UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036176
Receipt number 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 2019/12/24 14:02:14

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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 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

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

Completed

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 12 Month 24 Day



Link to view the page

Value
https://center6.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