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Controlled Trial of Hydrogen Water as a Treatment for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

RecruitingNAAges 18 Years - 65 YearsAllFred Friedberg
NCT07753122 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a 16-week controlled treatment trial of an over-the -counter supplement, hydrogen water, for individuals with ME/CFS patients. An active treatment condition will be compared to a placebo-control condition. The study will also seek confirmation of heart rate variability (HRV) as a biomarker, that is, as a predictor of improvement vs. non-improvement to be assessed at treatment termination. The HRV biomarker hypothesis is based on a finding that High Frequency HRV (cardio-parasympathetic measure) biologically separated improvers and non-improvers in my previous ME/CFS observational study.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients aged 18-65 of both sexes * considered physically capable and willing to perform the study tasks * Meet validated phone-screen eligibility for ME/CFS criteria * Participant has internet and computer Exclusion Criteria: * 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. Kidney disease/renal failure is also an exclusion * 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\>35 \_\_\_\_Patients regularly taking therapeutic magnesium. * 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.
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What it tests

  • Placebo condition
  • Molecular hydrogen produced by a metallic magnesium tablet, consumed 3x a day dissolved in water. Treatment duration is 16 weeks.
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Where

1 site
Stony Brook University
Stony Brook, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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