UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035463 |
|---|---|
| Receipt number | R000040371 |
| Scientific Title | Bathing effects of Kaneyama Carbonated spring |
| Date of disclosure of the study information | 2019/01/07 |
| Last modified on | 2019/01/06 18:11:54 |
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Basic information
Public title
Bathing effects of Kaneyama Carbonated spring
Acronym
Kaneyama Carbonated spring Study
Scientific Title
Bathing effects of Kaneyama Carbonated spring
Scientific Title:Acronym
Kaneyama Carbonated spring Study
Region
| Japan |
Condition
Condition
Lifestyle disease
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Neurology | Geriatrics | Rehabilitation medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of bathing in Kaneyama carbonated hot springs
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure
Key secondary outcomes
Accelerated photoplethysmography, Heart rate valiability, Sublingual temperature, Motor function, Weight
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
7days bathing in Carbonated hot spring, 40celcius-10min.
Interventions/Control_2
7days bathing in tap water, 40celcius-10min.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adults
Key exclusion criteria
Who can not bathing
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
Health Tourism Institute
Zip code
Address
3-1-4, Nihonbashi Chuo-ku Tokyo Japan
TEL
+81-3-5290-1625
y_goto422@j-medical-healthcare.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuaki Goto |
Organization
Japan Health & Research Institute
Division name
Health Tourism Institute
Zip code
Address
3-1-4, Nihonbashi Chuo-ku Tokyo Japan
TEL
+81-3-5290-1625
Homepage URL
y_goto422@j-medical-healthcare.com
Sponsor or person
Institute
Japan Health & Research Institute
Institute
Department
Personal name
Funding Source
Organization
Kaneyama town
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
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
せせらぎ荘
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
| 2019 | Year | 02 | Month | 15 | Day |
Date trial data considered complete
| 2019 | Year | 02 | Month | 15 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 06 | Day |
Last modified on
| 2019 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040371
