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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000021154 |
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Date of registration:
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23/02/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 - Effects of hydrogen tablet on blood pressure and endothelial function |
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Date of first enrolment:
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2016/02/23 |
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Target sample size:
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34 |
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Recruitment status: |
Recruiting |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024401 |
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Study type:
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Interventional |
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Study design:
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Cross-over Randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Masaki
Sakurada |
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Address:
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2-61-11 Kamiarai, Tokorozawa, Saitama, JAPAN
Japan |
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Telephone:
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04-2940-8611 |
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Email:
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ayaori@ba2.so-net.ne.jp |
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Affiliation:
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Tokorozawa Heart Center Department of Cardiology |
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Name:
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Hirotaka
Ezaki |
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Address:
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2-61-11 Kamiarai, Tokorozawa, Saitama, JAPAN
359-1142
Japan |
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Telephone:
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04-2940-8611 |
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Email:
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hirotakaezaki@gmail.com |
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Affiliation:
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Tokorozawa Heart Center Department of Cardiology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion 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
Age minimum:
20years-old
Age maximum:
80years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Hypertension
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Intervention(s)
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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
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Primary Outcome(s)
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Blood pressure (On visit/Home monitoring/24 hr ambulatory) Flow-mediated vasodilation in forearm 12 weeks after administration
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Secondary Outcome(s)
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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
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Source(s) of Monetary Support
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Foundation for Promotion of Defense Medicine
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Ethics review
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Status: YES
Approval date:
Contact:
cs.thc@oukai.or.jp
Etics commitee of Tokorozawa Heart Center
04-2940-8611
cs.thc@oukai.or.jp
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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