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 2020/03/23 09:16:25

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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

Email

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


Email

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

Email

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


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

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

2020 Year 03 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033361


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name