Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06371196
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-03-13
Brief Title:
Clinical Study on the Treatment of Elevated Total Bilirubin in Primary Biliary Cholangitis With Baobao Dan Capsule
Sponsor:
Mei Han
Organization:
Beijing University of Chinese Medicine
Study Overview
Official Title:
Clinical Study on the Treatment of Elevated Total Bilirubin in Primary Biliary Cholangitis With Baobao Dan Capsule
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
2 To observe the positive intervention effect of Babaodan Capsule on the clinical symptoms of primary biliary cholangitis patients with elevated total bilirubin
Detailed 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 AMAAMA-M2 and anti-gp210 antibody anti-sp100 antibody 6 Adverse events and safety evaluation
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 AMAAMA-M2 and anti-gp210 antibody anti-sp100 antibody 6 Adverse events and safety evaluation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None