UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024110 |
|---|---|
| Receipt number | 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 09:12:21 |
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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
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
m-miyake@kirin.co.jp
Sponsor or person
Institute
Kirin Company, Limited
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
