Non-alcoholic steatohepatitis
Conditions
Interventions
Treatment group:Shugan Xiaozhi decoction + behavioral intervention therapy
Control group:Vitamin E + behavioral intervention therapy
Sponsors
Department of Hepatology, Shenzhen Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Consistent with the diagnosis of non-alcoholic steatohepatitis; The liver biopsy evaluation results within 6 months before randomization were: The liver fibrosis stage classified by NASH SAF was F1-F2 or F3; The S score is =1, the A score is =1, and both the lobular inflammation and hepatocyte balloon-like degeneration scores are =1. If historical biopsy is used, the weight change between the biopsy time and the randomization time should be =5%. If liver biopsy is planned during the screening period, the weight change between the first day of screening and the randomization time should be =5%. The detection of liver fat fraction =5% measured by MMRI -PDFF during screening, liver stiffness >6.0Kpa measured by FibroScan, and MREC value; (2) The diagnosis in traditional Chinese medicine is damp-heat syndrome of the liver and gallbladder. Age: 18 to 65 years old (inclusive), gender not limited. Voluntarily participate in this clinical trial, give informed consent and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: (1) Excessive alcohol consumption for three consecutive months or more within one year prior to screening (men consume an average of over 30 grams of ethanol per day, equivalent to 3.75 units of alcohol, and women consume over 20 grams, equivalent to 2.5 units of alcohol: 1 unit = 285mL of beer, or 25mL of spirits, or 100 ml of wine); (2) Other liver and biliary diseases suspected through medical history and laboratory tests, including but not limited to: hepatitis B or C virus infection, alcoholic liver disease, drug-induced liver disease, autoimmune hepatitis, liver cirrhosis, primary sclerosing cholangitis, Wilson's disease, a 1-antitrypsin deficiency, liver cancer, etc. (3) Within one year prior to screening, there was a medication history of more than two weeks that could cause hepatic steatosis or steatohepatitis (amiodarone, methotrexate, systemic glucocorticoids, tetracycline, tamoxifen, estrogen at doses greater than hormone replacement, synthetic steroids, valproic acid, and other known liver toxins); (4) Drugs that affect the therapeutic effect evaluation were used within two weeks before screening, such as liver-protecting drugs (including but not limited to reduced glutathione, gluconolactone, glycyrrhizic acid preparations, ursodeoxycholic acid, nicotinamide, biphenyl diester, liver-protecting tablets, silymarin (bin), polyene phosphatidylcholine, S-adenosylmethionine and other Chinese herbal medicines that affect liver function, etc.); (5) Imaging examination (MRE=2.03m/s, which is the optimal value for the previous assessment) suggests liver cirrhosis; And at randomization or in the past, having ascites, varicose vein hemorrhage, hepatic encephalopathy, spontaneous bacterial peritonitis or liver transplantation, or planning to undergo liver transplantation; The ModelforEnd-stageLiverDisease (MELD) score is greater than 12 points, and the Child-Turcotte-Pugh (CTP) score for liver function is greater than 6 points. (6) Combined with type 1 diabetes; Patients with type 2 diabetes mellitus were treated with metformin, sulfonylureas or a -glycosidase inhibitors before randomization, with a stable dose of less than 3 months. (7) Poor blood pressure control (=160/100 MMHG) was treated with a stable dose of antihypertensive drugs within 3 months prior to random enrollment; (8) Dyslipidemia, unstable use of lipid-lowering drugs within 3 months before random enrollment (such as statins, fibrates, niacin, corolenamide, high-purity fish oil preparations, etc.); (9) Hypothyroidism is not controlled (thyroid stimulating hormone >2 times ULN); (10) Those who have received vitamin E (dose =800IU/ day), obeticholic acid, berberine, pioglitazone, angiotensin receptor antagonists or approved drugs for the treatment of NASH within 90 days before screening (those who have stopped taking the drugs more than 3 months before screening can be included); (11) Have a history of bariatric surgery or plan to undergo such surgery within one year; (12) Unstable weight (increase or decrease >5%) within 3 months prior to randomization; (13) During the screening period, baseline BMI=35kg/m ²; (14) Those who have experienced myocardial infarction, unstable angina pectoris within 6 months prior to screening, or have undergone coronary intervention (diagnostic angiography is allowed) or vascular transplantation within 6 months, or have a New York Cardiac Function Classification (NYHA) grade III or above; (15) Combined with severe primary diseases of the blo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FibroScan: CAP value, LSM value;Liver biopsy pathology: F, A, S grades;CK18 (M30/M65) concentration value;Magnetic resonance elastography (MRE) data; | — |
Secondary
| Measure | Time frame |
|---|---|
| Body Mass Index (BMI);Liver function (ALT, AST, GGT); | — |
Countries
China
Contacts
Public ContactGuangdong Tong
Department of Hepatology, Shenzhen Traditional Chinese Medicine Hospital
Outcome results
None listed