Efficacy and Safety of Oltipraz in the Patients With Non-alcoholic Fatty Liver Disease

Exclusion Criteria

• •Over 2 ratio of AST to ALT
• •Type 1 diabetes mellitus (insulin-dependent diabetes mellitus)
• •Disorder in liver function with an exception of non-alcoholic fatty liver (e.g. Virus infection, biliary atresia, autoimmune hepatitis and etc.)
• •Patients who have been taken drugs induced fatty liver for over 3 month within 1 year of participation in this study; amiodarone, tamoxifen, methotrexate, tetracyclines, glucocorticoids, anabolic steroids, over usual dose of estrogen for hormone replacement therapy and valproate
• •Patients who has been taken any medications that could affect the treatment for non-alcoholic steatohepatitis: insulin, insulin sensitizer(metformin, thiazolidinedione), high dose of vitamin E, high dose of UDCA, pentoxifylline, SAM-e, Betaine, types of Statin, types of fibrate and orlistat
• •Patients who had a Bariatric surgery less than 6 month prior to the participation in the study
• •Patients who are judged by investigator that participation of the study is difficult due to disease as follow; hepatic cirrhosis, Wilson's disease, malignant tumor, serious metabolic disease, severe renal disease, severe pulmonary disease, severe cardiovascular disease, severe nervous disease/psychiatric disorder, muscle disease and etc
• •Any history of immune disorder which affect the changes in cytokine:
• •inflammatory bowel disease, autoimmune thrombocytopenic purpura, system lupus erythematosus, autoimmune hemolytic anemia, severe psoriasis, rheumatic arthritis and etc
• •Patients who have received treatment that may affect liver function within 1 month prior to the participation in the study
• •Patient who has been administered other investigational product within 1 month prior to the participation in the study
• •Patient who is not allowed to get MRS test: pacemaker, shunt and etc
• •Pregnant or nursing women
• •Patient who considered ineligible for participation in the study as Investigator's judgment