UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009006
Receipt number R000010568
Scientific Title Effects of bathing in Japanese style and shower 2
Date of disclosure of the study information 2012/09/29
Last modified on 2012/09/29 11:31:32

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Basic information

Public title

Effects of bathing in Japanese style and shower 2

Acronym

Japanese bathing RCT2

Scientific Title

Effects of bathing in Japanese style and shower 2

Scientific Title:Acronym

Japanese bathing RCT2

Region

Japan


Condition

Condition

healthy volunteers

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To compare the effect of bathing in Japanese stye and shower

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase



Assessment

Primary outcomes

EEG, RNA, Subjective reported health, SF-8, POMS, PSQI, Smile scale

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

bathing in hot tub (2weeks)

Interventions/Control_2

taking shower (2weeks)

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

59 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy adlut over 30 y.o.

Key exclusion criteria

Those who have diagnosed with the condition that they should not take bathing

Target sample size

12


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuaki Goto

Organization

Japan Health & Research Institute,
Onsen Medical Science Research Center

Division name

Research Department

Zip code


Address

1-29-4 Nihombashi-Kakikara Chuo Tokyo

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Japan Health & Research Institute

Division name

Research Department

Zip code


Address


TEL


Homepage URL


Email

ygoto@jph-ri.or.jp


Sponsor or person

Institute

Japan Health & Research Institute

Institute

Department

Personal name



Funding Source

Organization

Japan Health & Research Institute

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


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

2012 Year 09 Month 29 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

No longer recruiting

Date of protocol fixation

2012 Year 07 Month 26 Day

Date of IRB


Anticipated trial start date

2012 Year 09 Month 01 Day

Last follow-up date

2012 Year 10 Month 14 Day

Date of closure to data entry

2012 Year 11 Month 15 Day

Date trial data considered complete

2012 Year 11 Month 20 Day

Date analysis concluded

2012 Year 12 Month 10 Day


Other

Other related information



Management information

Registered date

2012 Year 09 Month 29 Day

Last modified on

2012 Year 09 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010568


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name