The goal of this clinical trial is to learn if Longqi Jiangzhi decoction works to treat non-alcoholic fatty liver disease in adults. It will also learn about the safety of drug Longqi Jiangzhi decoction. Researchers will compare drug Longqi Jiangzhi decoction to a placebo (a look-alike substance that contains no drug) to see if drug Longqi Jiangzhi decoction works to treat non-alcoholic fatty liver disease. Participants will: Take drug Longqi Jiangzhi decoction or a placebo every day for eight weeks Keep a record of their symptoms and the degree of hepatic steatosis before and after the treatment.
Age 18-50 years, both genders eligible;
Meets the diagnostic criteria for NAFLD;
Meets the diagnostic criteria for Traditional Chinese Medicine Spleen Deficiency and Damp-Heat Syndrome;
Has significant risk factors: CAP≥238dB/m, Body Mass Index (BMI) ≥23 kg/m²;
Has liver steatosis due to other definitive causes, such as alcoholic liver disease, drug-induced liver injury, viral hepatitis infections (e.g., hepatitis B, hepatitis C, etc.);
Has other serious liver diseases, such as autoimmune liver diseases, primary biliary cholangitis, Wilson's disease, etc.;
Has severe dysfunction of major organs such as the heart, kidneys, lungs, etc., such as severe heart failure (NYHA functional classification III or above), renal failure (glomerular filtration rate eGFR < 30 mL/min/1.73m²), acute exacerbation of chronic obstructive pulmonary disease, etc.;
Has other serious systemic diseases, such as malignant tumors, active systemic lupus erythematosus, etc.;
Parallel
Longqi Jiangzhi decoction
DrugBelow is the composition of Longqi Jiangzhi decoction: Gentiana Scabra 5g, Astragalus membranaceus 10g, Rhizoma Alismatis 10g, Crataegus pinnatifida 10g, Citri Reticulatae Pericarpium 5g.
Control placebo
DrugThe control placebo is a ten-fold dilution of the Longqi Jiangzhi decoction, supplemented with colorants and bittering agents to mimic the appearance and color of the treatment drug.
controlled attenuation parameter
A liver fiber diagnostic instrument (Fibro Touch) is used to perform instantaneous elastic hardness testing. The controlled attenuation parameter usually represents liver fat content, whereas higher scores mean a worse outcome.
body weight
weighing on a scale
total cholesterol
serum biochemistry
triglyceride
serum biochemistry
fasting plasma glucose
serum biochemistry
urea nitrogen
serum biochemistry
creatinine
serum biochemistry
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