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NCT Number: NCT07639866

Combination of CXD and Restrictive Ketogenic Diet Against MASLD

This study employed a single-center, randomized, investigator-blind, three-group parallel, stepwise controlled clinical trial. A total of 135 subjects were randomly assigned to receive either a low-carbohydrate diet intervention, a restrictive ketogenic diet intervention, or a decoction preparation of the Tucha Lipid-Reducing Formula combined with a restrictive ketogenic diet. The trial duration consisted of 8 weeks of treatment followed by 8 weeks of follow-up. During the trial, participants adhered to dietary calorie control and moderate exercise as instructed in health education, self-reported their height, weight, waist-to-hip ratio, and other general parameters, and had weekly blood ketone level monitoring. Liver ultrasound, fasting blood glucose, lipid profiles, blood ketones, liver function tests, serum creatinine, urea nitrogen levels, and scores on the Traditional Chinese Medicine Syndrome Scale were measured before treatment initiation and at the end of the 8-week treatment period.

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Key information

Conditions

MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)

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, regardless of gender
  • Meet the diagnostic criteria for MASLD
  • Meet the diagnostic criteria for dampness-heat accumulation syndrome in Traditional Chinese Medicine
  • Liver controlled attenuation parameter (CAP) ≥238 dB/m
  • Body mass index (BMI) ≥23 kg/m²
  • Possess adequate cognitive and comprehension abilities to understand the study content, its potential risks, and benefits;
  • Voluntarily participate in this study and personally sign the informed consent form

Exclusion criteria

  • Concurrent presence of other liver diseases that may lead to hepatic steatosis, specifically including drug-induced liver injury, alcoholic liver disease, autoimmune liver disease, viral hepatitis, and Wilson's disease
  • Concurrent severe dysfunction of major organs such as the heart, kidneys, or lungs, e.g., severe cardiac insufficiency (NYHA class III or higher), renal failure (estimated glomerular filtration rate <30 mL/min/1.73 m²), or acute exacerbation of chronic obstructive pulmonary disease
  • Subjects currently receiving treatment for MASLD
  • Concurrent presence of other severe systemic diseases, such as malignant tumors or active systemic lupus erythematosus
  • Known hypersensitivity or intolerance to any component of the study drug
  • Pregnant women, lactating women, or women of childbearing age who refuse effective contraceptive measures during the trial
  • Participation in other clinical trials within the past 3 months
  • Other circumstances deemed by the investigator unsuitable for participation in this study, such as severe mental disorders affecting compliance with the study

Treatment and study plan

Low-carbon control group

Dietary Supplement

The control group received a standardized low-carbohydrate diet (carbohydrates accounted for 25%-30% of total caloric intake).

KD group

Dietary Supplement

Daily carbohydrate intake should not exceed 5%, with three consecutive ketogenic days per week implemented (selected according to the subject's preference).

CXD and KD group

Drug

In addition to a restrictive ketogenic diet intervention, the patients were administered a traditional Chinese medicine compound formula named Chazhu Xiaoli Formula for lipid reduction. 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.

Primary outcomes

  1. Controlled Attenuation Parameter (CAP) value

    Time frame: From enrollment to the end of treatment at 8 weeks

    Use an elastography ultrasound device to measure liver fat content

Secondary outcomes

  1. BMI

    Time frame: From baseline to the end of the 8-week follow-up period

  2. Triglyceride(TG)

    Time frame: From enrollment to the end of treatment at 8 weeks

    Use a fully automated biochemical analyzer to measure TG

  3. Total blood cholesterol(TC)

    Time frame: From enrollment to the end of treatment at 8 weeks

    Use a fully automated biochemical analyzer to measure TC

  4. High-Density Lipoprotein(HDL)

    Time frame: From enrollment to the end of treatment at 8 weeks

    Use a fully automated biochemical analyzer to measure HDL

  5. Alanine Aminotransferase (ALT)

    Time frame: From enrollment to the end of treatment at 8 weeks

    Use a fully automated biochemical analyzer to measure liver function

  6. Aspartate Aminotransferase(AST)

    Time frame: From enrollment to the end of treatment at 8 weeks

    Use a fully automated biochemical analyzer to measure liver function

  7. Gamma-Glutamyl Transferase(GGT)

    Time frame: From enrollment to the end of treatment at 8 weeks

    Use a fully automated biochemical analyzer to measure liver function

  8. Blood glucose metabolism indicators

    Time frame: From enrollment to the end of treatment at 8 weeks

    Use a fully automated biochemical analyzer to measure blood glucose

  9. Traditional Chinese Medicine Syndrome Scoring System

    Time frame: From enrollment to the end of treatment at 8 weeks

    The title is Traditional Chinese Medicine Syndrome Scale. The minimum score is 0 and the maximum is 6. Lower scores indicate better results.

  10. Blood ketones

    Time frame: From baseline to the end of the 8-week follow-up period

    Use a fully automated biochemical analyzer to measure blood ketones to indicate clinical safety

  11. Creatinine

    Time frame: From enrollment to the end of treatment at 8 weeks

    Use a fully automated biochemical analyzer to measure creatinine to indicate clinical safety

  12. Blood Urea Nitrogen

    Time frame: From enrollment to the end of treatment at 8 weeks

    Use a fully automated biochemical analyzer to measure blood urea nitrogen to indicate clinical safety

Study contacts

Contact information is provided by the study sponsor or research team.

li xing wu

CONTACT

[email protected]

86 15856953935

Sponsors and collaborators

Lead sponsor

Shanghai Municipal Hospital of Traditional Chinese Medicine

Other

Registry information

Official study title

Clinical Trial Study on the Combination of CXD and Restrictive Ketogenic Diet in Treating MASLD

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 10, 2026
Registry last updated
Jul 14, 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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