Combination of CXD and Restrictive Ketogenic Diet Against MASLD

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

Study Overview

• Status: Not yet recruiting
• Conditions: MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
• Intervention / Treatment: Dietary supplement: Low-carbon control group; Dietary supplement: KD group; Drug: CXD and KD group

• Study Type: Interventional
• Enrollment (Estimated): 135
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: li xing wu; Phone Number: 86 15856953935; Email: wuxingliwxl@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Low-carbon control group	Dietary supplement: Low-carbon control group; The control group received a standardized low-carbohydrate diet (carbohydrates accounted for 25%-30% of total caloric intake).
Experimental: KD group	Dietary supplement: KD group; Daily carbohydrate intake should not exceed 5%, with three consecutive ketogenic days per week implemented (selected according to the subject's preference).
Experimental: CXD and KD group	Drug: CXD and KD group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Controlled Attenuation Parameter (CAP) value	Use an elastography ultrasound device to measure liver fat content	From enrollment to the end of treatment at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI		From baseline to the end of the 8-week follow-up period
Triglyceride(TG)	Use a fully automated biochemical analyzer to measure TG	From enrollment to the end of treatment at 8 weeks
Total blood cholesterol(TC)	Use a fully automated biochemical analyzer to measure TC	From enrollment to the end of treatment at 8 weeks
High-Density Lipoprotein(HDL)	Use a fully automated biochemical analyzer to measure HDL	From enrollment to the end of treatment at 8 weeks
Alanine Aminotransferase (ALT)	Use a fully automated biochemical analyzer to measure liver function	From enrollment to the end of treatment at 8 weeks
Aspartate Aminotransferase(AST)	Use a fully automated biochemical analyzer to measure liver function	From enrollment to the end of treatment at 8 weeks
Gamma-Glutamyl Transferase(GGT)	Use a fully automated biochemical analyzer to measure liver function	From enrollment to the end of treatment at 8 weeks
Blood glucose metabolism indicators	Use a fully automated biochemical analyzer to measure blood glucose	From enrollment to the end of treatment at 8 weeks
Traditional Chinese Medicine Syndrome Scoring System	The title is Traditional Chinese Medicine Syndrome Scale. The minimum score is 0 and the maximum is 6. Lower scores indicate better results.	From enrollment to the end of treatment at 8 weeks
Blood ketones	Use a fully automated biochemical analyzer to measure blood ketones to indicate clinical safety	From baseline to the end of the 8-week follow-up period
Creatinine	Use a fully automated biochemical analyzer to measure creatinine to indicate clinical safety	From enrollment to the end of treatment at 8 weeks
Blood Urea Nitrogen	Use a fully automated biochemical analyzer to measure blood urea nitrogen to indicate clinical safety	From enrollment to the end of treatment at 8 weeks

Collaborators and Investigators

• Sponsor: Shanghai Municipal Hospital of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 28, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: June 6, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 6, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: KD20260527

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No