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Clinical Study on the Treatment of Elevated Total Bilirubin in Primary Biliary Cholangitis With Baobao Dan Capsule

Primary Biliary Cholangitis Clinical Trial

Official title:
Clinical Study on the Treatment of Elevated Total Bilirubin in Primary Biliary Cholangitis With Baobao Dan Capsule

Clinical Trial Summary

1. Explore the effect of Babaodan Capsule on the serum total bilirubin level of primary biliary cholangitis patients with elevated total serum bilirubin; 2. To observe the positive intervention effect of Babaodan Capsule on the clinical symptoms of primary biliary cholangitis patients with elevated total bilirubin.

Clinical Trial Description

1. Primary objective: to investigate the effect of Baobao Dan capsule on serum total bilirubin levels in patients with primary biliary cholangitis with elevated total serum bilirubin. 2. Secondary objective: to observe the effects of Babaodan Capsule on the following aspects in patients with primary biliary cholangitis with elevated total bilirubin: (1) Other indicators of liver function: ALP, GGT, AST, ALT, TBA, TBil, DBil, IBil; (2) Itching and fatigue symptom scores; (3) Biochemical response rate; (4) Histologic changes; (5) Changes in immunologic indices (serum IgM, IgG, IgA, autoantibodies AMA/AMA-M2 and anti-gp210 antibody, anti-sp100 antibody); (6) Adverse events and safety evaluation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06371196
Study type Interventional
Source Beijing University of Chinese Medicine
Contact Lin Shuiping
Phone 136660698451
Email linsp@dinglu.com.cn
Status Not yet recruiting
Phase Phase 4
Start date April 25, 2024
Completion date December 31, 2025
View Details
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