UMIN-CTR Clinical Trial

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
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	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
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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048754