UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042069