UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041886
Receipt number R000047811
Scientific Title Examination of foods ingestion containing plant extract.
Date of disclosure of the study information 2020/09/28
Last modified on 2020/09/24 17:12:25

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Basic information

Public title

Examination of foods ingestion containing plant extract.

Acronym

Examination of foods ingestion containing plant extract.

Scientific Title

Examination of foods ingestion containing plant extract.

Scientific Title:Acronym

Examination of foods ingestion containing plant extract.

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Dermatology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effects of plant extract on skin and health condition.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

skin condition

Key secondary outcomes

blood component
subjective evaluation


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

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 placebo food for 4 weeks

Interventions/Control_2

Ingestion of active food for 4 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

20 years-old <=

Age-upper limit

65 years-old >=

Gender

Female

Key inclusion criteria

1. Healthy female aged from 20 to 65 years old
2.Subjects who can forbid intaking supplements

Key exclusion criteria

1. Subjects who have received or prohibit a cosmetic medicine (cosmetic surgery, injection of collagen, etc.) in face and arm
2. Subjects who have possibilities for emerging allergy to foods and drugs.
3. Subjects who are pregnant or lactating, or planned to become pregnant in the near future.
4. Current smoker
5. Subjects who are participate in the other clinical studies
6. Subjects who are judged as unsuitable for the study by the investigator for other reason.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Akane
Middle name
Last name Suma

Organization

Kao Corporation

Division name

Skin Care Products Research

Zip code

131-8501

Address

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

TEL

81-(0)3-5630-9581

Email

suma.akane@kao.com


Public contact

Name of contact person

1st name Masako
Middle name
Last name Mizuuchi

Organization

C&C Corporation

Division name

C&C Corporation

Zip code

104-0045

Address

4-7-5, Tukiji, Chuo-ku, Tokyo, 104-0045, JAPAN

TEL

81-(0)3-3545-3781

Homepage URL


Email

m.mizuuchi@candc.co.jp


Sponsor or person

Institute

Kao Corporation

Institute

Department

Personal name



Funding Source

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Human Research Ethics Committee, Kao Corporation

Address

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

Tel

+81-3-5630-7263

Email

morisaki.naoko@kao.com


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

花王株式会社(東京都)


Other administrative information

Date of disclosure of the study information

2020 Year 09 Month 28 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

Preinitiation

Date of protocol fixation

2020 Year 09 Month 28 Day

Date of IRB

2020 Year 09 Month 28 Day

Anticipated trial start date

2020 Year 09 Month 30 Day

Last follow-up date

2020 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 09 Month 24 Day

Last modified on

2020 Year 09 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047811


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name