Combination of CXD and Restrictive Ketogenic Diet Against MASLD

Phase 2Not Yet RecruitingNCT07639866

Shanghai Municipal Hospital of Traditional Chinese Medicine135 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

135

Conditions

MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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