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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036176
Receipt No. R000041214
Scientific Title Examination of cooling effect by low temperature carbon dioxide water
Date of disclosure of the study information 2019/03/13
Last modified on 2019/09/11

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Basic information
Public title Examination of cooling effect by low temperature carbon dioxide water
Acronym Examination of cooling effect by carbon dioxide water
Scientific Title Examination of cooling effect by low temperature carbon dioxide water
Scientific Title:Acronym Examination of cooling effect by carbon dioxide 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 carbonated spring 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 Immarsion in carbonated water or tap water
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 9

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 Junior College, University of Shizuoka
Institute
Department

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
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
2019 Year 03 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 9
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 No longer recruiting
Date of protocol fixation
2018 Year 12 Month 03 Day
Date of IRB
2018 Year 12 Month 03 Day
Anticipated trial start date
2019 Year 03 Month 01 Day
Last follow-up date
2020 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 03 Month 12 Day
Last modified on
2019 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041214

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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