sleep problems, anxiety/depression, dysautonomia, QoL and side-effects during treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •CFS patient based on the 1994 Centers for Disease Control and Prevention/Fukuda definition.
- •Patient who provided signed informed consent.
排除标准
- •Patients who are participating in another clinical trial of the same or different nature previous 30 days prior to inclusion.
- •Any subject that, in the judgment of the investigator, is not able to follow the instructions or to perform a good completion of the treatment.
- •Subjects that do not provide signed informed consent.
- •Patients who are receiving any of the drugs or products that may interfere with the results, and whose withdrawal could be a relevant medical problem.
- •Patients receiving oral anticoagulants.
- •Pregnancy or lactation
- •Patients with hypersensitivity to melatonin and/or zinc.
结局指标
主要结局
To evaluate relieving self-reported fatigue using the Fatigue Impact Scale 40-items (FIS 40) questionnaire after oral melatonin plus zinc administration
时间窗: within the first 16 weeks (plus 4 weeks with no treatment)
次要结局
- Self-reported sleep quality through the Pittsburgh Sleep Quality Index (PSQI) questionnaire.(within the first 16 weeks (plus 4 weeks with no treatment))
- Self-reported dysautonomia using the Composite Autonomic Symptom Score 31-items (COMPASS 31) questionnaire.(within the first 16 weeks (plus 4 weeks with no treatment))
- Self-reported QoL through the Short Form Health Survey 36-items (SF-36) questionnaire.(within the first 16 weeks (plus 4 weeks with no treatment))
- Side effects during treatment.(within the first 16 weeks (plus 4 weeks with no treatment))
- Self-reported anxiety/depression through the Hospital Anxiety and Depression Scale (HADS) questionnaire.(within the first 16 weeks (plus 4 weeks with no treatment))