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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032741
Receipt No. R000037341
Scientific Title A verification study of influence for cognitive and physical functions by suction of hydrogen four consecutive weeks
Date of disclosure of the study information 2018/05/30
Last modified on 2018/11/26

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Basic information
Public title A verification study of influence for cognitive and physical functions by suction of hydrogen four consecutive weeks
Acronym A verification study of influence for cognitive and physical functions by suction of hydrogen four consecutive weeks
Scientific Title A verification study of influence for cognitive and physical functions by suction of hydrogen four consecutive weeks
Scientific Title:Acronym A verification study of influence for cognitive and physical functions by suction of hydrogen four consecutive weeks
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 on cognitive and body functions by hydrogen suction for four consecutive weeks.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes (1)Evaluation of cognitive function
(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 4 weeks of 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. Then visit the clinic, answer the questionnaire and take MMSE-J, measurement of central nervous system and physical functions, and olfactory test. During 4 weeks of second term, no suction of hydrogen. Then visit the clinic, answer the questionnaire and take MMSE-J, measurement of central nervous system and physical functions, and olfactory test.
Interventions/Control_2 During 4 weeks of first term, no suction of hydrogen. Then visit the clinic, answer the questionnaire and take MMSE-J, measurement of central nervous system and physical functions, and olfactory test. During 4 weeks of second 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. Then visit the clinic, answer the questionnaire and take MMSE-J, measurement of central nervous system and physical functions, and olfactory test.
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Male and Females aged over 40 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 100

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
Email 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 03-5927-3112
Homepage URL
Email cpcc-contact@cpcc.co.jp

Sponsor
Institute University of Tsukuba
School of Integrative
Institute
Department

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
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
2018 Year 05 Month 30 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 04 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 31 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 28 Day
Last modified on
2018 Year 11 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037341

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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