NCT06188611已完成4 期
A Placebo Control, Randomized, Double-blind, Multicenter Phase IV Study to Investigate the Efficacy and Safety of Huazhi Rougan Granule in the Treatment of Non-alcoholic Simple Fatty Liver (Damp-heat Obstruction Syndrome: Shi-Re-Zhong-Zu Zheng)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 282
- 试验地点
- 1
- 主要终点
- Liver-to-spleen CT ratio
研究概览
简要总结
A Placebo control, Randomized, Double-blind, Multicenter Phase IV study to investigate the efficacy and safety of Huazhi Rougan granule in the treatment of non-alcoholic simple fatty liver (damp-heat obstruction syndrome: Shi-Re-Zhong-Zu Zheng)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 and≤65 years old;
- •Those who meet the diagnostic criteria of non-alcoholic simple fatty liver and traditional chinese medicine syndrome classification of damp-heat obstruction syndrome;
- •Liver-to-spleen CT ratio ≤ 0.8; The imaging findings of liver were consistent with the diagnostic criteria of diffuse fatty liver; ④ Voluntarily sign informed consent. The legal representative can sign informed consent on behalf of the patient who are unable to sign； ⑤ FPG≤7.0mmol/L 、HbA1c≤6.5%；ALT、AST、TBil≤2×ULN.
排除标准
- •Fatty liver caused by chronic heart failure, malnutrition and pregnancy, encephalopathy fatty liver syndrome (Reye syndrome), B-lipoprotein deficiency, localized fatty liver; Fatty liver caused by diabetes, long-term use of hormones, enteritis, gastrointestinal postoperative chronic infection, etc.; Small intestinal bypass surgery, hepatocyte toxicity injury, chronic febrile diseases such as tuberculosis, ulcerative nodules;；
- •Severe fatty liver with ascites, edema, hyponatremia, hypokalemia and other suspected cirrhosis; Hepatitis or cirrhosis caused by viruses, drug poisoning, immune diseases and other factors;；
- •Those who had used any Chinese or Western drugs for the treatment of simple fatty liver within one month before randomization；
- •Pregnant or lactating women, women of childbearing age who do not take effective contraceptive measures (such as condoms, hormonal contraceptives, intrauterine devices) or male subjects who do not want to use contraception;；
- •Patients with serious primary cardiovascular diseases, liver diseases, kidney diseases, hematological diseases, lung diseases, tumors, AIDS and other serious diseases that affect survival. For example: abnormal kidney function: creatinine higher than the upper limit of normal; Abnormal liver function: γ-GT>200U/L or ALT >2×ULN or AST>2×ULN; A clinically significant arrhythmia；
- •⑥ According to the 2010 guidelines for the prevention and treatment of dyslipidemia, patients with dyslipidemia requiring lipid-lowering drugs intervention：TC≥6.99mmol/L（270mg/dl）or LDL-C≥4.92mmol/L（190mg/dl）；
- •⑦ Persons without or with limited capacity for civil conduct；
- •⑧ Those who has suspected or confirmed history of alcohol abuse (alcohol equivalent male≥40g/d, female ≥20g/d) or drug abuse；
- •⑨ Allergic to the components of this drug；
- •⑩ Those who participated in other clinical investigators within 3 months prior to screening；
- •⑪ The investigators consider she/he inappropriate to participate in this study。
研究组 & 干预措施
Huazhi Rougan granule
Experimental
Take with boiling water ,3 times a day, for 24 weeks;
干预措施: Huazhi Rougan Granule Placebo granule (Drug)
Placebo granule
Placebo Comparator
Take with boiling water ,3 times a day, for 24 weeks;
干预措施: Huazhi Rougan Granule Placebo granule (Drug)
结局指标
主要结局
Liver-to-spleen CT ratio
时间窗: week 24
次要结局
- AE、SAE(week 24)
- Laboratory test index:Traditional Chinese medicine (TCM) syndrome points(week 24)
- TG、ALT、AST、γ-GT、TBIL、HOMA-IR(week 24)
研究者
研究点 (1)
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