This study will evaluate the efficacy and safety and the best effective dose of HuHuangLianzonggan capsule in subjects with nonalcoholic steatohepatitis.
Males and females between 18-75 years of age inclusive(including boundary values).
Must have had a liver biopsy proven NASH within 6 months or in screening test. The following two requirements must be met at the same time: ① a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components: Steatosis≥1, Lobular inflammation≥1, Ballooning degeneration≥1;② fibrosis stage 1 to 3.
Must have confirmation of ≥ 8% liver fat content on magnetic resonance imaging- proton density fat fraction (MRI-PDFF) at screening.
No alcohol consumption or history of excessive alcohol consumption: less than 210 g of ethanol per week for men and 140 g for women in the past 12 months.
Treatment with drugs that may cause non-alcoholic fatty liver disease (NAFLD) administered for at least 2 weeks within 12 months prior to qualifying liver biopsy (e.g. valproic acid, tamoxifen, methotrexate, amiodarone, oral corticosteroids, >5 mg/day of prednisone equivalent [one short (<2 weeks) course of oral corticosteroids, more than 3 months before the liver biopsy is allowed], or oestrogens [at doses greater than those used for contraception or hormone replacement]).
Documented causes of fatty liver disease other than NASH including, but not restricted to: HCV-associated fatty liver (genotype 3), hepatolenticular degeneration, autoimmune hepatitis, total parenteral nutrition, abetalipoproteinemia, lipoatrophy , Coeliac disease, Primary sclerosing cholangitis, Alpha-1-antitrypsin deficiency, Drug-induced liver disease.
Model for End-stage Liver Disease (MELD) score >12.
Histologically documented liver cirrhosis (fibrosis stage F4), history or current diagnosis of hepatocellular carcinoma HCC.