UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021154 |
|---|---|
| Receipt number | R000024401 |
| Scientific Title | Prospective, randomized, open-label, clinical trial comparing the effects of hydrogen tablet and placebo on blood pressure, endothelial function and makers for cardiovascular diseases |
| Date of disclosure of the study information | 2016/02/23 |
| Last modified on | 2023/02/28 20:00:22 |
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Basic information
Public title
Prospective, randomized, open-label, clinical trial comparing the effects of hydrogen tablet and placebo on blood pressure, endothelial function and makers for cardiovascular diseases
Acronym
Effects of hydrogen tablet on blood pressure and endothelial function
Scientific Title
Prospective, randomized, open-label, clinical trial comparing the effects of hydrogen tablet and placebo on blood pressure, endothelial function and makers for cardiovascular diseases
Scientific Title:Acronym
Effects of hydrogen tablet on blood pressure and endothelial function
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare effects of hydrogen tablet and placebo on blood pressure, endothelial function and makers for cardiovascular diseases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure (On visit/Home monitoring/24 hr ambulatory)
Flow-mediated vasodilation in forearm
12 weeks after administration
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
hydrogen tablet 2tab/day for 12 weeks
>
placebo 2tab/day for 12 weeks
Interventions/Control_2
placebo 2tab/day for 12 weeks
>
hydrogen tablet 2tab/day for 12 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) hypertensive patients on treatment
2) Out patients
Key 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
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Sakurada |
Organization
Tokorozawa Heart Center
Division name
Department of Cardiology
Zip code
359-1142
Address
2-61-11 Kamiarai, Tokorozawa, Saitama, JAPAN
TEL
04-2940-8611
ayaori@ba2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Hirotaka |
| Middle name | |
| Last name | Ezaki |
Organization
Tokorozawa Heart Center
Division name
Department of Cardiology
Zip code
359-1142
Address
2-61-11 Kamiarai, Tokorozawa, Saitama, JAPAN
TEL
04-2940-8611
Homepage URL
hirotakaezaki@gmail.com
Sponsor or person
Institute
Tokorozawa Heart Center
Institute
Department
Personal name
Funding Source
Organization
Foundation for Promotion of Defense Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Etics commitee of Tokorozawa Heart Center
Address
2-61-11 Kamiarai, Tokorozawa, Saitama, JAPAN
Tel
04-2940-8611
cs.thc@oukai.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2016 | Year | 01 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 23 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 23 | Day |
Last modified on
| 2023 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024401
