UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036250 |
|---|---|
| Receipt number | R000041291 |
| Scientific Title | Change of hydrogen concentration in breath by H2 supplementation |
| Date of disclosure of the study information | 2019/03/19 |
| Last modified on | 2019/04/02 09:56:14 |
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Basic information
Public title
Change of hydrogen concentration in breath by H2 supplementation
Acronym
Change of hydrogen concentration in breath by H2 supplementation
Scientific Title
Change of hydrogen concentration in breath by H2 supplementation
Scientific Title:Acronym
Change of hydrogen concentration in breath by H2 supplementation
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate hydrogen concentration in breath by H2 supplementation
Basic objectives2
Others
Basic objectives -Others
To investigate change of hydrogen concentration in breath by H2 supplementation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
hydrogen concentration in breath
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
dietary supplementation of super H2
Interventions/Control_2
Drinking hydrogen water
Interventions/Control_3
Drinking water
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy
Key exclusion criteria
people who have any diseases under-treatment
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Motoko |
| Middle name | |
| Last name | Kawashima |
Organization
Haneginomori Eye Clinic
Division name
Opthalmology
Zip code
1550033
Address
4 Chome-26-4 Daita, Setagaya City, Tokyo
TEL
03-6265-8777
motoko326@gmail.com
Public contact
Name of contact person
| 1st name | Motoko |
| Middle name | |
| Last name | Kawashima |
Organization
Haneginiomori Eye Clinic
Division name
Opthalmology
Zip code
1530033
Address
4 Chome-26-4 Daita, Setagaya City, Tokyo
TEL
03-6265-8777
Homepage URL
motoko326@gmail.com
Sponsor or person
Institute
Haneginomori Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
Tsubota laboratory Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Review Board of Haneginomori Eye Clinic
Address
4 Chome-26-4 Daita, Setagaya City, Tokyo
Tel
03-6265-8777
mail@hanegi-eye.com
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 | 03 | Month | 19 | 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
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 19 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 19 | Day |
Last modified on
| 2019 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041291
