UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037607 |
|---|---|
| Receipt number | R000042883 |
| Scientific Title | Study of thermal comfortable with local cooling method under heat environment. |
| Date of disclosure of the study information | 2019/09/10 |
| Last modified on | 2023/08/09 11:24:28 |
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Basic information
Public title
Study of thermal comfortable with body cooling under hot environment
Acronym
Study of bdoy cooling and thermal comfortable
Scientific Title
Study of thermal comfortable with local cooling method under heat environment.
Scientific Title:Acronym
Local cooling and comfortable
Region
| Japan |
Condition
Condition
Healthy University students
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the effect of local back coolings under heat environment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
local sweating volume, heart rate, thermal comfortable sensation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
control(non-cooling)
Interventions/Control_2
cooling
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
| 24 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Health university students
Key exclusion criteria
medical histry person
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | tanaka |
| Middle name | |
| Last name | hideto |
Organization
Yokohama National University
Division name
Faculty of Education
Zip code
2408501
Address
Hodogaya-ku Tokiwadai,79-1. Yokohama Japan
TEL
0453393075
tanaka-hideto-ht@ynu.ac.jp
Public contact
Name of contact person
| 1st name | tanaka |
| Middle name | |
| Last name | hideto |
Organization
Yokohama National University
Division name
Faculty of Education
Zip code
2408501
Address
Hodogaya-ku Tokiwadai 79-1, Yokohama Japan
TEL
0453393075
Homepage URL
tanaka-hideto-ht@ynu.ac.jp
Sponsor or person
Institute
Yokohama National University
Faculty of Education
Institute
Department
Personal name
Funding Source
Organization
Sony
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
Yokohama National University
Address
Hodogaya-ku tokiwadai 79-1, Yokohama Japan
Tel
0453393075
tanaka-hideto-ht@ynu.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
| 2019 | Year | 09 | Month | 10 | 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
Completed
Date of protocol fixation
| 2019 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 06 | Day |
Last modified on
| 2023 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042883
