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NCT Number: NCT07320456

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

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.

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Key information

Conditions

Hepatic Steatosis Digestive System Diseases Fatty Liver Liver Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 not received any anti-NAFLD medication treatment in the past month;
  • Normal major organ function, including heart, kidney, and liver functions, specifically: no significant abnormalities on electrocardiogram; normal serum creatinine and urea nitrogen; normal serum bilirubin and albumin levels;
  • Has sufficient cognitive and understanding abilities to comprehend the study content and its potential risks and benefits;
  • Voluntarily participates in the study and signs an informed consent form.

Exclusion criteria

  • 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.;
  • Known allergy or intolerance to any component of the study medication;
  • Has participated in another clinical trial within the last three months;
  • Pregnant women, lactating women, or women of childbearing age who refuse to use effective contraception during the trial;
  • Has severe mental illness or behavioral disorders that may affect adherence to the study protocol;
  • Other conditions that the researcher considers unsuitable for participation in this study.

Treatment and study plan

Longqi Jiangzhi decoction

Drug

Below 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

Drug

The 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.

Primary outcomes

  1. controlled attenuation parameter

    Time frame: through study completion, an average of 8 weeks

    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.

Secondary outcomes

  1. body weight

    Time frame: through study completion, an average of 8 weeks

    weighing on a scale

  2. total cholesterol

    Time frame: through study completion, an average of 8 weeks

    serum biochemistry

  3. triglyceride

    Time frame: through study completion, an average of 8 weeks

    serum biochemistry

  4. fasting plasma glucose

    Time frame: through study completion, an average of 8 weeks

    serum biochemistry

  5. alanine aminotransferase

    Time frame: through study completion, an average of 8 weeks

    serum biochemistry

  6. aspartate aminotransferase

    Time frame: through study completion, an average of 8 weeks

    serum biochemistry

Other outcomes

  1. urea nitrogen

    Time frame: through study completion, an average of 8 weeks

    serum biochemistry

  2. creatinine

    Time frame: through study completion, an average of 8 weeks

    serum biochemistry

Sponsors and collaborators

Lead sponsor

Shanghai Municipal Hospital of Traditional Chinese Medicine

Other

Registry information

Official study title

Effect of Longqi Jiangzhi Decoction on Non-alcoholic Fatty Liver Disease: a Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 6, 2026
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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