UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037645 |
|---|---|
| Receipt number | R000042929 |
| Scientific Title | Evaluation of the efficacy of carbonated water hand bath |
| Date of disclosure of the study information | 2019/10/26 |
| Last modified on | 2019/08/09 11:41:46 |
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Basic information
Public title
Evaluation of the efficacy of carbonated water hand bath
Acronym
Evaluation of the efficacy of carbonated water hand bath
Scientific Title
Evaluation of the efficacy of carbonated water hand bath
Scientific Title:Acronym
Evaluation of the efficacy of carbonated water hand bath
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of percutaneous administration of carbonated water on skin blood circulation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood flow
Key secondary outcomes
Deep body temperature, blood pressure, pulse rate
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The hand is soaked in carbonated water made in Kirin Holdings Company at 20 degrees Celsius for 15 minutes.
Interventions/Control_2
The hand is soaked in carbonated water on the market at 20 degrees Celsius for 15 minutes.
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
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Male and female subjects aged 20-29 years old who give written informed consent
(2) Give written informed consent after receiving sufficient explanation of the study purpose and details, thoroughly understand the study, and of their own free decide to participate
Key exclusion criteria
(1) Have a disease that they cannot soak their hand in water
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masaharu |
| Middle name | |
| Last name | Maeda |
Organization
International University of Health and Welfare
Division name
Department of Occupational Therapy, School of Health Sciences
Zip code
324-8501
Address
2600-1, Kitakanemaru, Ohtawara City, Tochigi, Japan
TEL
090-8000-8207
mm@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Masaharu |
| Middle name | |
| Last name | Maeda |
Organization
International University of Health and Welfare
Division name
Department of Occupational Therapy, School of Health Sciences
Zip code
324-8501
Address
2600-1, Kitakanemaru, Ohtawara City, Tochigi, Japan
TEL
090-8000-8207
Homepage URL
mm@iuhw.ac.jp
Sponsor or person
Institute
Kirin Holdings Company, Limited
Beverages Laboratories, Research and Development Division
Institute
Department
Personal name
Funding Source
Organization
Kirin Holdings Company, Limited
Beverages Laboratories, Research and Development Division
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office of Ethical Review Committee IUHW Ohtawara Region
Address
2600-1 Kitakanemaru, Ohtawara City, Tochigi, Japan
Tel
0287-24-3000 / +81-287-24-3000
s-rinri@iuhw.ac.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
国際医療福祉大学（栃木県）/ International University of Health and Welfare (Tochigi)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 26 | 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
| 2019 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 09 | Day |
Last modified on
| 2019 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042929
