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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037870
Receipt No. R000043133
Scientific Title Study on effects of placenta intake on skin characteristics
Date of disclosure of the study information 2019/11/01
Last modified on 2019/08/31

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Basic information
Public title Effects of placenta intake on skin conditions
Acronym Effects of placenta on skin
Scientific Title Study on effects of placenta intake on skin characteristics
Scientific Title:Acronym Effects of placenta on skin characteristics
Region
Japan

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

Objectives
Narrative objectives1 To clarify the effects of placenta intake on the skin characteristics such as degree of multiple layered cells and water or oil content.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Degree of multiple layered keratinocytes, water content. oil content, and water transpiration quantity of skin.
(Before the intake, and 2, 4, and 6 weeks after the onset of placenta intake)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Food
Interventions/Control_1 Subjects intake 8 tablets of commercial placenta supplements (equivalent to porcine placenta extract 200 mg) daily for 6 weeks.
Interventions/Control_2 Subjects intake 8 tablets of placebo daily for 6 weeks.
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
30 years-old >
Gender Male and Female
Key inclusion criteria Healthy men and women with no skin diseases such as atopic dermatitis
Key exclusion criteria Persons with skin diseases such as atopic dermatitis
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Koichi
Middle name
Last name Niwa
Organization Tokyo University of Agriculture
Division name Department of Food, Aroma and Cosmetics, Faculty of Bioindustry
Zip code 099-2493
Address 196 Yasaka, Abashiri, Hokkaido
TEL 0152-48-3841
Email k3niwa@nodai.ac.jp

Public contact
Name of contact person
1st name Koichi
Middle name
Last name Niwa
Organization Tokyo University of Agriculture
Division name Department of Food, Aroma and Cosmetics, Faculty of Bioindustry
Zip code 099-2493
Address 196 Yasaka, Abashiri, Hokkaido
TEL 0152-48-3841
Homepage URL
Email k3niwa@nodai.ac.jp

Sponsor
Institute Tokyo University of Agriculture
Institute
Department

Funding Source
Organization DHC Corporation
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 Research Institute, Tokyo University of Agriculture
Address 1-1-1, Sakuraoka, Setagaya, Tokyo
Tel 03-5477-2532
Email nri@nodai.ac.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 11 Month 01 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 10 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 11 Month 01 Day
Last follow-up date
2021 Year 03 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 08 Month 31 Day
Last modified on
2019 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043133

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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