UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029182 |
|---|---|
| Receipt number | R000033361 |
| Scientific Title | Physiological, hematological and dermatological effects of fine bubble bathing. |
| Date of disclosure of the study information | 2019/09/07 |
| Last modified on | 2024/09/30 10:36:13 |
* 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
Physiological, hematological and dermatological effects of fine bubble bathing.
Acronym
Physiological effects of fine bubble bathing.
Scientific Title
Physiological, hematological and dermatological effects of fine bubble bathing.
Scientific Title:Acronym
Physiological effects of fine bubble bathing.
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is to examine physiological, hematological and dermatological effects of fine bubble bathing in healthy adult men.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hyperthermic effect of 10 minutes fine bubble bathing, measured by body temperature changes 15 minutes after bathing.
Key secondary outcomes
Parameters other than body temperatures
1) Physiological changes 15 min after bathing: blood flow velocity, blood pressure and sweat rate.
2) Hematological changes 10 min after bathing: venous blood pH, PO2, PCO2, glucose, pyruvate, lactate, IGF-1 and insulin levels.
3) Dermatological changes 15 min after bathing: skin pH, moisture levels, sebum quantity, and residual contaminants and bacterias
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
bathing for 10 min without fine bubble
Interventions/Control_2
bathing with fine bubble generated by new method
Interventions/Control_3
bathing with fine bubbles generated by pressurized dissolution method
Interventions/Control_4
bathing without fine bubble which was generated from 10 min to 5 min before bathing by new method
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
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy male adults who can comply study protocol, and who submitted written consent.
Key exclusion criteria
1. Those who have at least 1 contraindication for hot spring bathing according to No. 1407012, issued on July 1st, 2014, by Nature Conservation Bureau, Ministry of the Environment.
2. Those who have skin diseases.
3. Those who have hyperhidrosis.
4. Those who are considered to be unsuitable, decided by a doctor responsible of this study.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Koibuchi |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Integrative Physiology
Zip code
371-8511
Address
3-39-22 Showa-machi, Maebashi
TEL
027-220-7923
nkoibuch@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriyuki |
| Middle name | |
| Last name | Koibuchi |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Integrative Physiology
Zip code
371-8511
Address
3-39-22 Showa-machi, Maebashi
TEL
027-220-7923
Homepage URL
nkoibuch@gunma-u.ac.jp
Sponsor or person
Institute
Kiboshi, Inc.
Institute
Department
Personal name
Funding Source
Organization
Kiboshi, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kiboshi, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Hospital Clinical Research Review Board
Address
3-39-15 Showa-machi, Maebashi
Tel
027-220-8740
gunmaciru-office@umin.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
群馬大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 07 | 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
| Delay expected |
Results Delay Reason
Delay in manuscript preparation
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
| 2017 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 18 | Day |
Last modified on
| 2024 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033361
