Primary Biliary Cholangitis
Conditions
Interventions
control group:Placebo
Sponsors
Shuguang Hospital affiliated to Shanghai University of TCM
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Ages 18-65 years, regardless of gender; 2. Meet the diagnostic criteria of primary bile cholangitis, that means, after excluding viral hepatitis, the patient must meet at least two of the following three criteria: (1) serum alkaline phosphatase (ALP) is elevated; (2) Anti-mitochondrial antibody (AMA) and / or AMA-M2 is positive; (3) liver biopsy: histological evidence of non-purulent destructive cholangitis and interlobular bile duct destruction 3. Comply with the moderate to severe assessment standards in the fatigue self-assessment scale; 4. Course of disease >= 1 year; 5. The subject or his guardian agrees enrolment in the randomized controlled trials and signs the informed consent.
Exclusion criteria
Exclusion criteria: 1. Other conditions that the researcher consider not suitable for enrollment. 2. With liver disease caused by alcohol, drugs or other reasons; 3. Liver imaging suggests a large bile duct obstruction; 4. Patients with severe heart, lung, kidney and other organ diseases; 5. Incomplete information, which affects effectiveness and safety judgment; 6. Patients with combined autoimmune hepatitis; 7. Poor compliance; 8. Pregnant and lactating women; 9. Patients with end-stage complications such as infection and massive refractory ascites; 10. Patients who are allergic to Astragalus, Licorice and ursodeoxycholic acid.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| liver function; | — |
Secondary
| Measure | Time frame |
|---|---|
| kidney function;blood test;urine test;Coagulation function;Ultrasound;Fibroscan; | — |
Countries
China
Contacts
Public ContactShili Jiang
Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed