A human study for evaluating effectiveness and safety of barley sprout extracts consumption on alcoholic liver damage

Ewha Womans University0 个研究点目标入组 76 人开始时间: 待定最近更新: 2021年6月24日

试验速览

暂无简介。

•1) Subject who voluntarily agree to participate and signs informed consent form
•2) 20 years= Age (Ratio of men and women 1:1)
•3) Have been drinking alcohol more than a year as follows:
•- Men: more than 140g/week( about 2.5 bottle as Soju, 2.5glass/day)
•- Women: more than 70g/week( about a bottle as Soju, 1 glass/day)
•4) Comply one of the following conditions
•- more than upper llimit of AST, AST:ALT ratio is 1
•- more than upper llimit of GGT
•5) Confirmed a fatty liver

•1) Usually drinking alcohol more than 350g/week( about 6 bottles/week, 6 glasses/day)
•2) Exceed 3 times of normal upper limit more than one of the following categories: AST, ALT, GGT, total bilirubin
•3) Have anamnesis in following diseases
•? Related to liver function
•- post-transfusion hepatitis (hepatitis B surface antigen(HBsAg) or type C)
•- hepatic insufficiency, primary biliary cirrhosis
•- drug or surgery induced hepatitis
•- genetic liver disease
•? whole body infectious disease (include tuberculosis), serious cardiovascular or digestive system, thyroid disease, autoimmune disease, malignant tumor, multisystem failure, inflammatory enteropathy, a mental patient, confirmed as HIV-positive.4) Medical history of organ transplant or bone-marrow transplantation
•5) Consumption of sprout foods within 2 weeks before the first visit
•6) Consumption of prohibit drugs within 6 months before the first visit or have potential to take during the study period
•7) Continuous consumption of dietary supplement or oriental medicine or sobering drinks that affect liver function, inflammation, antioxidative capacity within 4 weeks before the first visit
•8) Subjects with hypersensitivity to test materials
•9) Participation in other human study within 4 weeks before the first visit
•10) Pregnant or lactating women
•11) Any condition that the principal investigator believes may put the subjects at undue risk

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