UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012357
Receipt number R000014446
Scientific Title The effect of Tsukioka hot spring
Date of disclosure of the study information 2013/11/20
Last modified on 2014/09/04 09:05:45

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The effect of Tsukioka hot spring

Acronym

Tsukioka study

Scientific Title

The effect of Tsukioka hot spring

Scientific Title:Acronym

Tsukioka study

Region

Japan


Condition

Condition

Stress

Classification by specialty

Medicine in general Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the physical and mental effects of hot spring

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

salivary amylase, subjective scale

Key secondary outcomes



Base

Study type


Study design

Basic design

Cross-over

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

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

bathing in Tsukioka hot spring

Interventions/Control_2

bathing in tap water

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

Female

Key inclusion criteria

Healthy female

Key exclusion criteria

Not have skin desease

Target sample size

20


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 Nihombashi-Kakikara Chuo Tokyo

TEL

+81-3-3668-1261

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 Nihombashi-Kakikara Chuo Tokyo

TEL

+81-3-3668-1261

Homepage URL


Email

ygoto@jph-ri.or.jp


Sponsor or person

Institute

Japan Health & Research Institute

Institute

Department

Personal name



Funding Source

Organization

Tsukioka Onsen tourist association

Organization

Division

Category of Funding Organization

Other

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

2013 Year 11 Month 20 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

2013 Year 08 Month 20 Day

Date of IRB


Anticipated trial start date

2013 Year 11 Month 21 Day

Last follow-up date

2014 Year 03 Month 29 Day

Date of closure to data entry

2014 Year 03 Month 29 Day

Date trial data considered complete

2014 Year 03 Month 29 Day

Date analysis concluded

2014 Year 03 Month 29 Day


Other

Other related information



Management information

Registered date

2013 Year 11 Month 20 Day

Last modified on

2014 Year 09 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014446


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name