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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000012357
Receipt No. 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

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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
Institute Japan Health & Research Institute
Institute
Department

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
URL(English) https://upload.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


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