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NCT07639866
Combination of CXD and Restrictive Ketogenic Diet Against MASLD
Conditions: MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
Sex: All
Ages: 18 Years – 50 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 135
Sponsor: Shanghai Municipal Hospital of Traditional Chinese Medicine
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.
Eligibility Criteria
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 \
Source: ClinicalTrials.gov (NCT07639866). StuddyBuddy aggregates publicly available trial information.