UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054586 |
|---|---|
| Receipt number | R000062375 |
| Scientific Title | A pilot study to confirm changes in cerebral blood flow caused by hydrogen inhalation |
| Date of disclosure of the study information | 2024/06/22 |
| Last modified on | 2024/11/26 15:41:45 |
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Basic information
Public title
A pilot study to confirm changes in cerebral blood flow caused by hydrogen inhalation
Acronym
A pilot study to confirm changes in cerebral blood flow caused by hydrogen inhalation
Scientific Title
A pilot study to confirm changes in cerebral blood flow caused by hydrogen inhalation
Scientific Title:Acronym
A pilot study to confirm changes in cerebral blood flow caused by hydrogen inhalation
Region
| Japan |
Condition
Condition
Healty volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm changes in cerebral blood flow caused by hydrogen inhalation using a home device that generates hydrogen gas
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NIRS-TRS
Key secondary outcomes
Wearable Heart rate Sensor,blood flow microscope
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
Before and after comparison
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Japanese Male and female.Aged over 20 years of age and less than 75 years of age.
2) Subjects who voluntarily wish to participate in the clinical trial and provide written consent.
3) Subjects who able to maintain a consistent daily lifestyle during the study period.
Key exclusion criteria
1) Subjects with serious diseases (diabetes, heart disease, cancer, etc.) or mental illness.
2) Subjects with a history of serious diseases (diabetes, heart disease, liver disease, renal disease, cancer, etc.) in the past.
3) Subjects who have symptoms of severe anemia.
4) Subjects who are unable to maintain their daily lifestyle due to significant changes in diet and physical activity.
5) pregnant women , breast-feeding women , and hopes for the pregnancy during an examination.
6) Subjects who are otherwise ineligible for participation in this study by the investigater.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Den |
Organization
CNB Medical Research Institute Co., Ltd.
Division name
Representative director
Zip code
1410031
Address
2-29-11-5F Nishigotanda, Shinagawa-ku, Tokyo
TEL
03-6426-8768
angus.tin@cnb.co.jp
Public contact
Name of contact person
| 1st name | Tatsuo |
| Middle name | |
| Last name | Uetake |
Organization
CXwellness, Inc.
Division name
Representative Director
Zip code
1730004
Address
2-63-9-401 Itabashi, Itabashi-ku, Tokyo
TEL
03-6915-5507
Homepage URL
uetake@cx-wellness.com
Sponsor or person
Institute
CXwellness, Inc.
Institute
Department
Personal name
Funding Source
Organization
CNB Medical Research Institute 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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo
Tel
03-6240-1162
info@ueno-asagao.clinic
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
| 2024 | Year | 06 | Month | 22 | 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
15
Results
Using TRS-NIRS, we demonstrated that hydrogen inhalation caused significant changes in cerebral hemodynamics. The asymmetric change in HbO2 between the right and left prefrontal cortex suggested that hydrogen inhalation may selectively affect cerebral hemodynamics.
Results date posted
| 2024 | Year | 11 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
No adverse events were observed.
Outcome measures
NIRS-TRS
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 06 | Day |
Last modified on
| 2024 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062375
