UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037870 |
|---|---|
| Receipt number | 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 | 2021/03/02 12:32:41 |
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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
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
k3niwa@nodai.ac.jp
Sponsor or person
Institute
Tokyo University of Agriculture
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2019 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 01 | Day |
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
| 2021 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043133
