UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024413
Receipt number 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 10:17:40

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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 or person

Institute

Japan Health & Research Institute

Institute

Department

Personal name



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

Value
https://center6.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