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Prospective, randomized, open-label, clinical trial comparing the effects of hydrogen tablet and placebo on blood pressure, endothelial function and makers for cardiovascular diseases

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Hypertension
Date of first enrollment	2016/02/23
Target sample size	34
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	hydrogen tablet 2tab/day for 12 weeks > placebo 2tab/day for 12 weeks placebo 2tab/day for 12 weeks > hydrogen tablet 2tab/day for 12 weeks

Outcome(s)

Primary Outcome	Blood pressure (On visit/Home monitoring/24 hr ambulatory) Flow-mediated vasodilation in forearm 12 weeks after administration
Secondary Outcome	Markers indicating obesity (e.g. adiponectin), inflammation (high sensitive CRP), oxidative stress (8-OHdG/ MDA-LDL), early-staged kidney diseases (microalbuminuria) 12 weeks after administration

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	80years-old
Gender	Male and Female
Include criteria
Exclude criteria	1) Poor-controlled hypertension (DBP>110) 2) Poor-controlled diabetes (HbA1c>8.0 %) 3) Secondary hypertension 4) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months 5) Either level of aspartate aminotransaminase or alanine aminotransferase exceeds three-fold of the normal limits. 6) End stage renal disease 7) Symptomatic (NYHA III or IV) congestive heart failure 8) Malignancies or other diseases with poor prognosis 9) Subjects whose doctor in charge do not agree to join the trial