UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042715 |
|---|---|
| Receipt number | R000048754 |
| Scientific Title | Examination of the cooling effect of a low-temperature CO2-rich water |
| Date of disclosure of the study information | 2020/12/11 |
| Last modified on | 2022/04/01 16:44:29 |
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Basic information
Public title
Examination of the cooling effect of a low-temperature CO2-rich water
Acronym
Examination of the cooling effect of a low-temperature CO2-rich water
Scientific Title
Examination of the cooling effect of a low-temperature CO2-rich water
Scientific Title:Acronym
Examination of the cooling effect of a low-temperature CO2-rich water
Region
| Japan |
Condition
Condition
heat stroke
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether immersion in a low-temperature CO2-rich water has a greater effect on lowering body temperature than immersion in tap water
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The cooling time and cooling rate at which the raised body temperature returns to its original temperature (before heating) by immersion in a CO2-rich water or tap water
Key secondary outcomes
body temperature
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
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
After the body temperature has been raised by about 1 degree Celsius, whole body water immersion will be conducted. After passive heating, the subjects immersed in 25 degree Celsius CO2-rich water.
Interventions/Control_2
After the body temperature has been raised by about 1 degree Celsius, whole body water immersion will be conducted. After passive heating, the subjects immersed in 25 degree Celsius tap water.
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
| 50 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy male students of the University of Shizuoka and the University of Shizuoka Junior College, who were found to be in good health during the physical examination, and who explained the study content orally and in writing, and who agreed to participate in the measurement.
Key exclusion criteria
Those who do not conform to the incluson criteria.
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
Junior College, University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The research ethics committee of the 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
| 2020 | Year | 12 | Month | 11 | 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
12
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
| 2020 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2022 | 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
| 2020 | Year | 12 | Month | 10 | Day |
Last modified on
| 2022 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048754
