UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021816 |
|---|---|
| Receipt number | 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 | 2024/05/17 15:32:48 |
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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'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
Name of lead principal investigator
| 1st name | Tsugutami |
| Middle name | |
| Last name | Onodera |
Organization
Sapporo Yurinokai Hospital
Division name
The director of the hospital
Zip code
002-8081
Address
Yurigahara11-186, kita-ku, Sapporo , Hokkaido
TEL
011-771-1501
takahashi@yurinokai.jp
Public contact
Name of contact person
| 1st name | Hirosato |
| Middle name | |
| Last name | Kawakami |
Organization
Karada Lab, Inc.
Division name
The Director of the Laboratory
Zip code
602-0008
Address
Yousuien-nai, 59 Gansuin-cho, Kamigyo-ku, Kyoto 602-0008, JAPAN
TEL
050-5536-5694
Homepage URL
kawakamih@arkray.co.jp
Sponsor or person
Institute
ARKRAY, Inc.
Institute
Department
Personal name
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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.co.jp
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
| 2024 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025157
