Unique ID issued by UMIN | UMIN000021816 |
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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 | 2017/07/11 09:20:32 |
The effect of polymethoxy flavonoid on a liver function,sugar,lipid metabolism and obesity.Randomized Control Trial
The study of effectiveness of Polymethoxy flavonoid
The effect of polymethoxy flavonoid on a liver function,sugar,lipid metabolism and obesity.Randomized Control Trial
The study of effectiveness of Polymethoxy flavonoid
Japan |
Borderline of Fatty liver
Medicine in general | Hepato-biliary-pancreatic surgery | Adult |
Others
YES
To evaluate of polymethoxy flavonoid on a liver function,sugar,lipid metabolism and obesity.
Safety,Efficacy
AST, ALT,gammaGTP,QOL
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
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
One Capsule a day which contain 2mg of polymethoxy flavonoid
One Capsule a day which contain no polymethoxy flavonoid
20 | years-old | <= |
75 | years-old | > |
Male and Female
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.
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.
44
1st name | |
Middle name | |
Last name | Tsugutami Onodera |
Sapporo Yurinokai Hospital
The director of the hospital
Yurigahara11-186, kita-ku, Sapporo , Hokkaido
011-771-1501
takahashi@yurinokai.jp
1st name | |
Middle name | |
Last name | Hirosato Kawakami |
Karada Lab, Inc.
The Director of the Laboratory
Yousuien-nai, 59 Gansuin-cho, Kamigyo-ku, Kyoto 602-0008, JAPAN
050-5536-5694
kawakamih@arkray.co.jp
ARKRAY, Inc.
ARKRAY, Inc.
Self funding
NO
2016 | Year | 04 | Month | 08 | Day |
Unpublished
Completed
2016 | Year | 03 | Month | 28 | Day |
2016 | Year | 04 | Month | 27 | Day |
2016 | Year | 04 | Month | 07 | Day |
2017 | Year | 07 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025157
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