UMIN-CTR Clinical Trial

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
Email	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
Email	t-yoshinaga@nanpuh.or.jp

Sponsor
Institute	Nanpuh hospital
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031822