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Hydrogen Water for Chronic Fatigue Syndrome

(ME/CFS Trial)

FF
Overseen ByFred Friedberg, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Fred Friedberg

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

FF

Fred Friedberg, PhD

Principal Investigator

Stony Brook University

Are You a Good Fit for This Trial?

This trial is for people diagnosed with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Specific inclusion and exclusion criteria are not listed, but generally participants should have ME/CFS and be able to take part in a 16-week study.

Inclusion Criteria

I am physically able and willing to do all study tasks.
Meet validated phone-screen eligibility for ME/CFS criteria
I am between 18 and 65 years old.
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Exclusion Criteria

My fatigue is caused by an untreated or unstable medical condition.
Exclusionary psychiatric disorders including any psychosis, 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
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What Are the Treatments Tested in This Trial?

Interventions

  • Molecular hydrogen water

Trial Overview

The study tests whether drinking hydrogen water (made by dissolving magnesium tablets in water) three times daily helps people with ME/CFS compared to a placebo. The treatment lasts for 16 weeks, and heart rate variability will also be measured as a possible marker of improvement.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Active hydrogen water interventionExperimental Treatment1 Intervention
Group II: Placebo conditionPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Fred Friedberg

Lead Sponsor

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