UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056426 |
|---|---|
| Receipt number | R000064480 |
| Scientific Title | Physical and mental effects of TOUJI retreat program |
| Date of disclosure of the study information | 2024/12/11 |
| Last modified on | 2024/12/11 18:13:05 |
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Basic information
Public title
Physical and mental effects of TOUJI retreat program
Acronym
TOUJI retreat program
Scientific Title
Physical and mental effects of TOUJI retreat program
Scientific Title:Acronym
TOUJI retreat program
Region
| Japan |
Condition
Condition
Lifestyle-related diseases
Classification by specialty
| Medicine in general | Psychosomatic Internal Medicine | Geriatrics |
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the impact of the Touji Stay Retreat Program on the body and mind.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Subjective health status
Key secondary outcomes
Accelerated photoplethysmography, Heart rate valiability, Salivary amylase, Blood pressure, Flexibility
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
The retreat program through Touji Stay
Interventions/Control_2
Control
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who have given consent to participate in the research
Key exclusion criteria
Exclude those who are prohibited from bathing by a doctor
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Shizuka |
| Middle name | |
| Last name | Kanno |
Organization
TOJI Gurashi
Division name
President
Zip code
874-0840
Address
401-1, Tsurumi Beppu City, Oita
TEL
090-3287-5380
kanno@toji-gurashi.jp
Public contact
Name of contact person
| 1st name | Shizuka |
| Middle name | |
| Last name | Kanno |
Organization
TOUJI Gurashi
Division name
President
Zip code
804-0840
Address
401-1, Tsurumi Beppu City, Oita
TEL
090-3287-5380
Homepage URL
kanno@toji-gurashi.jp
Sponsor or person
Institute
Toji Gurashi
Institute
Department
Personal name
Funding Source
Organization
Ministy of Environment, Oita Pref.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan HEalt & Research Institute
Address
3-1-4, Nihonbashi Chuo-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 | 12 | Month | 11 | 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 | 11 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2029 | 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
| 2024 | Year | 12 | Month | 11 | Day |
Last modified on
| 2024 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064480
