UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052978 |
|---|---|
| Receipt number | R000060441 |
| Scientific Title | Physical and mental Effects of hot spring bathing and staying in hot spring areas in Izu |
| Date of disclosure of the study information | 2023/12/03 |
| Last modified on | 2023/12/02 07:05:07 |
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Basic information
Public title
Physical and mental Effects of hot spring bathing and staying in hot spring areas in Izu
Acronym
Physical and mental Effects of hot spring bathing and staying in hot spring areas in Izu
Scientific Title
Physical and mental Effects of hot spring bathing and staying in hot spring areas in Izu
Scientific Title:Acronym
Physical and mental Effects of IZU hot spring
Region
| Japan |
Condition
Condition
healthy volunteers over 20y.o
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of bathing and staying in Izu hot spring area
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective health status
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Bathing and staying at hot springs in the Izu area
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adluts over 18 y.o.
Key exclusion criteria
Those who have diagnosed with the condition that they should not take bathing
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yasuaki |
| Middle name | |
| Last name | Goto |
Organization
Japan Health & Research Institute
Division name
Research Department
Zip code
103-0027
Address
3-1-4, Nihonbashi, Chuo, Tokyo, Japan
TEL
+81-5290-1621
ygoto@jph-ri.or.jp
Public contact
Name of contact person
| 1st name | Yasuaki |
| Middle name | |
| Last name | Goto |
Organization
Japan Health & Research Institute
Division name
Research Department
Zip code
103-0027
Address
3-1-4, Nihonbashi, Chuo, Tokyo, Japan
TEL
+81-3-5290-1621
Homepage URL
ygoto@jph-ri.or.jp
Sponsor or person
Institute
Japan Health & Research Institute
Institute
Department
Personal name
Funding Source
Organization
Shizuoka Prefexture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Health & Research Institute
Address
3-1-4, Nihonbashi, Chuo, Tokyo, Japan
Tel
+81-3-5290-1621
info@jph-ri.or.jp
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
| 2023 | Year | 12 | Month | 03 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 02 | Day |
Last modified on
| 2023 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060441
