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临床试验/ITMCTR2000003508
ITMCTR2000003508尚未招募1 期

Clinical evaluation of Yinchenhao decoction in the treatment of Nonalcoholic Fatty Liver Disease (hepatobiliary dampness-heat syndrome)

Shuguang Hospital affiliated with Shanghai University of TCM0 个研究点开始时间: 待定最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional study

入排标准

年龄范围
18 至 60(—)
性别
All

入选标准

  • Referring to the diagnostic criteria of NAFLD in the guidelines for the prevention and treatment of non-alcoholic fatty liver disease (2018 update), the diagnostic criteria of hepatobiliary dampness-heat syndrome established by the consensus opinion on the diagnosis and treatment of non-alcoholic fatty liver disease by integrated traditional Chinese and western medicine (2017) are as follows:
  • 1. Between the ages of 18 years and 60 years (including), there is no limit on sex;
  • 2. Patients who meet the diagnostic criteria of NAFLD,Liver imaging findings meet the diagnostic criteria of diffused fatty liver, and there is no other reason to explain and / or have metabolic syndrome related components in patients with unknown causes of serum ALT, / or AST, GGT continued to increase for more than half a year.
  • 3. Meet the diagnostic criteria of liver and gallbladder dampness-heat syndrome of traditional Chinese medicine.
  • 4. MRI PDFF mean >= 8%, Willing to accept regular physical and chemical examinations related to fatty liver;
  • 5. I or my guardian agree to participate in the clinical trial control study and sign the informed consent form.

排除标准

  • 1. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) > 5*ULN, total bilirubin (TBIL) > 2*ULN;
  • 2. Alcoholic fatty liver (male alcohol intake > 210g/week, female alcohol intake > 140g/week);
  • 3. Combined with viral, autoimmune and other liver diseases, or taking drugs that may cause fatty liver;
  • 4. Combined with diabetes (glycated hemoglobin >= 6.5%, or fasting blood glucose >= 7.0mol/L, or 2 hours postprandial blood glucose >= 11.1mmol/L), malignant tumors, connective tissue diseases and severe heart, liver, hematopoietic, and nervous system complications , Or clearly have other important diseases;
  • 5. Pregnant or breastfeeding women, allergic physique, allergic to drugs, and patients with mental illness;
  • 6. Patients who have undergone gastrointestinal bariatric surgery within the past year or who have taken weight-loss drugs within the past three months have lost >10%.

研究者

发起方
Shuguang Hospital affiliated with Shanghai University of TCM

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