UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053364 |
|---|---|
| Receipt number | R000060876 |
| Scientific Title | Evaluation of the experience in mist sauna |
| Date of disclosure of the study information | 2024/01/17 |
| Last modified on | 2024/01/16 13:07:35 |
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Basic information
Public title
Evaluation of the experience in mist sauna
Acronym
Evaluation of the experience in mist sauna
Scientific Title
Evaluation of the experience in mist sauna
Scientific Title:Acronym
Evaluation of the experience in mist sauna
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the subjective evaluation of the sensation and evaluating the autonomic nervous system in a real bathing test in a mist sauna.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective physical and mental changes
Key secondary outcomes
autonomic nervous system functions
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
Mist sauna and cold water bath: 3 times on the same day, one day
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
| 20 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male
Key inclusion criteria
Persons who bathe at least once a month in a sauna (including bathing in a water bath), are in good health (no underlying medical conditions, no hospital visits or medication), and have a standard body shape.
Key exclusion criteria
Subjects not meeting selection criteria
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kouki |
| Middle name | |
| Last name | Nagai |
Organization
TOHO GAS CO.,LTD.
Division name
Technical Research Institute
Zip code
456-8511
Address
19-18,Sakurada-cho,Atsuta-ku,Nagoya-shi,Aichi
TEL
052-872-9362
kateiyogijutsu@tohogas.co.jp
Public contact
Name of contact person
| 1st name | Michiyo |
| Middle name | |
| Last name | Morioki |
Organization
TOHO GAS CO.,LTD.
Division name
Technical Research Institute
Zip code
456-8511
Address
19-18,Sakurada-cho,Atsuta-ku,Nagoya-shi,Aichi
TEL
052-872-9362
Homepage URL
kateiyogijutsu@tohogas.co.jp
Sponsor or person
Institute
Technical Research Institute TOHO GAS CO.,LTD.
Institute
Department
Personal name
Funding Source
Organization
TOHO GAS CO.,LTD., Rinnai Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japan Health & Research Institute
Tokyo City University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Health & Research Institute
Address
Garou Building 8F 3-1-4 Nihonbashi Cyuou-ku, Tokyo
Tel
03-5290-1621
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 | 01 | Month | 17 | 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
| 2024 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | 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 | 01 | Month | 16 | Day |
Last modified on
| 2024 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060876
