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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002667
Receipt No. R000003119
Scientific Title The Chiba Health Effects Study On Ceramic Bathing
Date of disclosure of the study information 2009/10/25
Last modified on 2011/08/08

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Basic information
Public title The Chiba Health Effects Study On Ceramic Bathing
Acronym CHESOC
Scientific Title The Chiba Health Effects Study On Ceramic Bathing
Scientific Title:Acronym CHESOC
Region
Japan

Condition
Condition mental illness
ophthalmic disorder
ENT disorder
heart disease (incl. hypertension)
digestive disorder
orthopedic disorder
dermatological disorder
neurological disorder
genitourinary disorder
infectious disease
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Cardiology Pneumology Endocrinology and Metabolism
Nephrology Neurology Clinical immunology
Psychosomatic Internal Medicine Infectious disease Geriatrics
Obsterics and gynecology Ophthalmology Dermatology
Psychiatry Oto-rhino-laryngology Orthopedics
Urology Anesthesiology Rehabilitation medicine
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Revealing the effectiveness of Ceramic Bathing against physical and mental probrems
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes physiological index (blood pressure, pulse rate)
body weight
SF-8
Profile of Mood States - Brief Form
Cornell Medical Index
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Taking a bath in Ceramic Bathing for 8 weeks (2 times per week)
Interventions/Control_2
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Men and women aged 18 and over
Key exclusion criteria Those who have diagnosed with the condition that they should not take Ceramic Bathing
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noda Tatsuya
Organization Hamamatsu University School of Medicine
Division name Department of Community Health and Preventive Medicine
Zip code
Address Handayama 1-20-1, Higashi-ku, Shizuoka, JAPAN
TEL 053-435-2333
Email

Public contact
Name of contact person
1st name
Middle name
Last name Noda Tatsuya
Organization Hamamatsu University School of Medicine
Division name Department of Community Health and Preventive Medicine
Zip code
Address Handayama 1-20-1, Higashi-ku, Shizuoka, JAPAN
TEL
Homepage URL
Email nodat@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Fine Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2009 Year 10 Month 25 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
2009 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2010 Year 05 Month 01 Day
Date of closure to data entry
2010 Year 08 Month 01 Day
Date trial data considered complete
2010 Year 10 Month 01 Day
Date analysis concluded
2011 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 10 Month 25 Day
Last modified on
2011 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003119

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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