UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041757 |
|---|---|
| Receipt number | R000047661 |
| Scientific Title | Effects of Contrast Water Therapy |
| Date of disclosure of the study information | 2020/09/14 |
| Last modified on | 2021/03/12 10:06:51 |
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Basic information
Public title
Effects of Contrast Water Therapy
Acronym
Effects of Contrast Water Therapy
Scientific Title
Effects of Contrast Water Therapy
Scientific Title:Acronym
Effects of Contrast Water Therapy
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to clarify the effect of Contrast Water Therapy on the mind and body.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Saliva oxytocin
Key secondary outcomes
Saliva cortisol, s-IgA, Subjective psychological index
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Hot bathtub bathing, single time
Contrast Water Therapy(CWT), single time
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adult who have consented to participate in the research.
Healthy adult.
Adult who usually take CWT.
Key exclusion criteria
Bathing is prohibited by doctors.
Poor physical condition.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Hayasaka |
Organization
Japan Health & Research Institute
Tokyo City University
Division name
Onsen Medical Science Research Center, Japan Health & Research Institute
Zip code
103-0027
Address
Garou Building 8F 3-1-4 Nihonbashi Cyuou-ku, Tokyo
TEL
03-5290-1621
info@jph-ri.or.jp
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Hayasaka |
Organization
Japan Health & Research Institute
Division name
Onsen Medical Science Research Center, Japan Health & Research Institute
Zip code
103-0027
Address
Garou Building 8F 3-1-4 Nihonbashi Cyuou-ku, Tokyo
TEL
03-5290-1621
Homepage URL
info@jph-ri.or.jp
Sponsor or person
Institute
Japan Health & Research Institute
Institute
Department
Personal name
Funding Source
Organization
SORYUSHA
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2020 | Year | 09 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.32279/jjhr.202142G07
Number of participants that the trial has enrolled
9
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
Main results already published
Date of protocol fixation
| 2020 | Year | 09 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2021 | 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
| 2020 | Year | 09 | Month | 11 | Day |
Last modified on
| 2021 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047661
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
