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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026683
Receipt No. R000030641
Scientific Title A study for the long-term continuous intake of a plant extracts containing drink.
Date of disclosure of the study information 2017/04/05
Last modified on 2018/09/28

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Basic information
Public title A study for the long-term continuous intake of a plant extracts containing drink.
Acronym A study for the long-term continuous intake of a plant extracts containing drink.
Scientific Title A study for the long-term continuous intake of a plant extracts containing drink.
Scientific Title:Acronym A study for the long-term continuous intake of a plant extracts containing drink.
Region
Japan

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

Objectives
Narrative objectives1 The objective of this study is to evaluate the effects of long-term continuous intake of the plant extract containing drink on condition of skin and whole body.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measurement of skin condition
Key secondary outcomes Measurement of vascular function

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food Maneuver
Interventions/Control_1 One vegetable extract combination drink per day is made to take in for one year to an article-specified A user.
Interventions/Control_2 One vegetable extract combination drink per day is made to take in for one year to an article-specified B user.
Interventions/Control_3 One vegetable extract combination drink per day is made to take in for one year to an article-specified intact person.
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
40 years-old <=
Age-upper limit
59 years-old >=
Gender Female
Key inclusion criteria Article-specified user
-Persons who have dry skin.
-Persons who sense the cold in winter.
-Persons who have felt mental stress.
-Persons to whom it seems that the face is tired.

Article-specified intact person
-Persons who have a trouble beige.
-Persons to whom flesh color is somber.
-Persons who care about appearance age next to the skin being high.
Key exclusion criteria -Patients with atopic dermatitis.
-Persons of skin to whom skin troubles by cosmetics happens easily.
-Persons who have severe allergic disease as pollen allergy, rhinitis, atopicdermatitis.
-Patients with vascular function disorder.
-Persons who have severe poor circulation.
-Persons who have problems with electrocardiogram test such as arrhythmia.
-Persons who take medicine.
-Persons who went to hospital regularly to the medical institution within the past one month.
-Persons who have received a cosmetic medicine (cosmetic surgery, injection of collagen, laser treatment, etc.)
-Current smoker .
-Persons who are pregnant or lactating, or plan to become pregnant in the near future.
-Persons who do esthetic program and peeling periodically or planned to do them in exam period.
-Persons who ate beauty food within the past one month.
-Persons to whom the person himself/herself or a family is engaged in an advertising agency, investigation and consultant business, mass media, and food, cosmetics and the health article manufacturing industry.
-Persons who plan to become participates in the other clinical studies or exam.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akane Suma
Organization Kao Corporation
Division name R&D-Skin Care Products Research
Zip code
Address 2-1-3, Bunka, Sumida-ku Tokyo 131-8501, JAPAN
TEL 03-5630-9581
Email suma.akane@kao.com

Public contact
Name of contact person
1st name
Middle name
Last name Asami Kajiyama
Organization Kao Corporation
Division name R&D-Skin Care Products Research
Zip code
Address 2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL 03-5630-9581
Homepage URL
Email kajiyama.asami@kao.com

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization Kao 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
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 花王株式会社ソフトリサーチセンター(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 05 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
2017 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 06 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 03 Month 24 Day
Last modified on
2018 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030641

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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