UMIN-CTR Clinical Trial

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

Condition
Condition	Healthy people
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 repeated 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 (measurement time: 0, 2, 4, 8weeks after ingestion of the test drink)
Key secondary outcomes	Observation of skin texture Measurement of vascular function (measurement time: 0, 2, 4, 8weeks after ingestion of the test drink)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
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 a bottle of placebo drink once a day for 8 weeks.
Interventions/Control_2	Ingestion of a bottle of test drink once a day for 8 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	35 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Healthy male and female aged from 25 to 35 years old 2. Persons who have felt mental stress, poor-quality sleep or fatigue for recent 1 or 2 months. 3. Persons who are worried about excessive sebum associated to one's health. 4. Persons who are worried about one's body odor. 5. Menstrual cycle is stable at 26 to 30 days. 6. 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	40

Research contact person
Name of lead principal investigator	Sumio Kondo
Organization	Medical Corporation Kensho-kai, Fukushima Healthcare Center
Division name	Department of Internal Medicine, Neurosurgery
Address	2-12-16, Tamagawa, Fukushima-ku, Osaka
TEL	06-6441-6848
Email	ko283434@ares.eonet.ne.jp

Public contact
Name of contact person	Masafumi Takano
Organization	DRC Co., Ltd
Division name	Product Testing Department
Address	Tabuchi Bldg. No.9 5F , 2-10-31, Higashi-Temma, Kita-ku, Osaka
TEL	06-6882-1130
Homepage URL
Email	m.takano@drc-web.co.jp

Sponsor
Institute	DRC Co., Ltd.
Institute
Department

Funding Source
Organization	Kao Corporation
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	None
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

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 29 Day
Anticipated trial start date	2016 Year 02 Month 12 Day
Last follow-up date	2016 Year 05 Month 08 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	2016 Year 02 Month 10 Day
Last modified on	2017 Year 02 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024169