Primary Biliary Cholangitis
Conditions
Interventions
study group:Ursodeoxycholic acid + Jiawei Yinchenhao Decoction
control group:Ursodeoxycholic acid + Placebo
Sponsors
Gongli Hospital of Shanghai Pudong New Area
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.both meet the criteria for the diagnosis of Primary Biliary Cholangitis and the criteria of dampness and heat stasis of TCM; 2. Age 18 to 80 years; 3. Sign informed consent.
Exclusion criteria
Exclusion criteria: 1. serum alanine aminotransferase (ALT) or aminotransferase (AST) > 5× ULN; total bilirubin (TB) > 2× ULN; and serum creatinine (Scr) > 2× ULN; 2. Methotrexate, azathioprine, or glucocorticoids in the first 3 months of enrollment; 3. Patients who are pregnant or who are planning to be pregnant or breastfeeding; 4. allergic to Jiawei Yinchenhao Decoction or/and UDCA; 5. Combined autoimmune hepatitis, viral hepatitis, liver tumor or drug-induced liver disease. 6. Combined hepatic coma, gastrointestinal haemorrhage, shock, and severe cardiopulmonary disease; 7. Combined severe mental illness, history of alcohol abuse, drug or other substance abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver function; | — |
Secondary
| Measure | Time frame |
|---|---|
| B-ultrasonography or liver MRI;PBC-40 Questionnaire;VAS score for pruritus; | — |
Countries
China
Contacts
Public ContactYiyun Chen
Gongli Hospital of Shanghai Pudong New Area
Outcome results
None listed