UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060667 |
|---|---|
| Receipt number | R000069389 |
| Scientific Title | Evaluation of the validity of skin blood flow assessment using a microscope for the cutaneous vasodilatory response to carbonated water immersion |
| Date of disclosure of the study information | 2026/02/13 |
| Last modified on | 2026/02/13 14:48:29 |
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Basic information
Public title
Evaluation of the validity of skin blood flow assessment using a microscope for the cutaneous vasodilatory response to carbonated water immersion
Acronym
Evaluation of the validity of skin blood flow assessment using a microscope for the cutaneous vasodilatory response to carbonated water immersion
Scientific Title
Evaluation of the validity of skin blood flow assessment using a microscope for the cutaneous vasodilatory response to carbonated water immersion
Scientific Title:Acronym
Evaluation of the validity of skin blood flow assessment using a microscope for the cutaneous vasodilatory response to carbonated water immersion
Region
| Japan |
Condition
Condition
heat stroke
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the increase in skin blood flow induced by carbonated water immersion can be evaluated using a microscope.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in skin blood flow induced by carbonated water immersion
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
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Immersion in tap water
Interventions/Control_2
Immersion in low concentration carbonated water
Interventions/Control_3
Immersion in high concentration carbonated water
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
BMI between 18.5 and 30
Key exclusion criteria
Individuals with skin conditions that make measurement difficult at the target site, or individuals for whom measurement of skin blood flow is difficult
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, Junior College
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
| 2026 | Year | 02 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 02 | Month | 13 | Day |
Last modified on
| 2026 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069389
