UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Continued ingestion test of the plant extract containing drink
Title of the study (Brief title)	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.)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Kiyoshi Kataoka
Organization	Kao Corporation
Division name	R&D -Development Research- Health Beauty Products Research
Address	2-1-3, bunka, sumida-ku, Tokyo, 131-8501, JAPAN
TEL	03-5630-9581
Email	kataoka.kiyoshi@kao.co.jp

Public contact
Name of contact person	Yukinori Nakashima
Organization	Kao Corporation
Division name	R&D -Development Research- Health Beauty Products Research
Address	2-1-3, bunka, sumida-ku, Tokyo, 131-8501, JAPAN
TEL	03-5630-9581
Homepage URL
Email	nakashima.yukinori@kao.co.jp

Sponsor
Institute	Kao corporation
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026581