Clinical Trial Study on the Combination of CXD and Restrictive Ketogenic Diet in Treating MASLD
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 135
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Low-carbon control group
干预措施: Low-carbon control group (Dietary Supplement)
KD group
干预措施: KD group (Dietary Supplement)
CXD and KD group
干预措施: CXD and KD group (Drug)