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临床试验/ITMCTR2000003795
ITMCTR2000003795招募中1 期

The effect on clinical efficacy of primary biliary cholangitis with hepatic stagnation and spleen deficiency type and the distribution of intestinal flora through Drug Pair of Ginseng and Radix Bupleuri

Shanghai chinese medicine hospital0 个研究点开始时间: 待定最近更新:

试验速览

阶段
1 期
状态
招募中
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 70(—)
性别
All

入选标准

  • (1) Meet the above western medicine diagnostic criteria, AMA titer > 1:40; Alkaline phosphatase (ALP) > 1.5 times the upper limit of normal value or glutamyl transpeptidase b> 5 ULN lasting for 24 weeks or more.
  • (2) Patients who meet the criteria for syndrome differentiation of liver depression and spleen deficiency in Traditional Chinese medicine are between 18 and 70 years old, regardless of gender.
  • (3) Informed consent, sign informed consent and volunteer for the study.

排除标准

  • (1) Pregnant or lactating women.
  • (2) Patients with viral hepatitis or other hepatotropic virus infection, alcoholic liver disease, drug-induced liver injury, primary ssclerosis cholangitis, autoimmune hepatitis, Buga syndrome, hematopathy, Wilson's disease and other liver diseases;
  • (3) Had used methotrexate, azathioprine or glucocorticoid in the 3 months before enrollment;
  • (4) Evidence of intrahepatic or extrahepatic biliary tract obstruction;
  • (5) Patients with liver failure or hepatorenal syndrome at baseline or after liver transplantation;
  • (6) Patients with serious heart, liver, kidney or other complications or complicated with liver cancer or other malignant tumors or other serious primary diseases;
  • (7) Those who have taken antibiotics in recent 2 weeks.

研究者

发起方
Shanghai chinese medicine hospital

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