UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033220 |
|---|---|
| Receipt number | R000037881 |
| Scientific Title | A verification study of influence of long term and continuous suction of hydrogen on brain stress and physical function |
| Date of disclosure of the study information | 2018/07/04 |
| Last modified on | 2019/07/03 11:29:35 |
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Basic information
Public title
A verification study of influence of long term and continuous suction of hydrogen on brain stress and physical function
Acronym
Influence study of long term hydrogen suctioning on brain stress and physical function
Scientific Title
A verification study of influence of long term and continuous suction of hydrogen on brain stress and physical function
Scientific Title:Acronym
Influence study of long term hydrogen suctioning on brain stress and physical function
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the influence of long term continuous suction of hydrogen on brain stress and physical function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1)Evaluation of brain stress
(2)Evaluation of physical function
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
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
During 12 weeks of the first term, 5 times a day (for examples wake up, after breakfast, after lunch, after dinner and before bed time), 5 minute suction of hydrogen at once for 6 to 12 weeks after start. At the day of 6 and 12 weeks after start, visit the test place, measuring blood pressure, answer the questionnaire, measuring auto nervous system, measuring central nervous system and locomotion test. During 12 weeks of the second term which is designed against the subjects who will accept to continue the test at the 12 weeks after start, suction hydrogen for 12 to 24 weeks after start as same way as the first term. At the day of 16, 20 and 24 weeks after start, visit the test place and test as same way as the first term.
Interventions/Control_2
During 12 weeks of the first term, 5 times a day (for examples wake up, after breakfast, after lunch, after dinner and before bed time), 5 minute suction of hydrogen at once for 6 to 12 weeks after start. At the day of 0 and 6 weeks after start, visit the test place, measuring blood pressure, answer the questionnaire, measuring auto nervous system, measuring central nervous system and locomotion test. During 12 weeks of the second term which is designed against the subjects who will accept to continue the test at the 12 weeks after start, suction hydrogen for 12 to 24 weeks after start as same way as the first term. At the day of 16, 20 and 24 weeks after start, visit the test place and test as same way as the first term.
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Male and Females aged over 30 years old when informed consent.
(2) Subjects who show understanding of the clinical study procedures and agreement with participating the study by written informed consent prior to the study.
Key exclusion criteria
(1)Subjects who have been determined ineligible by the investigator of this clinical test.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukihiro Yada |
Organization
University of Tsukuba
School of Integrative
Division name
Global Majors
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki 305-8577 Japan
TEL
029-853-7344
yada.yukihiri.gb@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Ichinohe |
Organization
CPCC Company Limited
Division name
Planning & Sales Department
Zip code
Address
4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
0352975548
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
University of Tsukuba
School of Integrative
Institute
Department
Personal name
Funding Source
Organization
Aqua Bank Co., Ltd
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
Address
Tel
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
| 2018 | Year | 07 | Month | 04 | 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
| 2018 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 01 | Day |
Last modified on
| 2019 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037881
