UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023061 |
|---|---|
| Receipt number | R000026581 |
| Scientific Title | Continued ingestion test of the plant extract containing drink |
| Date of disclosure of the study information | 2016/07/08 |
| Last modified on | 2016/07/25 20:35:32 |
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Basic information
Public title
Continued ingestion test of the plant extract containing drink
Acronym
Continued ingestion test of the plant extract containing drink
Scientific Title
Continued ingestion test of the plant extract containing drink
Scientific Title:Acronym
Continued ingestion test of the plant extract containing drink
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the dermatological efficacy of ingesting the plant extract containing drink of healthy female
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of skin condition
(Measurement time: 0, 1 and 2 weeks after ingestion of the test drink.)
Key secondary outcomes
-Observation of skin
-Measurement of vascular function
(Measurement time: 0,1, and 2 weeks after ingestion of the test drink.)
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
| Other |
Interventions/Control_1
Ingestion of active drink once a day for 14days.
Interventions/Control_2
Ingestion of placebo drink once a day
for 14days.
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
| 30 | years-old | <= |
Age-upper limit
| 44 | years-old | >= |
Gender
Female
Key inclusion criteria
-Persons who are healthy and have full time work.
-Persons who sense the stress .
-Persons who think own skin type is dry skin or combination skin.
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.
-Persons who have problems with electrocardiogram test such as arrhythmia.
-The person who went to hospital regularly to the medical institution within the past one month.
-Current smoker
-Persons who are pregnant or lactating, or plan to become pregnant in the near future.
-Persons who may do suntan remarkably exceeding everyday life.
-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
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Kataoka |
Organization
Kao Corporation
Division name
R&D -Development Research- Health Beauty Products Research
Zip code
Address
2-1-3, bunka, sumida-ku, Tokyo, 131-8501, JAPAN
TEL
03-5630-9581
kataoka.kiyoshi@kao.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukinori Nakashima |
Organization
Kao Corporation
Division name
R&D -Development Research- Health Beauty Products Research
Zip code
Address
2-1-3, bunka, sumida-ku, Tokyo, 131-8501, JAPAN
TEL
03-5630-9581
Homepage URL
nakashima.yukinori@kao.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
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 08 | 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
| 2016 | Year | 06 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 09 | 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
| 2016 | Year | 07 | Month | 07 | Day |
Last modified on
| 2016 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026581
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
