UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on body temperature change in bathing
Title of the study (Brief title)	Study on body temperature change in bathing
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Confirm body temperature change by age
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Body temperature change after bathing
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	I analyze a temperature change of the bathing according to age
Interventions/Control_2
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	20 years-old <=
Age-upper limit	69 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy males and females
Key exclusion criteria	1)Serious disorder 2)Indivduals who judged the person in charge of the examination is inappropriate
Target sample size	60

Research contact person
Name of lead principal investigator	Taichi Ishizawa
Organization	Bathclin Corporation
Division name	Products Development DEPT
Address	29-9,Higashiarai,Tsukuba-shi,Ibaraki-ken,305-0033,Japan
TEL	+81-29-861-0160
Email	ishizawa_taichi@bathclin.co.jp

Public contact
Name of contact person	Taichi Ishizawa
Organization	Bathclin Corporation
Division name	Products Development DEPT
Address	29-9,Higashiarai,Tsukuba-shi,Ibaraki-ken,305-0033,Japan
TEL	+81-29-861-0160
Homepage URL
Email	ishizawa_taichi@bathclin.co.jp

Sponsor
Institute	Bathclin Corporation
Institute
Department

Funding Source
Organization	Bathclin Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Shubun University Laboratory of HSP Research Project
Name of secondary funｄer(s)

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	株式会社バスクリン（茨城県）

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 22 Day
Anticipated trial start date	2015 Year 06 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results	http://www.onsen-msrc.com/research/files/report39_02.pdf
Results
Other related information

Management information
Registered date	2017 Year 12 Month 25 Day
Last modified on	2018 Year 06 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034879