UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010365 |
|---|---|
| Receipt number | 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 10:15:53 |
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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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012119
