UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040270 |
|---|---|
| Receipt number | R000045942 |
| Scientific Title | A study on the effect of microbubble bathing on Thermal and washing in human |
| Date of disclosure of the study information | 2020/04/29 |
| Last modified on | 2020/04/29 20:34:07 |
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Basic information
Public title
Thermal and washing effect of microbubble bathing
Acronym
Thermal and washing effect of microbubble bathing
Scientific Title
A study on the effect of microbubble bathing on Thermal and washing in human
Scientific Title:Acronym
Effect of microbubble bathing on Thermal and washing in human
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Thermal and washing effects of microbubble bathing
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comprehensive evaluation
Key secondary outcomes
1. thermal effect: body temperature, skin temperature, skin blood flow, heat flux, hert rate variability
2. washing effect: nonenal,isovaleric acid
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Ultrafine bubble bathing(water temperature:40 degree C, 10 min)
Interventions/Control_2
Microbubble bathing(water temperature:40 degree C, 10 min)
Interventions/Control_3
tap water bathing(water temperature:40 degree C, 10 min)
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
| 30 | years-old | < |
Age-upper limit
| 55 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adult men and women taking a bath on daily life
Key exclusion criteria
cardiovascular and skin diseases
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | nishimura |
Organization
Nihon Fukushi University
Division name
Sport Sciences
Zip code
470-3295
Address
Okuda, Mihama, Chita, Aichi
TEL
0569-87-2211
nnaoki@n-fukushi.ac.jp
Public contact
Name of contact person
| 1st name | naoki |
| Middle name | |
| Last name | nishimura |
Organization
Nihon Fukushi University
Division name
Sport Sciences
Zip code
470-3295
Address
Okuda, Mihama, Chita, Aichi
TEL
0569-87-2211
Homepage URL
nnaoki@n-fukushi.ac.jp
Sponsor or person
Institute
Nihon Fukushi University
Institute
Department
Personal name
Funding Source
Organization
Nihon Fukushi University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon Fukushi University
Address
Okuda, Mihama, Chita, Aichi
Tel
0569-87-2211
nnaoki@n-fukushi.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
12
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
| 2019 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 01 | 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 | 04 | Month | 29 | Day |
Last modified on
| 2020 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045942
