Re Evaluation of the Clinical Efficacy of Ganzhixiao Capsules Based on MRI-PDFF in the Treatment of Metabolic Related Fatty Liver Disease
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 138
- 主要终点
- MRI-PDFF
研究概览
简要总结
This trial is expected to enroll 138 MAFLD patients in one clinical center, who will be randomly divided into a placebo group and a Ganzhixiao capsule group in a 1:1 ratio. There will be 69 patients in the Ganzhixiao group and 69 patients in the placebo group. Administer Ganzhixiao capsules or mimetics separately, intervene for 16 weeks, and compare the liver fat content、 ALT、 Changes in indicators such as cytokeratin 18 fragment, FIB-4 score, and LSM score. Among them, MRI-PDFF is the main efficacy evaluation index to evaluate the clinical efficacy of Ganzhixiao capsules in the treatment of MAFLD.
详细描述
All participants in the trial were required to have a low-fat diet and engage in aerobic exercise for 150 minutes per week.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 70 years old, with a body mass index (BMI) of at least 24kg/m2;
- •Diagnosis of NAFLD determined by imaging [ultrasound, computed tomography or magnetic resonance imaging (MRI-PDFF)] or liver biopsy, showing MAFLD or simple steatosis within the last 24 months prior to screening;
- •MAFLD patients conform to the damp heat syndrome type; ④ Voluntary signing of informed consent form
排除标准
- •Blood biochemical indicators ALT, AST, BUN are greater than 1.5 times the upper limit of normal values, Cr is greater than the upper limit of normal values, eGFR<60ml/min/1.73m2;
- •Alcoholic fatty liver, other chronic liver diseases, cirrhosis, liver malignant tumors, etc.;
- •Type 2 diabetes and pancreatic diseases;
- •Taking some hypoglycemic, lipid-lowering, liver protective drugs or high-dose vitamin E that may affect the efficacy judgment in the past three months;
- •Patients with severe infections, cardiovascular, respiratory, renal, hematological, rheumatic connective tissue disease, neuropsychiatric, and non liver malignant tumors;
- •Pregnant or lactating women;
- •Those who require long-term hormone therapy;
- •Researchers anticipate poor compliance or inability to cooperate;
- •There are contraindications for MRI examination, including pacemakers or cochlear implants, postoperative artificial valve replacement, presence of ferromagnetic vascular clips in the body, metal foreign bodies in the eyeball, insulin pumps, ferromagnetic objects in the scanning field, metal dentures, intrauterine devices, and patients with claustrophobia.
研究组 & 干预措施
Clinical study on the treatment of MAFLD with palcebo capsules
干预措施: placebo capsule (Drug)
Clinical study on the treatment of MAFLD with Ganzhixiao capsules
干预措施: ganzhixiao capsule (Drug)
结局指标
主要结局
MRI-PDFF
时间窗: 16 weeks
MRI PDFF (Magnetic Resonance Proton Density Fat Fraction) is a non-invasive magnetic resonance technique used to evaluate the fat content of the liver. It reflects the concentration of free TG in tissues by measuring the ratio of the proton density of free TG to the total proton density of free TG and water, expressed as a percentage (%).
次要结局
- LSM(16 weeks)
- Pittsburgh sleep quality index(16 weeks)
- Damp Heat Traditional Chinese Medicine Syndrome Scale(16 weeks)
- ALT(16 weeks)
- CK18(16 weeks)
- FIB-4(16 weeks)
- body weight(16 weeks)
- waist circumference(16 weeks)
- hip circumference(16 weeks)
- waist to hip ratio(16 weeks)
- Waist hip height ratio(16 weeks)
- Self-Rating Anxiety Scale(16 weeks)
- Self-rating depression scale(16 weeks)
研究者
Dong Hui
Professor
Tongji Hospital