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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036916
Receipt No. R000042069
Scientific Title The test of effect on stress reduction by using higher humidity and lower temperature sauna.
Date of disclosure of the study information 2019/06/03
Last modified on 2019/05/31

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Basic information
Public title The test of effect on stress reduction
Acronym The test of effect on stress reduction
Scientific Title The test of effect on stress reduction by using higher humidity and lower temperature sauna.
Scientific Title:Acronym The test of effect on stress reduction by using higher humidity and lower temperature sauna.
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To prove benefits of a higher humidity and lower temperature sauna on stress reduction.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Salivary cortisol, salivary IgA, salivary oxytocin
Key secondary outcomes Salivary amylase, Salivary chromogranin, Skin moisture level, Blood pressure, Body temperature, Body weight, The incidence of side effects and/or adverse events

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Using a higher humidity and lower temperature sauna at first visit. After rest period, using a higher temperature sauna at second visit.
Interventions/Control_2 Using a higher temperature sauna at first visit. After rest period, using a higher humidity and lower temperature sauna at second visit.
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
60 years-old >
Gender Male
Key inclusion criteria 1)Males aged 40 to 59 at registration.
2) Subjects who has systolic blood pressure less than 159 mmHg or diastolic blood pressure less than 99 mmHg in blood pressure measurement at pre-test
3) Subjects who are usually aware of a certain level of stress
4) Subjects giving written informed consent.
Key exclusion criteria 1) Subjects who have been diagnosed with a mental disorder such as depression in the past, or are currently undergoing treatment.
2) Subjects who are continuing treatment with medicine.
3) Subjects who feels extremely frustrated and has trouble with everyday life.
4) Subjects who is aware that it is easy to dry in the mouth or little salivation.
5) Subjects who are claustrophobic and can not enter the sauna room.
6) Subjects who difficult to sweat in sauna bath.
7) Subjects who have tattoo.
8) Subjects who have wide barns scar.
9) Subjects with bruises, scratches, or acne on their cheeks.
10) Subjects who is severely sunburned or who works or plays sports outdoors for a long time.
11) Subjects who have special care on the face skin or arm skin (facial esthetics, body esthetics, facial care, peeling, laser treatment, hair removal etc.).
12) Subjects who plan to travel abroad or s wimming bath in the test period
13) Subjects who constantly use medicines, supplements having a possibility of affecting test results.
14) Subjects who have a history of and/or a history of serious illness in the heart, liver, kidney, digestive tract etc.
15) Subjects who excessive alcohol intake.
16) Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work.
17) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests.
18) Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Seiji
Middle name
Last name Shioda
Organization SHIODA Life Science Inc.
Division name President
Zip code 106-0031
Address Sunrise Roppongi 3B, 3-2-9 Nishiazabu, Minato-ku, Tokyo, Japan
TEL 03-6804-5371
Email shioda@hoshi.ac.jp

Public contact
Name of contact person
1st name Makoto
Middle name
Last name Ichinohe
Organization CPCC Company Limited
Division name Planning & Sales Department
Zip code 101-0047
Address 4F Sanwauchikannda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL 03-5927-3112
Homepage URL
Email cpcc-contact@cpcc.co.jp

Sponsor
Institute CPCC Company Limited
Institute
Department

Funding Source
Organization SHIODA Life Science Inc.
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 Institutional Review Board of Chiyoda Paramedical Care Clinic
Address 2F Sanwauchikannda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
Tel 3-5297-5548
Email IRB@cpcc.co.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
2019 Year 06 Month 03 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 04 Month 20 Day
Date of IRB
Anticipated trial start date
2019 Year 06 Month 04 Day
Last follow-up date
2019 Year 07 Month 31 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 05 Month 31 Day
Last modified on
2019 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042069

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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