UMIN-CTR Clinical Trial

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

Healthy people

Classification by specialty

Dermatology

Adult

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

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

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

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

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

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

Institute

DRC Co., Ltd.

Institute

Department

Personal name

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

None

Name of secondary funder(s)

None

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

02

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

02

Month

10

Day

Last modified on

2017

Year

02

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024169