UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027779 |
|---|---|
| Receipt number | R000031822 |
| Scientific Title | Effect on vascular endothelial function by Perilla oil |
| Date of disclosure of the study information | 2017/06/16 |
| Last modified on | 2019/12/17 10:52:34 |
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Basic information
Public title
Effect on vascular endothelial function by Perilla oil
Acronym
Effect on vascular endothelial function by Perilla oil
Scientific Title
Effect on vascular endothelial function by Perilla oil
Scientific Title:Acronym
Effect on vascular endothelial function by Perilla oil
Region
| Japan |
Condition
Condition
High blood pressure
Hyperlipidemia
Diabetes
Healthy volunteer
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect on vascular endothelial function by Perilla oil
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reactive hyperemia index
Key secondary outcomes
Blood pressure,Blood biochemical examination,
Food records, Medical examination
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Intake of Perilla oil 1cup of tablespoon / day for 1week
Interventions/Control_2
Intake of Olive oil 1cup of tablespoon / day for 1week
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.The person who has two or more risk factor of arteriosclerosis, and are untreated on arteriosclerosis.
2.Participants who receive adequate explanation for participation in this research and provide written informed consent by their own free will.
Key exclusion criteria
1.The person who are taking Perilla oil on daily basis
2.The person who are untreated on arteriosclerosis.
3.Judgement as being ineligible by the investigator or the physician.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinaga Takuma |
Organization
Nanpuh hospital
Division name
Deparment of Clinical Application
Zip code
Address
14-3 Nagata Kagoshima-city Kagoshima
TEL
099-226-9111
t-yoshinaga@nanpuh.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinaga Takuma |
Organization
Nanpuh hospital
Division name
Deparment of Clinical Application
Zip code
Address
14-3 Nagata Kagoshima-city Kagoshima
TEL
099-226-9111
Homepage URL
t-yoshinaga@nanpuh.or.jp
Sponsor or person
Institute
Nanpuh hospital
Institute
Department
Personal name
Funding Source
Organization
Nanpuh hospital
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 06 | Month | 16 | 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 | 05 | Month | 12 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 16 | Day |
Last modified on
| 2019 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031822
