Combination of CXD and Restrictive Ketogenic Diet Against MASLD

NCT07639866 | Not Yet Recruiting Phase 2

• 1 other identifier: KD20260527
• Study Type: interventional
• Target: 135
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• BMI

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

• Triglyceride(TG)

  From enrollment to the end of treatment at 8 weeks

• Total blood cholesterol(TC)

  From enrollment to the end of treatment at 8 weeks

• High-Density Lipoprotein(HDL)

  From enrollment to the end of treatment at 8 weeks

• Alanine Aminotransferase (ALT)

  From enrollment to the end of treatment at 8 weeks

Study Arms (3)

Low-carbon control group

PLACEBO COMPARATOR

Dietary Supplement: Low-carbon control group

KD group

EXPERIMENTAL

Dietary Supplement: KD group

CXD and KD group

EXPERIMENTAL

Drug: CXD and KD group

Interventions

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).

KD group

Low-carbon control group DIETARY_SUPPLEMENT

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

Low-carbon control group

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.

CXD and KD group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Municipal Hospital of Traditional Chinese Medicine: lead

Central Study Contacts

li xing wu

CONTACT

86 15856953935; wuxingliwxl@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 10, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 28, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 14, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share