UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025895
Receipt number R000029773
Scientific Title Effects of 8 days ingestion of LES001(Development code) targeted at females 2
Date of disclosure of the study information 2017/01/30
Last modified on 2017/11/10 08:36:04

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Basic information

Public title

Effects of 8 days ingestion of LES001(Development code) targeted at females 2

Acronym

Effects of 8 days ingestion of LES001(Development code) targeted at females 2

Scientific Title

Effects of 8 days ingestion of LES001(Development code) targeted at females 2

Scientific Title:Acronym

Effects of 8 days ingestion of LES001(Development code) targeted at females 2

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Cardiology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Efficacy trial of long-term ingestion of LES001(Development code) on skin microcirculation in healthy females.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Measurements of skin microcirculatory function and so on, before and after ingestion of LES001(Development code) for 8 days.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of 3 active capsules a day within 30 minutes after breakfast for 8days. After washout about 3 weeks, ingestion of 3 placebo capsules a day within 30 minutes after breakfast for 8days.

Interventions/Control_2

Ingestion of 3 placebo capsules a day within 30 minutes after breakfast for 8days. After washout about 3 weeks, ingestion of 3 active capsules a day within 30 minutes after breakfast for 8days.

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

49 years-old >=

Gender

Female

Key inclusion criteria

-Healthy female
-A person with a stable menstrual cycle

Key exclusion criteria

-Subjects with a food allergy(perilla)
-Subjects with an unstable menstrual cycle
-Subjects who are influenced by adhesion
-Subjects with smoking habit
-Subjects who have been suffered from a critical disease
-Subjects with the illness of a vascular function
-Subjects who are taking prescription medicine
-Subjects deemed inappropriate to participate in this study by the principle investigator

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takatoshi Murase

Organization

Kao Corporation

Division name

R&D -Core Technology- Biological Science Research

Zip code


Address

2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN

TEL

0285-68-7871

Email

murase.takatoshi@kao.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mayumi Ohtsuka

Organization

Kao Corporation

Division name

R&D -Core Technology- Biological Science Research

Zip code


Address

2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN

TEL

0285-68-7458

Homepage URL


Email

ohtsuka.mayumi@kao.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


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

花王株式会社栃木事業場(栃木県)


Other administrative information

Date of disclosure of the study information

2017 Year 01 Month 30 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

2017 Year 01 Month 25 Day

Date of IRB


Anticipated trial start date

2017 Year 02 Month 06 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 01 Month 30 Day

Last modified on

2017 Year 11 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029773


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name