UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026683 |
|---|---|
| Receipt number | 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 10:28:53 |
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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
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
kajiyama.asami@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030641
