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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028045
Receipt No. R000032084
Scientific Title Effects of cosmetic treatment on somatopsychology.
Date of disclosure of the study information 2017/07/04
Last modified on 2018/02/20

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Basic information
Public title Effects of cosmetic treatment on somatopsychology.
Acronym Effects of cosmetic treatment on somatopsychology.
Scientific Title Effects of cosmetic treatment on somatopsychology.
Scientific Title:Acronym Effects of cosmetic treatment on somatopsychology.
Region
Japan

Condition
Condition Healthy person
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigate effects of cosmetic treatment on somatopsychology.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in skin quality
Key secondary outcomes 1.Near Infrared Spectroscopy
2.Heart rate variability
3.Profile of Mood States
4.State Trait Anxiety Inventory
5.Chinese medicine questionnaire

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Cosmetic treatment
Interventions/Control_2 no treatment
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

Not applicable
Gender Male and Female
Key inclusion criteria Healthy person
Key exclusion criteria Subjects who have history of cerebrovascular or psychiatric disorder.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ko Nishimura
Organization Suzuka University of Medical Science
Division name Institute of Traditional Chinese Medicine
Zip code
Address 1275-3, Kishioka,Suzuka-city, Mie, JAPAN
TEL 059-381-2385
Email ko-n@suzuka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ken Takagi
Organization Suzuka University of Medical Science
Division name Institute of Traditional Chinese Medicine
Zip code
Address 1275-3, Kishioka,Suzuka-city, Mie, JAPAN
TEL 059-381-2385
Homepage URL
Email takagi17@suzuka-u.ac.jp

Sponsor
Institute Suzuka University of Medical Science
Institute
Department

Funding Source
Organization Suzuka University of Medical Science
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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
2017 Year 07 Month 04 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 02 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 03 Day
Last modified on
2018 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032084

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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