UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038971 |
|---|---|
| Receipt number | R000044446 |
| Scientific Title | Examination of cooling effect by low density CO2 water |
| Date of disclosure of the study information | 2019/12/25 |
| Last modified on | 2020/12/10 15:28:18 |
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Basic information
Public title
Examination of cooling effect by low density CO2 water
Acronym
Examination of cooling effect by CO2 water
Scientific Title
Examination of cooling effect by low density CO2 water
Scientific Title:Acronym
Examination of cooling effect by CO2 water
Region
| Japan |
Condition
Condition
heat stroke
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether cooling using low density CO2 water is more effective than cooling using tap water
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
decrease rate in body temperature
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
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
CO2 water immersion and tap water immersion
Interventions/Control_2
About 1 degrees C rise in body temperature
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
| Not applicable |
Gender
Male
Key inclusion criteria
There is no menstrual cycle
Key exclusion criteria
Person who had abnormality in medical 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
Junior College, University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
JSPS
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
054-264-5102
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
| 2019 | Year | 12 | Month | 25 | 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
10
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 | 10 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2021 | 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
| 2019 | Year | 12 | Month | 24 | Day |
Last modified on
| 2020 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044446
