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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000042165
Receipt No. R000047440
Scientific Title Examination of bathing method with high thermal effect on the body
Date of disclosure of the study information 2020/10/19
Last modified on 2020/10/19

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Basic information
Public title Effects of bathing method on body temperature and physiological index
Acronym Effects of bathing method on body temperature and physiological index
Scientific Title Examination of bathing method with high thermal effect on the body
Scientific Title:Acronym Examination of bathing method with high thermal effect on the body
Region
Japan

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

Objectives
Narrative objectives1 Consider safe bathing conditions from changes in body temperature and physiological indices.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Changes in body temperature while bathing
Key secondary outcomes Blood pressure
Heart rate
Autonomic nervous activity

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 4
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Bathing method A
Interventions/Control_2 Bathing method B
Interventions/Control_3 Bathing method C
Interventions/Control_4 Bathing method D
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
65 years-old >
Gender Male and Female
Key inclusion criteria Healthy adults
Key exclusion criteria 1) Serious disorder
2) Person judged be inappropriate by the principal investigator
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Taichi
Middle name
Last name Ishizawa
Organization Bathclin Corporation
Division name Products Development DEPT
Zip code 3050033
Address 29-9 Higashiarai.Tsukuba-shi.Ibaraki-ken.Japan
TEL +81-29-861-0160
Email ishizawa_taichi@bathclin.co.jp

Public contact
Name of contact person
1st name taichi
Middle name
Last name Ishizawa
Organization Bathclin Corporation
Division name Products Development DEPT
Zip code 3050033
Address 29-9 Higashiarai.Tsukuba-shi.Ibaraki-ken.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 Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Bathclin Corporation IRB
Address 29-9 Higashiarai.Tsukuba-shi.Ibaraki-ken.Japan
Tel 029-861-0160
Email ishizawa_taichi@bathclin.co.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 株式会社バスクリン(茨城県)

Other administrative information
Date of disclosure of the study information
2020 Year 10 Month 19 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 13
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
2020 Year 08 Month 24 Day
Date of IRB
2020 Year 08 Month 24 Day
Anticipated trial start date
2020 Year 10 Month 19 Day
Last follow-up date
2021 Year 03 Month 01 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 10 Month 19 Day
Last modified on
2020 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047440

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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