UMIN-CTR Clinical Trial

Public title

A study for the long-term continuous intake of a plant extracts containing drink.

Acronym

A study for the long-term continuous intake of a plant extracts containing drink.

Scientific Title

A study for the long-term continuous intake of a plant extracts containing drink.

Scientific Title:Acronym

A study for the long-term continuous intake of a plant extracts containing drink.

Region

Japan

Condition

Healthy adults

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 long-term continuous 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

Key secondary outcomes

Measurement of vascular function

Study type

Interventional

Basic design

Factorial

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Food

Maneuver

Interventions/Control_1

One vegetable extract combination drink per day is made to take in for one year to an article-specified A user.

Interventions/Control_2

One vegetable extract combination drink per day is made to take in for one year to an article-specified B user.

Interventions/Control_3

One vegetable extract combination drink per day is made to take in for one year to an article-specified intact person.

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

40

years-old

<=

Age-upper limit

59

years-old

>=

Gender

Female

Key inclusion criteria

Article-specified user
-Persons who have dry skin.
-Persons who sense the cold in winter.
-Persons who have felt mental stress.
-Persons to whom it seems that the face is tired.

Article-specified intact person
-Persons who have a trouble beige.
-Persons to whom flesh color is somber.
-Persons who care about appearance age next to the skin being high.

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.
-Patients with vascular function disorder.
-Persons who have severe poor circulation.
-Persons who have problems with electrocardiogram test such as arrhythmia.
-Persons who take medicine.
-Persons who went to hospital regularly to the medical institution within the past one month.
-Persons who have received a cosmetic medicine (cosmetic surgery, injection of collagen, laser treatment, etc.)
-Current smoker .
-Persons who are pregnant or lactating, or plan to become pregnant in the near future.
-Persons who do esthetic program and peeling periodically or planned to do them in exam period.
-Persons who ate beauty food within the past one month.
-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

30

Name of lead principal investigator

1st name
Middle name
Last name	Akane Suma

Organization

Kao Corporation

Division name

R&D-Skin Care Products Research

Zip code

Address

2-1-3, Bunka, Sumida-ku Tokyo 131-8501, JAPAN

TEL

03-5630-9581

Email

suma.akane@kao.com

Name of contact person

1st name
Middle name
Last name	Asami Kajiyama

Organization

Kao Corporation

Division name

R&D-Skin Care Products Research

Zip code

Address

2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN

TEL

03-5630-9581

Homepage URL

Email

kajiyama.asami@kao.com

Institute

Kao Corporation

Institute

Department

Personal name

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

花王株式会社ソフトリサーチセンター（東京都）

Date of disclosure of the study information

2017

Year

04

Month

05

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

2017

Year

03

Month

15

Day

Date of IRB

Anticipated trial start date

2017

Year

04

Month

06

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

03

Month

24

Day

Last modified on

2018

Year

09

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030641