UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Bathing benefits of Taketa hot springs
Title of the study (Brief title)	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	Yasuaki Goto
Organization	Japan Health & Research Institute
Division name	Onsen Medical Science Research Center
Address	1-29-4, Nihonbashikakikara, Chuo
TEL	03-3668-1261
Email	ygoto@jph-ri.or.jp

Public contact
Name of contact person	Yasuaki Goto
Organization	Japan Health & Research Institute
Division name	Onsen Medical Science Research Center
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 08 Month 25 Day
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

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Publication of results	Unpublished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