UMIN-CTR Clinical Trial

Public title

A study for the effect of intake of a plant extracts containing drink on skin conditions and vascular functions.

Acronym

A study for the effect of intake of a plant extracts containing drink on skin conditions and vascular functions.

Scientific Title

A study for the effect of intake of a plant extracts containing drink on skin conditions and vascular functions.

Scientific Title:Acronym

A study for the effect of intake of a plant extracts containing drink on skin conditions and vascular functions.

Region

Japan

Condition

Dry skin

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 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

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)

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Yoshinori Sugiyama

Organization

Kao Corporation

Division name

Health Beauty Products Research

Zip code

Address

2-1-3, Bunka, Sumida-ku, Tokyo

TEL

03-5630-9441

Email

sugiyama.yoshinori@kao.co.jp

Name of contact person

1st name
Middle name
Last name	Sachie Ueda

Organization

Kao Corporation

Division name

Health Beauty Products Research

Zip code

Address

2-1-3, Bunka, Sumida-ku, Tokyo

TEL

03-5630-9441

Homepage URL

Email

ueda.sachie@kao.co.jp

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)

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

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

Date of disclosure of the study information

2015

Year

11

Month

02

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

2015

Year

10

Month

16

Day

Date of IRB

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

Other related information

Registered date

2015

Year

10

Month

22

Day

Last modified on

2016

Year

10

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022495