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NCT Number: NCT06442137

A Clinical Trial of Chazhu Xiaozhi Decoction Against Non-alcoholic Fatty Liver Disease

The goal of this clinical trial is to learn if drug Chazhu Xiaozhi decoction works to treat non-alcoholic fatty liver disease in adults. It will also learn about the safety of drug Chazhu Xiaozhi decoction. The main questions it aims to answer are:

Does drug Chazhu Xiaozhi decoction improve the degree of hepatic steatosis in patients with non-alcoholic fatty liver disease? What medical problems do participants have when taking drug Chazhu Xiaozhi decoction? Researchers will compare drug Chazhu Xiaozhi decoction to a placebo (a look-alike substance that contains no drug) to see if drug Chazhu Xiaozhi decoction works to treat non-alcoholic fatty liver disease.

Participants will:

Take drug Chazhu Xiaozhi 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 Pathological Conditions, Signs and Symptoms Signs and Symptoms Symptoms and Signs

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shanghai Municipal Hospital of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200071, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

According to the diagnostic criteria, patients with NAFLD and Spleen Deficiency and Damp-Heat Syndrome are selected. The specific criteria are as follows:

  • 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

Chazhu Xiaozhi decoction

Drug

Below is the composition of Chazhu Xiaozhi decoction: Camellia Sinensis Radix 15g, Atractylodis Rhizoma 15g, Herba Gynostemmatis Pentaphylli 15g, Ilicis Cornutae Folium 15g, Alismatis Rhizoma 9g, Nelumbinis Folium 6g, Crataegi Fructus 6g, Polygoni Orientalis Fructus 3g.

Control placebo

Drug

The control placebo is a ten-fold dilution of the Chazhu Xiaozhi 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.

  2. traditional Chinese medicine syndrome scale

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

    The traditional Chinese medicine syndrome scale includes evaluations of symptoms such as discomfort in the right flank, bloating in the epigastric region, bitter mouth, dry mouth, loose and loose stools, fatigue and fatigue throughout the body, loss of appetite, nausea, dizziness, and yellow urine, with a score range from 0 to 3, and 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. body mass index

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

    calculate

  3. fasting blood glucose

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

    serum biochemistry

  4. alanine aminotransferase

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

    serum biochemistry

  5. aspartate transaminase

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

    serum biochemistry

  6. γ-glutamyl transpeptidase

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

    serum biochemistry

  7. triglyceride

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

    serum biochemistry

  8. total cholesterol

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

    serum biochemistry

  9. creatinine

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

    serum biochemistry

  10. urea nitrogen

    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 Chazhu Xiaozhi Decoction on Non-alcoholic Fatty Liver Disease: a Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jun 4, 2024
Registry last updated
Apr 3, 2025

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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