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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024413
Receipt No. R000028084
Scientific Title Bathing benefits of Taketa hot springs
Date of disclosure of the study information 2016/10/14
Last modified on 2016/10/14

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Basic information
Public title Bathing benefits of Taketa hot springs
Acronym Taketa hot springs study
Scientific Title Bathing benefits of Taketa hot springs
Scientific Title:Acronym Taketa hot springs study
Region
Japan

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

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

Assessment
Primary outcomes Accelerated photoplethysmography, Heart rate valiability, Salivary amylase, Sublingual temperature, Blood pressure
Key secondary outcomes Skin temperature, Subjective health status

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 7
Purpose of intervention Treatment
Type of intervention
Behavior,custom Other
Interventions/Control_1 A bathing in hot spring of Nagayu area 1
Interventions/Control_2 A bathing in hot spring of Kuju Area
Interventions/Control_3 A bathing in hot spring of Taketa Area
Interventions/Control_4 A bathing in hot spring of Ogi Area
Interventions/Control_5 A bathing in hot tap water
Interventions/Control_6 A bathing in hot spring of Nagayu area 2
Interventions/Control_7 A bathing in hot spring of Kuju Area 2
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Healthy adults
Key exclusion criteria Who can not bathing
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuaki Goto
Organization Japan Health & Research Institute
Division name Onsen Medical Science Research Center
Zip code
Address 1-29-4, Nihonbashikakikara, Chuo
TEL 03-3668-1261
Email ygoto@jph-ri.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuaki Goto
Organization Japan Health & Research Institute
Division name Onsen Medical Science Research Center
Zip code
Address 1-29-4, Nihonbashikakikara, Chuo
TEL 03-3668-1261
Homepage URL
Email ygoto@jph-ri.or.jp

Sponsor
Institute Japan Health & Research Institute
Institute
Department

Funding Source
Organization Taketa city
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 10 Month 14 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
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 Enrolling by invitation
Date of protocol fixation
2016 Year 08 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 14 Day
Last modified on
2016 Year 10 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028084

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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