Clinical Evaluation and Study of Huangqi Decoction in Treating Severe Fatigue in Primary Biliary Cholangitis
- Conditions
- Primary Biliary Cholangitis
- Registration Number
- ITMCTR2000003160
- Lead Sponsor
- Shuguang Hospital affiliated to Shanghai University of TCM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
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.
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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method liver function;
- Secondary Outcome Measures
Name Time Method Coagulation function;Ultrasound;blood test;kidney function;urine test;Fibroscan;