Hydrogen Water as a Treatment for Chronic Fatigue Syndrome: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Fatigue Severity Scale
研究概览
简要总结
The proposed placebo-controlled pilot study will examine hydrogen water as a treatment for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). 25 subjects who meet strict criteria for ME/CFS will be recruited. The 30 day trial will involve subjects ingesting 1-5 8 oz. glasses of hydrogen-dissolved water per day. The placebo condition will involve the same daily ingestion schedule but with an inert placebo pill instead of the active hydrogen treatment pill. The proposed study is intended to establish feasibility of the clinical protocol and examine potential treatment effects of hydrogen water which may include symptom reduction and possibly improved functioning. If feasibility and apparent treatment effects are confirmed, a large clinical trial will be proposed for submission to NIH. In addition to potential therapeutic properties, H2 water is portable, easily administered and safe to ingest.
Self-report assessments for ME/CFS symptoms, fatigue, autonomic symptoms, physical function, anxiety, and depression will be done in the week before and the week after the 30 day trial. In addition, 7-day home-based objective assessments of heart rate variability (a measure of parasympathetic function) and accelerometry (a physical activity assessment) will be scheduled before and after the intervention period.
详细描述
SPECIFIC AIMS
The aim of this pilot randomized control trial (RCT) is to explore the possible beneficial effect of a novel therapy, molecular hydrogen (H2) for the symptoms and related functional limitations in patients with chronic fatigue syndrome.
BACKGROUND AND SIGNIFICANCE Oxidative stress and impaired energy metabolism have been implicated in the pathophysiology of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), a debilitating illness without clearly identified etiology or effective medical treatments. As such, treatments that reduce oxidative stress and yield improvements in energy production may show potential to ameliorate the symptoms and functional limitations of this illness. Numerous publications on the biological and medical benefits of H2 have shown that H2 reduces oxidative stress not only by direct reactions with strong oxidants, but also indirectly by regulating various gene expressions. In addition to its potential therapeutic properties for ME/CFS, H2 water is portable, easily administered and safe to ingest.
PRELIMINARY STUDIES
The proposed study is a pilot study in ME/CFS for which there are no directly applicable preliminary studies utilizing the proposed H2 therapy.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Pills for both conditions look very similar and each group sees only the pill assigned to that group (H2 or placebo) and not the pill assigned to the other group. Also neither the outcome assessor nor the investigator know which condition that specific individual subjects are assigned to. This is because a blocked randomization schedule of numbers (1s and 2s) is used to assign each consecutive subject enrolled in the study to one of the study conditions. The code that links each subject to an identifiable condition assignment is known only by the PI and not the staff who selects the pills to be sent out to each subject or by the outcomes assessor. Also the subject fills out online outcome forms that involve no interaction with study staff, thus avoiding any staff-specific influence on online outcome forms.
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic fatigue, chronic fatigue syndrome, ME/CFS or something similar.
- •age 21-65
排除标准
- •Other major medical condition or regular medication that produces fatigue.
- •No home computer
- •No internet access
结局指标
主要结局
Fatigue Severity Scale
时间窗: 4 weeks
Fatigue Severity Scale; Minimum value=1; Maximum value=7; Range: 1.00-7.00. Higher scores indicate a worse outcome.
次要结局
- Short Form-36 Physical Function Subscale(4 weeks)
- Pittsburgh Sleep Quality Index(4 weeks)
- Depression, Anxiety, and Stress Scale(4 weeks)
研究者
Fred Friedberg
Research Associate Professor
Stony Brook University