UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for the effect of intake of a plant extracts containing drink on skin conditions and vascular functions.
Title of the study (Brief title)	A study for the effect of intake of a plant extracts containing drink on skin conditions and vascular functions.
Region	Japan

Condition
Condition	Dry skin
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 intake of the plant extract containing drink on skin conditions and vascular function
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Measurement of vascular function, (measurement time : 0, 30, 60, 90, 120 mins after ingestion of the test drink)
Key secondary outcomes	Measurement of skin condition, Observation of skin texture, (measurement time : 0, 30, 60, 90, 120 mins after ingestion of the test drink)

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	No need to know

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of a bottle of placebo drink at the evaluation day. After 7 days, ingestion of two bottles of test drink at the evaluation day. Furthermore, 7 days later, ingestion of a bottle of test drink at the evaluation day.
Interventions/Control_2	Ingestion of two bottles of test drink at the evaluation day. After 7 days, ingestion of a bottle of test drink at the evaluation day. Furthermore, 7 days later, ingestion of a bottle of placebo drink at the evaluation day.
Interventions/Control_3	Ingestion of a bottle of test drink at the evaluation day. After 7 days, ingestion of a bottle of placebo drink at the evaluation day. Furthermore, 7 days later, ingestion of two bottles of test drink at the evaluation day.
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	35 years-old >=
Gender	Female
Key inclusion criteria	1. Healthy female aged from 25 to 35 years old 2. Persons who have felt mental stress for recent 1 or 2 months. 3. Persons who have skin troubles. 4. Menstrual cycle is stable at 25 to 30 days. 5. BMI is from 18.5 to 25.0
Key exclusion criteria	1. Persons who are outpatients or were treated by doctor recently. 2. Persons who are pregnant or lactating, or planned to become pregnant in the near future. 3. Persons who have problems with electrocardiogram test such as arrhythmia. 4. Persons who take medicine (example: sleeping pills, anti-allergic drugs, hormone drugs, laxative, antiflatulent, and other medicines) 5. Persons who routinely take quasi-drugs and healthy foods. 6. Persons who have severe allergic disease as pollen allergy, rhinitis, atopic dermatitis. 7. Persons who have possibilities for emerging allergy to foods and cosmetics. 8. Current smoker 9. Persons who have received a cosmetic medicine (cosmetic surgery, injection of collagen, laser treatment, etc.) 10. Patients with atopic dermatitis. 11. Persons who are participate in the other clinical studies 12. Patients with vascular function disorder. 13. Persons who have severe poor circulation. 14. Persons who are judged as unsuitable for the study by the investigator for other reason.
Target sample size	18

Research contact person
Name of lead principal investigator	Yoshinori Sugiyama
Organization	Kao Corporation
Division name	Health Beauty Products Research
Address	2-1-3, Bunka, Sumida-ku, Tokyo
TEL	03-5630-9441
Email	sugiyama.yoshinori@kao.co.jp

Public contact
Name of contact person	Sachie Ueda
Organization	Kao Corporation
Division name	Health Beauty Products Research
Address	2-1-3, Bunka, Sumida-ku, Tokyo
TEL	03-5630-9441
Homepage URL
Email	ueda.sachie@kao.co.jp

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)	None

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　ヘルスビューティー研究所 (Kao Corporation, Health Beauty Products Research)

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 16 Day
Anticipated trial start date	2015 Year 11 Month 02 Day
Last follow-up date	2015 Year 12 Month 21 Day
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	2015 Year 10 Month 22 Day
Last modified on	2016 Year 10 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022495