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Name
UMIN ID

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010365
Receipt No. R000012119
Scientific Title The effect of Shiobara hot spring
Date of disclosure of the study information 2013/03/30
Last modified on 2013/03/30

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Basic information
Public title The effect of Shiobara hot spring
Acronym Shiobara Study
Scientific Title The effect of Shiobara hot spring
Scientific Title:Acronym Shiobara Study
Region
Japan

Condition
Condition Dry skin
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of hot spring to the skin condition
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Skin hydration, Trans-epidermal water loss, subjective scale,
Key secondary outcomes

Base
Study type

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Hot spring of Koun-so
Interventions/Control_2 Hot spring of Myoga-ya
Interventions/Control_3 Hot spring of Keiunkaku
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
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Healthy female
Key exclusion criteria Not have skin desease
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasusaki Goto
Organization Japan Health & Research Institute
Division name Onsen medical science research center
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 Onsen medical science research center
Zip code
Address
TEL
Homepage URL
Email ygoto@jph-ri.or.jp

Sponsor
Institute Japan Health & Research Institute
Institute
Department

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
2013 Year 03 Month 30 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 12 Month 15 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 27 Day
Last follow-up date
2013 Year 12 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 03 Month 30 Day
Last modified on
2013 Year 03 Month 30 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012119

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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