UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042165 |
|---|---|
| Receipt number | R000047440 |
| Scientific Title | Examination of bathing method with high thermal effect on the body |
| Date of disclosure of the study information | 2020/10/19 |
| Last modified on | 2021/10/20 13:25:58 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of bathing method on body temperature and physiological index
Acronym
Effects of bathing method on body temperature and physiological index
Scientific Title
Examination of bathing method with high thermal effect on the body
Scientific Title:Acronym
Examination of bathing method with high thermal effect on the body
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Consider safe bathing conditions from changes in body temperature and physiological indices.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in body temperature while bathing
Key secondary outcomes
Blood pressure
Heart rate
Autonomic nervous activity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Bathing method A
Interventions/Control_2
Bathing method B
Interventions/Control_3
Bathing method C
Interventions/Control_4
Bathing method D
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Key exclusion criteria
1) Serious disorder
2) Person judged be inappropriate by the principal investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Taichi |
| Middle name | |
| Last name | Ishizawa |
Organization
Bathclin Corporation
Division name
Products Development DEPT
Zip code
3050033
Address
29-9 Higashiarai.Tsukuba-shi.Ibaraki-ken.Japan
TEL
+81-29-861-0160
ishizawa_taichi@bathclin.co.jp
Public contact
Name of contact person
| 1st name | taichi |
| Middle name | |
| Last name | Ishizawa |
Organization
Bathclin Corporation
Division name
Products Development DEPT
Zip code
3050033
Address
29-9 Higashiarai.Tsukuba-shi.Ibaraki-ken.Japan
TEL
+81-29-861-0160
Homepage URL
ishizawa_taichi@bathclin.co.jp
Sponsor or person
Institute
Bathclin Corporation
Institute
Department
Personal name
Funding Source
Organization
Bathclin Corporation
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Bathclin Corporation IRB
Address
29-9 Higashiarai.Tsukuba-shi.Ibaraki-ken.Japan
Tel
029-861-0160
ishizawa_taichi@bathclin.co.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
株式会社バスクリン（茨城県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 19 | 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
13
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
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 04 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 04 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 04 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 19 | Day |
Last modified on
| 2021 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047440
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
