A Clinical Trial of Longqi Jiangzhi Decoction Against Non-alcoholic Fatty Liver Disease

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-50
SponsorShanghai Municipal Hospital of Traditional Chinese Medicine

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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.;

Trial design

Treatments tested in this trial

  • Longqi Jiangzhi decoction
  • Control placebo

Treatment groups

80 Participants
are divided into 2 treatment groups

Locations

This trial has no locations