Cirrhosis
Conditions
Interventions
Experimental Group:Oral, Fuzheng Huayu tablets, 4 tablets each time, 3 times daily.
Control Group:Fuzhenghua Yu tablet simulant, 4 tablets per dose, 3 times daily.
Sponsors
Shanghai Jiao Tong University School of Medicine Affiliated Xinhua Hospital Affiliated Xinhua Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 75 years old (inclusive of both lower and upper limits). 2. Metabolic Dysfunction-Associated Fatty Liver Cirrhosis (Compensated Stage), meeting all three criteria below: (1) Liver Stiffness Measurement (LSM) =20 kPa by FibroScan® at screening; OR LSM =15 kPa plus any one of the following indicators: platelet count <150×10/L, or FIB-4 index =3.48, or Agile4 score =0.57. (2) Medical history of metabolic dysfunction or Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD). (3) Child-Turcotte-Pugh score for liver function <7 points and Model for End-Stage Liver Disease (MELD) score <12 points. 3. Voluntarily participate in this clinical trial and sign the written informed consent form.
Exclusion criteria
Exclusion criteria: 1. History or current hepatic decompensation events at screening, including but not limited to the following: a) Esophagogastric variceal bleeding; b) Hepatic ascites requiring diuretic treatment; c) Hepatic encephalopathy (West Haven grade 2 or above); d) Hepatorenal syndrome. 2. Having a history or evidence of other chronic liver diseases, such as alcoholic liver disease, drug-induced liver disease, primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis or overlap syndrome, Wilson's disease, alpha-1 antitrypsin deficiency, hereditary hemochromatosis, history of biliary obstruction or biliary shunt, metastatic liver cancer; Hepatitis B (HBsAg positive); Hepatitis C (HCV antibody positive and HCV-RNA positive). Subjects with previous hepatitis C treatment must maintain negative HCV-RNA results for at least 3 years before screening to be eligible. 3. History of liver transplantation, on the liver transplantation waiting list, or history of TIPS operation. 4. Use of anti-obesity drugs within 3 months prior to screening and during the whole trial is prohibited, including bupropion-naltrexone, orlistat, phentermine, phentermine/topiramate and anti-obesity supplements. Subjects planning to receive metabolic bariatric surgery during the study will be excluded (excluding acupuncture weight loss, liposuction or abdominal lipectomy performed more than 1 year before screening). 5. Type 1 diabetes mellitus; uncontrolled type 2 diabetes mellitus, defined as HbA1c > 9% at screening or within 60 days before randomization. Subjects with HbA1c > 9% may be re-screened once no less than 3 months after the initial screening failure; insulin dosage adjustment more than 20% within 60 days before randomization is also excluded. 6. Unstable use of drugs that may affect efficacy evaluation within 3 months prior to screening, including but not limited to Vitamin E (dose > 400 IU/d), thiazolidinediones (TZDs), SGLT-2 inhibitors, GLP-1 receptor agonists, and chiglitazar. Those who have taken stable dosage continuously until screening visit and will maintain relatively stable dosage throughout the study period are allowed to enroll. 7. Use of drugs that may induce hepatic steatosis or steatohepatitis for at least 4 weeks within 6 months prior to screening (e.g., valproic acid, tamoxifen, methotrexate, amiodarone, long-term oral corticosteroids > 5 mg/d prednisone equivalent, or estrogen at doses higher than contraception or hormone replacement therapy). The above drugs are prohibited throughout the trial until the end of follow-up. Subjects requiring bronchodilators, topical, inhaled, nasal corticosteroids or caudal steroid injections are not excluded. 8. Use of Chinese herbal medicine and proprietary Chinese medicines with anti-fibrotic or MAFLD therapeutic effects within 3 months prior to screening, including but not limited to Compound Biejia Ruangan Capsules, Anluo Huaxian Pills, Qianggan Capsules/Tablets. If the medication course is no more than 3 months, subjects can be enrolled after a 1-month washout period. 9. Uncontrolled hypertension at screening, defined as systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg. 10. Occurrence of myocardial infarction, unstable angina, malignant arrhythmia, percutaneous coronary intervention, coronary artery bypass grafting, ischemic or hemorrhagic stroke, transient ischemic attack, acute peripheral vascular events within 6 months prior to screening. 11. Active severe disea
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver stiffness value; | — |
Countries
China
Contacts
Public ContactFan Jian Gao
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine ( / )
Outcome results
None listed