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
- Conditions
- primary biliary cholangitis
- Registration Number
- ITMCTR2000003795
- Lead Sponsor
- Shanghai chinese medicine hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
(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.
(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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Gamma-glutamyl transpeptidase;alkaline phosphatase;gut microbiota;
- Secondary Outcome Measures
Name Time Method