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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024110
Receipt No. R000027755
Scientific Title Study of the effects of plant extract on skin surface temperature and blood flow
Date of disclosure of the study information 2016/12/15
Last modified on 2017/09/21

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Basic information
Public title Study of the effects of plant extract on skin surface temperature and blood flow
Acronym Study of the effects of plant extract on skin surface temperature and blood flow
Scientific Title Study of the effects of plant extract on skin surface temperature and blood flow
Scientific Title:Acronym Study of the effects of plant extract on skin surface temperature and blood flow
Region
Japan

Condition
Condition No
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of plant extract on skin surface temperature and blood flow.
To investigation of interaction of plant extract with a food ingredient.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes skin surface temperature (First observation, Second observation, Third observation)
blood flow (First observation, Second observation, Third observation)
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 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Capsules containing plant extract, single daily ingestion.
Interventions/Control_2 Capsules containing plant extract and a food ingredient, single daily ingestion.
Interventions/Control_3 Placebo capsules not containing plant extract and a food ingredient, single daily ingestion.
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
60 years-old >=
Gender Male and Female
Key inclusion criteria (1) Individuals aged from 20 to 60 years, when giving the informed consent.
(2) Individuals who give the informed consents in writing, after receiving enough explanation of the purpose and details of the study, understanding the study well, and deciding to attend the study with their own will.
Key exclusion criteria (1) Individuals who are under treatment of some disease.
(2) Individuals who have possibility of allergy symptoms onset.
(3) Individuals who are under treatment of skin disease (e.g., atopic dermatitis).
(4) Individuals who are, or are under treatment, or have a history of serious disease (e.g., liver disease, kidney disease, heart disease) or/and thyroid gland disease, adrenal gland disease, and/or metabolic disorder.
(5) Individuals who are pregnant or lactating.
(6) Individuals who are planned to participate in other clinical study during this study periods.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mika Miyake
Organization Kirin Company, Limited
Division name Research laboratories for health science & food technologies
Zip code
Address 1-13-5,Fukuura,Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL 045-330-9837
Email m-miyake@kirin.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mika Miyake
Organization Kirin Company, Limited
Division name Research laboratories for health science & food technologies
Zip code
Address 1-13-5,Fukuura,Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL 045-330-9837
Homepage URL
Email m-miyake@kirin.co.jp

Sponsor
Institute Kirin Company, Limited
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 15 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
2016 Year 09 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 26 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
2016 Year 09 Month 20 Day
Last modified on
2017 Year 09 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027755

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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