UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053531 |
|---|---|
| Receipt number | R000061092 |
| Scientific Title | Project to investigate the refreshing effects of Yaizu hot spring |
| Date of disclosure of the study information | 2024/02/03 |
| Last modified on | 2024/02/03 17:28:00 |
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Basic information
Public title
Project to investigate the refreshing effects of Yaizu hot spring
Acronym
Project to investigate the refreshing effects of Yaizu hot spring
Scientific Title
Project to investigate the refreshing effects of Yaizu hot spring
Scientific Title:Acronym
Project to investigate the refreshing effects of Yaizu hot spring
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the refreshing effects of Yaizu hot spring
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS (fatigue)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Bathe in hot spring water for 3 days -> Washout period -> Bathe in boiling tap water for 3 days
Interventions/Control_2
Bathe in boiling tap water for 3 days -> Washout period -> Bathe in hot spring water for 3 days
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) At informed consent, male/female subjects aged more than or equal to 18, and less than or equal to 80 years old.
(2) Subjects who can show their understanding of the study procedure and agreement with participating in the study by informed consent prior to the study.
Key exclusion criteria
(1) Subject who are prohibited from taking a bath by a doctor
(2) Subject who cannot bathe by themselves
(3) Others who have been determined ineligible by the principal investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Shinnosuke |
| Middle name | |
| Last name | Murakami |
Organization
Metagen, Inc.
Division name
Headquarters
Zip code
997-0052
Address
246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL
+81-235-64-0330
research@metagen.co.jp
Public contact
Name of contact person
| 1st name | Yasuaki |
| Middle name | |
| Last name | Goto |
Organization
Japan Health and Research Institute
Division name
Research Depertment
Zip code
103-0027
Address
3-1-4 Nihonbashi Chuo, Tokyo
TEL
+81-3-5290-1621
Homepage URL
ygoto@jph-ri.or.jp
Sponsor or person
Institute
Metagen, Inc.
Institute
Department
Personal name
Funding Source
Organization
Yaizu City
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 and Research Institute
Address
3-1-4 Nihonbashi Chuo, Tokyo
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
| 2024 | Year | 02 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2024 | Year | 02 | 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
| 2024 | Year | 02 | Month | 03 | Day |
Last modified on
| 2024 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061092
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
