A 12 week, double-blind, randomized, placebo-controlled clinical trial for the evaluation of the efficacy and safety of IBT-Pr on improving liver function

Insect Biotch0 个研究点目标入组 80 人开始时间: 待定最近更新: 2019年5月20日

适应症

试验速览

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•1) Male and female subject aged between 20 years and 75 years
•2) Subject with abnormal serum AST(GOT) level 45-135U/L or ALT(GPT) level 40-120U/

•1) Subject who are taking treatment(hospitalization, medication, rehabilitation) due to alcohol abuse, alcohol-related disease, heart disease and central nervous disorder
•2) Subject with liver cirrhosis or hepatoma on ultrasonography
•3) During the past one month in the drinking habit survey, more than the average male in a week 14unit, female in a week 7unit
•4) Subjects with ?-GTP(Gamma Glutamyl Transpeptidase) = the upper limit of normal levels(ULN)?4
•5) ALP = the upper limit of normal levels(ULN)?3 or Platelet = Platelet 105/µL or AFP > 20ng/mL
•6) Subject who currently diagnosed with viral hepatitis
•7) Subject who has positive with HBs Ag or HCV Ab in screening
•8) Albumin = 3.5g/dl or Total Bilirubin = 3mg/dl
•9) Subject who took a medication that affects the liver funtion, Cholagogues, Cholelitholytics, Hepatic Protectors, Antidotes, Detoxifying Agents & Drugs Used in Substance Dependence, adrenal cortical hormone or sex hormone within 4 weeks
•10) Subject who took an antiviral agent, antibiotics, oriental medicine, vitamine E supplement or health functional food related with liver function improvement within 2weeks

发起方

Insect Biotch