研究疾病:
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非酒精性脂肪性肝病
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研究疾病代码:
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Target disease:
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Nonalcoholic Fatty Liver Disease
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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随机平行对照
randomized controlled trial(parallel group design)
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研究所处阶段:
Study phase:
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其它
Others
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研究目的:
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观察清化痰湿法治疗非酒精性脂肪性肝病(NAFLD)的临床疗效,形成清化痰湿法治疗NAFLD的诊疗规范,为中医药防治NAFLD提供规范、有效的诊疗方案。
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Objectives of Study:
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To observe the clinical efficacy of the method of clearing phlegm and dampness in the treatment of non-alcoholic fatty liver disease, to form the standard of diagnosis and treatment of NAFLD by the method of clearing phlegm and dampness, and to provide a standardized and effective diagnosis and treatment plan for the prevention and treatment of NAFLD by traditional Chinese medicine.
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药物成份或治疗方案详述:
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中药复方清化方(荷叶 15g、黄连 6g、绞股蓝 9g、垂盆草 15g、炒白术 12g、茯苓 9g、玉米须 9g、泽兰 15 g、泽泻 9g、丹参 9g、丹皮 12g)
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Description for medicine or protocol of treatment in detail:
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Qinghua Fang (Lotus leaf 15g,Coptidis rhizoma 6g,Gynostemma pentaphyllum 9g,Sedum sarmentosum 15g,Fried Atractylodes macrocephala 12g,Poria cocos 9g,Stigma maydis 9g,Eupatorium japonicum 15g,Rhizoma alismatis 9g,Salviae miltiorrhizae 9g,Moutan cortex 12g)
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纳入标准:
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1.年龄在18~75岁的男性或女性。
2.符合非酒精性脂肪性肝病诊断标准者及《非酒精性脂肪性肝病中医诊疗专家共识意见(2017)》中医证候分型的诊断标准。
3.知情同意,患者自愿受试;获得知情同意书过程应符合GCP规定。
4.血清丙氨酸氨基转移酶(ALT)≤2倍正常值上限、总胆红素(TBIL)≤2倍正常值上限
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Inclusion criteria
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1.Age 18 to 75 years;
2.Patients who meet the above western medical diagnostic criteria and the wet turbidity internal stop certificate;
3.Patients who are willing to sign informed consent.
4.Serum alanine aminotransferase (ALT) ≤ 2 times the upper limit of normal, total bilirubin (TBIL) ≤ 2 times the upper limit of normal
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排除标准:
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1.由慢性心衰、营养不良及妊娠所致的脂肪肝、Reye综合征脂肪肝、β-脂蛋白缺乏症、局限性脂肪肝患者。由糖尿病、长期使用激素、小肠旁路手术、肝细胞中毒性损伤、慢性发热性疾病如:结核病、溃疡性结肠炎、胃肠道术后慢性感染等引起的脂肪肝患者。
2.重症脂肪肝伴有腹水、水肿、低钠低钾血症等疑似肝硬化表现者;由病毒、药物中毒、免疫性疾病等因素所致的肝炎或肝硬化。
3.本次发病后已使用其他治疗单纯性脂肪肝的中西药物。
4.具有严重的原发性心血管病变、肝脏病变、肾脏病变、血液学病变、肺脏疾病、或影响其生存的严重疾病,如肿瘤或艾滋病。
5.精神或法律上的残疾患者。
6.怀疑或确有酒精、药物滥用病史,或者根据研究者的判断、具有降低入组可能性或使入组复杂化的其他病变,如工作环境经常变动等易造成失访的情况。
7.已知对本药组成成份过敏者。
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Exclusion criteria:
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1. Patients with fatty liver, Reye syndrome fatty liver, β-lipoprotein deficiency and localized fatty liver caused by chronic heart failure, malnutrition and pregnancy. Patients with fatty liver caused by diabetes, long-term use of hormones, small intestinal bypass surgery, toxic injury to liver cells, chronic febrile diseases such as tuberculosis, ulcerative colitis, and chronic infection after gastrointestinal surgery.
2. Severe fatty liver with ascites, edema, hyponatremia, hypokalemia and other suspected manifestations of liver cirrhosis; hepatitis or cirrhosis caused by virus, drug poisoning, immune diseases and other factors.
3. Other Chinese and Western medicines for the treatment of simple fatty liver have been used after this onset.
4. Patients who have serious primary cardiovascular disease, liver disease, kidney disease, hematological disease, lung disease, or serious diseases that affect their survival, such as tumor or AIDS.
5. Mentally or legally disabled patients.
6. Suspected or indeed have a history of alcohol or drug abuse, or other diseases that reduce the possibility of enrollment or complicate enrollment according to the judgment of the investigator, such as frequent changes in the working environment, which are likely to cause loss to follow-up.
7. Those who are known to be allergic to the components of this medicine.
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研究实施时间:
Study execute time:
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从From
2020-08-01
至To
2023-08-01
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征募观察对象时间:
Recruiting time:
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从From
2022-11-22
至To
2023-01-31
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