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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025895
Receipt No. 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

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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
Institute Kao Corporation
Institute
Department

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
URL(English) https://upload.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


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