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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032701
Receipt No. R000037292
Scientific Title Prospective, randomized, open-label,clinical trial comparing the effects of hydrogen tablet and placebo on blood and urine makers for cardiovascular diseases
Date of disclosure of the study information 2019/05/24
Last modified on 2018/05/24

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Basic information
Public title Prospective, randomized, open-label,clinical trial comparing the effects of hydrogen tablet and placebo on blood and urine makers for cardiovascular diseases
Acronym Effects of hydrogen tablet on blood and urine makers
Scientific Title Prospective, randomized, open-label,clinical trial comparing the effects of hydrogen tablet and placebo on blood and urine makers for cardiovascular diseases
Scientific Title:Acronym Effects of hydrogen tablet on blood and urine makers
Region
Japan

Condition
Condition cardiovascular disease, diabetes and dyslipidemia
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare effects of hydrogen tablet and placebo on blood and urine biomakers for cardiovascular diseases
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Markers indicating oxidative stress (Oxidized albumin, isoprostane, 8-OHdG, MDA-LDL, FABP)
4 weeks after administration
Key secondary outcomes Blood lipids, glucose, HbA1c
Markers indicating obesity (e.g. adiponectin), inflammation (high sensitive CRP), and early-staged kidney diseases (microalbuminuria)
4 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
Medicine
Interventions/Control_1 hydrogen tablet 2tab/day for 4 weeks
>
placebo 2tab/day for 4 weeks
Interventions/Control_2 placebo 2tab/day for 4 weeks
>
hydrogen tablet 2tab/day for 4 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) Patients with cardiovascular diseases, diabetes and dyslipidemia
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 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Ayaori
Organization Tokorozawa Heart Center
Division name Shintokoekimae Clinic
Zip code
Address 1-4-1 Midoricho Tokorozawa Japan 359-1111
TEL 04-2929-1801
Email ayaori@ba2.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Ayaori
Organization Tokorozawa Heart Center
Division name Shintokoekimae Clinic
Zip code
Address 1-4-1 Midoricho Tokorozawa Japan 359-1111
TEL 04-2929-1801
Homepage URL
Email ayaori@ba2.so-net.ne.jp

Sponsor
Institute Tokorozawa Heart Center
Institute
Department

Funding Source
Organization Foundation for Promotion of Defense Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2019 Year 05 Month 24 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
2018 Year 05 Month 16 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 24 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
2018 Year 05 Month 24 Day
Last modified on
2018 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037292

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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