UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041975 |
|---|---|
| Receipt number | R000047911 |
| Scientific Title | Examination of foods ingestion containing plant extract 1 |
| Date of disclosure of the study information | 2020/10/02 |
| Last modified on | 2020/10/02 08:40:53 |
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Basic information
Public title
Examination of foods ingestion containing plant extract 1
Acronym
Examination of foods ingestion containing plant extract 1
Scientific Title
Examination of foods ingestion containing plant extract 1
Scientific Title:Acronym
Examination of foods ingestion containing plant extract 1
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of plant extract on skin and health condition.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood component
Key secondary outcomes
subjective evaluation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of placebo food for 4 weeks
Interventions/Control_2
Ingestion of active food for 4 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
| 25 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Healthy female aged from 25 to 39 years old
2. Subjects who have dry skin.
3. Subjects who are aware of the inelasticity of the skin
4. Subjects who are aware of skin dullness
5. Subjects who are aware of wrinkles on her skin
6. Menstrual cycle is stable
7. Subjects who can forbid intaking supplements.
Key exclusion criteria
1. Subjects who have been suffered from bronchial asthma, allergic rhinitis, conjunctivitis, and atopic dermatitis
2. Subjects who have the rash resulting from psoriasis or skin allergy
3. Subjects who are outpatients or were treated by doctor recently.
4. Subjects who are using external preparations and/or moisturizer for face and arm
5. Subjects who take medicine
6. Subjects who have received or prohibit a cosmetic medicine (cosmetic surgery, injection of collagen, etc.) in face and arm
7. Subjects who have possibilities for emerging allergy to foods and drugs.
8. Subjects who are pregnant or lactating, or planned to become pregnant in the near future.
9. Current smoker
10. Subjects who are participate in the other clinical studies
11. Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akane |
| Middle name | |
| Last name | Suma |
Organization
Kao Corporation
Division name
Skin Care Products Research
Zip code
131-8501
Address
2-1-3 Bunka, Sumida-ku, Tokyo, 131-8501, Japan
TEL
81-(0)3-5630-9581
suma.akane@kao.com
Public contact
Name of contact person
| 1st name | Masako |
| Middle name | |
| Last name | Mizuuchi |
Organization
C&C Corporation
Division name
C&C Corporation
Zip code
104-0045
Address
4-7-5, Tukiji, Chuo-ku, Tokyo, 104-0045, JAPAN
TEL
81-(0)3-3545-3781
Homepage URL
m.mizuuchi@candc.co.jp
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
Human Reserch Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-7263
morisaki.naoko@kao.com
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
築地クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2020 | Year | 12 | 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
| 2020 | Year | 10 | Month | 02 | Day |
Last modified on
| 2020 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047911
