UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036916 |
|---|---|
| Receipt number | 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 | 2019/09/01 16:18:00 |
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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
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
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2019 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 19 | Day |
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 | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042069
