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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021816
Receipt No. R000025157
Scientific Title The effect of polymethoxy flavonoid on a liver function,sugar,lipid metabolism and obesity.Randomized Control Trial
Date of disclosure of the study information 2016/04/08
Last modified on 2017/07/11

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Basic information
Public title The effect of polymethoxy flavonoid on a liver function,sugar,lipid metabolism and obesity.Randomized Control Trial
Acronym The study of effectiveness of Polymethoxy flavonoid
Scientific Title The effect of polymethoxy flavonoid on a liver function,sugar,lipid metabolism and obesity.Randomized Control Trial
Scientific Title:Acronym The study of effectiveness of Polymethoxy flavonoid
Region
Japan

Condition
Condition Borderline of Fatty liver
Classification by specialty
Medicine in general Hepato-biliary-pancreatic surgery Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To evaluate of polymethoxy flavonoid on a liver function,sugar,lipid metabolism and obesity.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes AST, ALT,gammaGTP,QOL
Key secondary outcomes BMI, percent of body fat, girth of the abdomen, quantity of muscle, HOMA-IR, acylglycerol, total cholesterol HDL cholesterol, LDL cholesterol, blood sugar level, HbA1c, insulin, sLOX-1, cys-TTR, arteriosclerosis index, nonHDL cholesterol, genetic test,ferritin,type4-collagen7S

Base
Study type Interventional

Study design
Basic design Parallel
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 One Capsule a day which contain 2mg of polymethoxy flavonoid
Interventions/Control_2 One Capsule a day which contain no polymethoxy flavonoid
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1)Japanese healthy volunteer (20<=age<75, male and female)
2)borderline of fatty liver
3)Those who are suitable for this trial by doctor decision.
4)Those Who can ingest the test food during the trial
5) Those who continue one&#39;s excise and/or diet therapy if needed.
6) Those who can give informed consent by the document.
Key exclusion criteria 1)Viral hepatitis patient, alcoholic hepatitis patient, autoimmune liver damage patient
2)BMI>=30
3)Heart failure, myocardial infarction with a history of the past of the treatment
4)Those who takes medicine for antihypertensive drug, lipidosis symptom therapeutic drug, diabetes therapeutic drug, livers
5)Those who are under treatment for atrial fibrillation, arrhythmia, a liver damage, a renal damage, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, high blood pressure
5)Those who suffer any severe disease diagnosised by the responsible doctor.
6) Those who drink more than 20 grams alcohol a day everyday (beer 500 ml or sake around 1 go)
7) Those who takes a supplement regularly.
8) Those who have food allergy.
9) Those who is in breast-feeding or pregnancy, or wishes to become pregnant during the study period.
10) Those who had participated in a clinical trial within 30 days before a screening test.
11) Those who is judged as ineligible by principal investigators or researchers.
Target sample size 44

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Tsugutami Onodera
Organization Sapporo Yurinokai Hospital
Division name The director of the hospital
Zip code
Address Yurigahara11-186, kita-ku, Sapporo , Hokkaido
TEL 011-771-1501
Email takahashi@yurinokai.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Hirosato Kawakami
Organization Karada Lab, Inc.
Division name The Director of the Laboratory
Zip code
Address Yousuien-nai, 59 Gansuin-cho, Kamigyo-ku, Kyoto 602-0008, JAPAN
TEL 050-5536-5694
Homepage URL
Email kawakamih@arkray.co.jp

Sponsor
Institute ARKRAY, Inc.
Institute
Department

Funding Source
Organization ARKRAY, Inc.
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 04 Month 08 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 03 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 27 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 04 Month 07 Day
Last modified on
2017 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025157

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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