UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046193 |
|---|---|
| Receipt number | R000052719 |
| Scientific Title | Effects of changes in water temperature on cutaneous vasodilation during immersion in carbonated water |
| Date of disclosure of the study information | 2021/11/26 |
| Last modified on | 2022/11/28 18:18:09 |
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Basic information
Public title
Effects of changes in water temperature on cutaneous vasodilation during immersion in carbonated water
Acronym
Effects of changes in water temperature on cutaneous vasodilation during immersion in carbonated water
Scientific Title
Effects of changes in water temperature on cutaneous vasodilation during immersion in carbonated water
Scientific Title:Acronym
Effects of changes in water temperature on cutaneous vasodilation during immersion in carbonated water
Region
| Japan |
Condition
Condition
heat stroke
Classification by specialty
| Dermatology | Emergency medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify how skin blood flow changes with water temperature and carbonated water concentration.
Basic objectives2
Others
Basic objectives -Others
Evaluate the change in skin blood flow when water temperature and carbonated water concentration are changed.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in skin blood flow with changes in water temperature and carbonated water concentration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Set the water temperature to 25 degrees Celcius and 40 degrees Celcius.
Interventions/Control_2
Dissolve CO2 in the tap water and gradually increase the concentration of carbonated water. The concentration of carbonated water is increased to about 1000 ppm.
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy individuals who have not shown any abnormalities in their physical examination.
Key exclusion criteria
Those with abnormal findings in the health examination.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Keiji |
| Middle name | |
| Last name | Hayashi |
Organization
University of Shizuoka
Division name
Junior College
Zip code
422-8021
Address
2-2-1 Oshika, Suruga-ku, Shizuoka
TEL
054-202-2639
khayashi@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | Keiji |
| Middle name | |
| Last name | Hayashi |
Organization
University of Shizuoka
Division name
Junior College
Zip code
422-8021
Address
2-2-1 Oshika, Suruga-ku, Shizuoka
TEL
054-202-2639
Homepage URL
khayashi@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
University of Shizuoka
Address
52-1 Yada, Suruga-ku, Shizuoka
Tel
054-264-5103
rinri@u-shizuoka-ken.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
| 2021 | Year | 11 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
14
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
| 2021 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2021 | Year | 11 | Month | 26 | Day |
Last modified on
| 2022 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052719
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
