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Not yet recruiting NCT07320456

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

Phase II Interventional Hepatic Steatosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Longqi Jiangzhi decoction, Control placebo.
Who it may be relevant to
Registry conditions: Hepatic Steatosis. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Longqi Jiangzhi decoction
    Below is the composition of Longqi Jiangzhi decoction: Gentiana Scabra 5g, Astragalus membranaceus 10g, Rhizoma Alismatis 10g, Crataegus pinnatifida 10g, Citri Reticulatae Pericarpium 5g.
  • Drug Control placebo
    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 outcome measures

  • controlled attenuation parameter [Time frame: through study completion, an average of 8 weeks]
Secondary outcome measures (6)
  • body weight [Time frame: through study completion, an average of 8 weeks]
  • total cholesterol [Time frame: through study completion, an average of 8 weeks]
  • triglyceride [Time frame: through study completion, an average of 8 weeks]
  • fasting plasma glucose [Time frame: through study completion, an average of 8 weeks]
  • alanine aminotransferase [Time frame: through study completion, an average of 8 weeks]
  • aspartate aminotransferase [Time frame: through study completion, an average of 8 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07320456 · LJD2025001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗