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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040270
Receipt No. 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

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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
Email 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
Email nnaoki@n-fukushi.ac.jp

Sponsor
Institute Nihon Fukushi University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045942

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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