跳至主要内容
临床试验/NCT06227273
NCT06227273招募中不适用

Hydrogen Water Dosing Study for ME/CFS and Chronic Fatigue

Stony Brook University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Fatigue Severity Scale

研究概览

简要总结

The aim of this 16-week pilot randomized trial is to explore the potential benefit of the OTC supplement hydrogen water, for the symptoms of chronic fatigue syndrome (CFS). Methods: This 16-week home-based trial will compare two groups: (1) low dose hydrogen water (2-3 glasses/day) for all 16 weeks; and (2) low dose followed by high dose hydrogen water (up to 5 glasses/day). Condition (2) involves an initial 8 weeks of low dose H2 followed by 8 weeks of high dose H2 in order to test the premise that the higher dosage will be more effective with fewer adverse effects if preceded by several weeks of low dose H2. Outcomes measures will include online assessments of fatigue, physical function and stress. A salivary biomarker for oxidative stress, Uric Acid, will also be assessed.

详细描述

Previous clinical studies (8-12 week intervention trials) have indicated that H2 enriched water reduces concentrations of markers of oxidative stress in patients with metabolic syndrome, improves lipid and glucose metabolism in patients with type 2 diabetes, improves mitochondrial dysfunction in patients with mitochondrial myopathies, and reduces inflammatory processes in patients with polymyositis/ dermatomyositis (Mizuno et al., 2017). In addition to its potential therapeutic properties, H2 water is portable, easily administered and safe to ingest (Nagata et al., 2013). Owing to its potential therapeutic efficacy and lack of adverse effects, H2 may show promise for clinical use in ME/CFS. Two CFS studies conducted in the PI's laboratory (Friedberg and Choi, 2022; Friedberg and Choi, under review) yielded mixed findings. The initial randomized controlled trial showed no benefit for H2 water, but the second study, a randomized trial of H2 and heart rhythm biofeedback that was of longer duration (60 days) with a lower dosage of H2 water found significant improvements in fatigue and physical function. The new proposed randomized trial will extend treatment to 120 days and test a standard dosage of H2 water for all 120 days in group1 in comparison to standard dosage for the initial 60 days followed by increased dosage for the remaining 60 days (Group 2). Group 2 is may show a greater treatment effect once subjects are acclimated to the lower initial dose. Thus, we are testing different dosing schedules to determine which may be more effective in CFS.

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
Single (Investigator)

盲法说明

The investigator is blinded to computer-generated condition assignment.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18-65 of both sexes; considered physically capable and willing to perform the study tasks.
  • Meeting validated phone-screen eligibility for ME/CFS criteria.
  • Patient has internet and computer.

排除标准

  • Cases of fatigue clearly attributable to self-report medical conditions such as untreated hypothyroidism, unstable diabetes mellitus, organ failure, chronic infections, and chronic inflammatory diseases, or AIDS.
  • __ Exclusionary psychiatric disorders include any psychosis, or alcohol/ substance abuse within two years prior to illness onset and any time afterward, and current or past depression with melancholic or psychotic features within 5 years prior to onset of ME/CFS or anytime afterward
  • Pregnancy is an exclusion.
  • Patients with BMI>
  • Patients at significant risk of suicide or in need of urgent psychiatric treatment. As much as possible, appropriate medical and psychiatric referrals to facilities local to subjects will be provided.

结局指标

主要结局

Fatigue Severity Scale

时间窗: 16 weeks

Self-report measure of effect of fatigue on functioning.

次要结局

  • SF-36 PF(16 weeks)
  • Depression, Anxiety and Stress Scale(16 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fred Friedberg

Principal Investigator

Stony Brook University

研究点 (2)

Loading locations...

相似试验

Hydrogen Water Dosing Study for ME/CFS | 临床试验