UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051588 |
|---|---|
| Receipt number | R000058858 |
| Scientific Title | Research on the effect of hydrogen gas inhalation on oxidized lipids |
| Date of disclosure of the study information | 2023/07/13 |
| Last modified on | 2023/11/13 23:34:51 |
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Basic information
Public title
Research on the effect of hydrogen gas inhalation on oxidized lipids
Acronym
Research on the effect of hydrogen gas inhalation on oxidized lipids
Scientific Title
Research on the effect of hydrogen gas inhalation on oxidized lipids
Scientific Title:Acronym
Research on the effect of hydrogen gas inhalation on oxidized lipids
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effect of hydrogen gas on oxidized lipid production.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Volatile organic compounds (VOC) in exhaled gas involved in hydrogen gas
Key secondary outcomes
(1) Blood cells, lactate level, blood sugar, renal function, liver function, cytokines in blood, and metabolite profile obtained from plasma metabolome analysis involved in hydrogen gas
(2) Changes in blood pressure, pulse rate, and heart rate involved in hydrogen gas
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Inhalation of hydrogen gas for 30 minutes by nasal airway using a hydrogen inhaler
Interventions/Control_2
Inhalation of atmospheric gases via nasal airway for 30 minutes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Healthy adults over 18 years old
Key exclusion criteria
1. Subjects who have difficulty wearing a mask for 15 minutes at rest
2.Those who are judged to be inappropriate as subjects of this research by the research director/co-investigator
3.Subjects who take medicine on a daily life
4.Subjects with dementia or mental illness who cannot understand the significance of this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Katsumata |
| Middle name | |
| Last name | Yoshinori |
Organization
Keio University
Division name
School of Medicine, Institute for Integrated Sports Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan
TEL
03-5269-9054
goodcentury21@keio.jp
Public contact
Name of contact person
| 1st name | Katsumata |
| Middle name | |
| Last name | Yoshinori |
Organization
Keio University
Division name
School of Medicine, Institute for Integrated Sports Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan
TEL
03-5269-9054
Homepage URL
goodcentury21@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Doctors Man Co., Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan
Tel
03-5363-3503
med-rinri-jimu@adst.keio.ac.jp
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
| 2023 | Year | 07 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2023 | Year | 07 | Month | 12 | Day |
Last modified on
| 2023 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058858
