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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046193
Receipt No. 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 2021/11/26

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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
Email 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
Email khayashi@u-shizuoka-ken.ac.jp

Sponsor
Institute University of Shizuoka
Institute
Department

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
Email 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 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
2021 Year 10 Month 22 Day
Date of IRB
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
2021 Year 11 Month 26 Day


Link to view the page
URL(English) 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
Registered date File name

Research case data
Registered date File name


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