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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035463
Receipt No. R000040371
Official scientific title of the study Bathing effects of Kaneyama Carbonated spring
Date of disclosure of the study information 2019/01/07
Last modified on 2019/01/06

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Basic information
Official scientific title of the study Bathing effects of Kaneyama Carbonated spring
Title of the study (Brief title) Kaneyama Carbonated spring Study
Region
Japan

Condition
Condition Lifestyle disease
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Neurology Geriatrics Rehabilitation medicine
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of bathing in Kaneyama carbonated hot springs
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood pressure
Key secondary outcomes Accelerated photoplethysmography, Heart rate valiability, Sublingual temperature, Motor function, Weight

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom Other
Interventions/Control_1 7days bathing in Carbonated hot spring, 40celcius-10min.
Interventions/Control_2 7days bathing in tap water, 40celcius-10min.
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
30 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Adults
Key exclusion criteria Who can not bathing
Target sample size 20

Research contact person
Name of lead principal investigator Yasuaki Goto
Organization Japan Health & Research Institute
Division name Health Tourism Institute
Address 3-1-4, Nihonbashi Chuo-ku Tokyo Japan
TEL +81-3-5290-1625
Email y_goto422@j-medical-healthcare.com

Public contact
Name of contact person Yasuaki Goto
Organization Japan Health & Research Institute
Division name Health Tourism Institute
Address 3-1-4, Nihonbashi Chuo-ku Tokyo Japan
TEL +81-3-5290-1625
Homepage URL
Email y_goto422@j-medical-healthcare.com

Sponsor
Institute Japan Health & Research Institute
Institute
Department

Funding Source
Organization Kaneyama town
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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 せせらぎ荘

Other administrative information
Date of disclosure of the study information
2019 Year 01 Month 07 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 12 Month 01 Day
Anticipated trial start date
2018 Year 12 Month 01 Day
Last follow-up date
2018 Year 12 Month 28 Day
Date of closure to data entry
2019 Year 02 Month 15 Day
Date trial data considered complete
2019 Year 02 Month 15 Day
Date analysis concluded
2019 Year 12 Month 28 Day

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2019 Year 01 Month 06 Day
Last modified on
2019 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040371

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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