Clinical Evaluation and Study of Huangqi Decoction in Treating Severe Fatigue in Primary Biliary Cholangitis

Shuguang Hospital affiliated to Shanghai University of TCM0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•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.

发起方

Shuguang Hospital affiliated to Shanghai University of TCM