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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020973
Receipt No. R000024169
Scientific Title A study for the effect of the intake of a plant extracts containing drink on condition of skin and whole body.
Date of disclosure of the study information 2016/02/11
Last modified on 2017/02/09

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Basic information
Public title A study for the effect of the intake of a plant extracts containing drink on condition of skin and whole body.
Acronym A study for the effect of the intake of a plant extracts containing drink on condition of skin and whole body.
Scientific Title A study for the effect of the intake of a plant extracts containing drink on condition of skin and whole body.
Scientific Title:Acronym 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
1st name
Middle name
Last name Sumio Kondo
Organization Medical Corporation Kensho-kai, Fukushima Healthcare Center
Division name Department of Internal Medicine, Neurosurgery
Zip code
Address 2-12-16, Tamagawa, Fukushima-ku, Osaka
TEL 06-6441-6848
Email ko283434@ares.eonet.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masafumi Takano
Organization DRC Co., Ltd
Division name Product Testing Department
Zip code
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

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 01 Month 29 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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