研究疾病:
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非酒精性脂肪性肝炎
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研究疾病代码:
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Target disease:
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non-alcoholic steatohepatitis
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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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病例对照研究
Case-Control study
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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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运用多中心、随机、双盲、平行对照、第三方评价的方法,研究化痰祛湿活血方对肥胖型NASH患者的干预作用及临床疗效,为指导临床提供高级别循证证据。
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Objectives of Study:
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Using a multicenter, randomized, double-blind, parallel-controlled, third-party evaluation method, we investigated the interventional effects and clinical efficacy of the formula to remove phlegm and dampness and invigorate blood in obese NASH patients to provide high-level evidence-based evidence to guide clinical practice.
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药物成份或治疗方案详述:
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化痰祛湿活血方颗粒(组成:泽泻 30g,丹参 15g,海藻 15g,荷叶 15g,垂盆草15g,党参 10g,薏苡仁 15g,五味子 15g,桂枝 3g,柴胡 6g。):每次 1 袋,以开水 100ml 冲服,每日 2 次,(即每日 1 剂)。每周服药 6 天,休息 1 天。
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Description for medicine or protocol of treatment in detail:
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Blood circulation and blood circulation by dissolving phlegm and dispelling dampness (composition: 30g of Zedoary, 15g of Salvia, 15g of seaweed, 15g of lotus leaf, 15g of pelargonium15g, Radix Codonopsis Pilosulae 10g, Coix Coix Seed 15g, Fructus Schisandrae 15g, Osmanthus 3g, Radix Bupleurum 6g): 1 sachet each time, 100ml of boiled water, 2 times daily (i.e. 1 dose daily).Take 2 times a day (i.e. 1 dose per day). Take the medicine 6 days a week with 1 day of rest.
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纳入标准:
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(1)年龄:18岁~65岁,男女不限;
(2)同时符合中、西医诊断标准;
(3)1倍正常上限<血清ALT下降≤3倍正常上限,持续4周以上。
(4)空腹血糖≤7.0mmol/L;
(5)签署知情同意书;
(6)未服用治疗非酒精性脂肪性肝炎的其他药物,或在纳入观察4周前已停用其他治疗NASH的药物者。
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Inclusion criteria
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(1) Age: 18 to 65 years old, regardless of gender.
(2) Meeting both Chinese and Western medical diagnostic criteria.
(3) 1 times the upper limit of normal < serum ALT decreased ≤ 3 times the upper limit of normal for more than 4 weeks.
(4) Fasting blood glucose ≤ 7.0 mmol/L.
(5) Signed informed consent.
(6) Not taking other drugs for the treatment of NAFLD or who have discontinued other drugs for the treatment of NASH before 4 weeks of inclusion for observation.
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排除标准:
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(1)病毒性肝炎、药物性肝病、全胃肠外营养、肝豆状核变性、自身免疫性肝病等;
(2)患严重心、脑、肾、造血系统疾病和焦虑、抑郁等情绪性疾病及精神病者;
(3)长期使用糖皮质激素、氯丙嗪、胰岛素等引起的脂肪肝;
(4)Ⅰ型糖尿病患者;
(5)各类恶性肿瘤患者或既往有恶性肿瘤病史者;
(6)孕妇和哺乳期妇女;
(7)正在参加其它临床试验者;
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Exclusion criteria:
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(1) viral hepatitis, drug-related liver disease, total parenteral nutrition, hepatomegaly, autoimmune liver disease, etc.
(2) Those suffering from serious heart, brain, kidney, hematopoietic system diseases and emotional diseases such as anxiety, depression and psychiatric disorders.
(3) Fatty liver caused by long-term use of glucocorticoids, chlorpromazine, insulin, etc.
(4) Patients with type I diabetes mellitus.
(5) Patients with various types of malignant tumors or those with previous history of malignant tumors
(6) Pregnant and lactating women.
(7) Those who are participating in other clinical trials.
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研究实施时间:
Study execute time:
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从From
2022-01-01
至To
2024-12-31
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征募观察对象时间:
Recruiting time:
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从From
2022-06-01
至To
2024-05-31
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