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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033219
Receipt No. R000037880
Official scientific title of the study A verification study of influence of long term and continuous suction of hydrogen on brain stress, cognitive function and physical function
Date of disclosure of the study information 2018/07/04
Last modified on 2018/07/01

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Basic information
Official scientific title of the study A verification study of influence of long term and continuous suction of hydrogen on brain stress, cognitive function and physical function
Title of the study (Brief title) Influence study of long term hydrogen suctioning on brain stress, cognitive function 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, cognitive function 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 cognitive function
(3)Evaluation of physical function
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
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. At the day of 4, 8 and 12 weeks after start, visit the test place, measuring blood pressure, answer the questionnaire, measuring auto nervous system, measuring central nervous system, MMSE test, olfactory test, locomotion test and pegboard test. During 8 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 as same way as the first term. At the day of 16 and 20 weeks after start, visit the test place and test as same way as the first term.
Interventions/Control_2
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 30

Research contact person
Name of lead principal investigator Yukihiro Yada
Organization University of Tsukuba
School of Integrative
Division name Global Majors
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 Makoto Ichinohe
Organization CPCC Company Limited
Division name Planning & Sales Department
Address 4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL 03-5297-3112
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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 05 Month 15 Day
Anticipated trial start date
2018 Year 07 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 07 Month 01 Day
Last modified on
2018 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037880

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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