To evaluate the efficacy and safety of Pien Tze Huang in the treatment of Non-alcoholic steatohepatitis(damp heat and phlegm stasis syndrome): a multicenter, randomized, double-blind, placebo-co

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

(1) Accord with the diagnosis of nonalcoholic steatohepatitis;
(2) The evaluation results of liver biopsy within 6 months before randomization were as follows: The stage of liver fibrosis classified by NASH CRN was F1, F2 or F3; NAS score = 4, lobular inflammation and hepatic ballooning score = 1; (If historical biopsy is used, the weight change between biopsy time and randomization time should be = 5%; if liver biopsy is planned during screening, the weight change between screening day 1 and randomization time should be = 5%);
(3)Syndrome differentiation of traditional Chinese medicine is damp heat phlegm stasis syndrome;
(4)Age form 18 years to 65 years (including 18 and 65) , regardless of gender;
(5)Participate in this clinical trial voluntarily, give informed consent and sign informed consent.

Exclusion Criteria

(1) Excessive alcohol consumption for 3 months or more in the first year before screening (on average, men drank more than 30 grams of alcohol every day, which is equivalent to 3.75 units of alcohol, and women drank more than 20 grams, which is equivalent to 2.5 units of alcohol: 1 unit=285 mL of beer, or 25 mL of spirits, or 100 mL of wine);
(2) Liver and biliary diseases suspected to have other causes 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, cirrhosis, primary sclerosing cholangitis, Wilson's disease,a 1 - antitrypsin deficiency, liver cancer (or family history of liver cancer), etc;
(3) In the year before screening, there was more than 2 weeks of medication history (amiodarone, methotrexate, systemic glucocorticoid, tetracycline, tamoxifen, estrogen greater than hormone replacement dose, synthetic steroids, valproic acid and other known liver toxins) that could cause hepatic steatosis or steatohepatitis;
(4) Liver protecting drugs (including but not limited to reduced glutathione, glucurolactone, glycyrrhizic acid preparation, nicotinamide, diphenyl diester, liver protecting tablets, silymarin (guest), polyene phosphatidylcholine, S-adenosylmethionine, ursodeoxycholic acid, vitamin E and other Chinese herbs that affect liver function) were used within 4 weeks before enrollment;
(5)(5) At the time of randomization or in the past, patients suffered from ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis or liver transplantation, or planned liver transplantation;
(6) Type 1 diabetes;
(7) Patients with type 2 diabetes were treated with hypoglycemic drugs (except GLP-1 receptor agonist and pioglitazone) before randomization, and the dose was stable for less than 3 months;
(8) Receive GLP-1 receptor agonist and pioglitazone treatment within 90 days before enrollment (those who stop taking the drug more than 3 months before enrollment can be included);
(9) The blood pressure was not well controlled (= 160/100mmHg) with stable dose of antihypertensive drugs within 3 months before randomization;
(10) The blood lipid is abnormal, and the use of lipid-lowering drugs is unstable within 3 months before randomization (such as statins, beta drugs, niacin, coelenamine, high-purity fish oil preparations, etc.);
(11) Model for End-stage Liver Disease (MELD) score>12, or Child Turcotte Pugh (CTP) score>6;
(12) Patients who received vitamin E (dose = 300mg/day), obenzoic acid, berberine and other drugs to treat NASH for more than 1 year, or received vitamin E (dose = 300mg/day), obenzoic acid, berberine and other drugs to treat NASH within 90 days before enrollment (those who stopped taking drugs within 1 year and more than 3 months before enrollment can be selected);
(13) Have a history of weight loss surgery or plan to perform weight loss surgery (within 1 year);
(14) Body weight was unstable within 3 months before randomization (increase or decrease>5%); Use any drug with definite weight loss/weight loss effect within 3 months before randomization, such as orlistat, liraglutide, fentamine, topiramate, chlorocarselin hydrochloride, naltrexone hydrochloride, diethylamine phenylacetone, benzotriazine tartrate, etc;
(15) Myocardial infarction and unstable angina occurred within 6 months before screening, or coronary intervention (diagnostic angiography is allowed)