Fuzhenghuayu in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Ursodeoxycholic acid (UDCA) has been the only treatment for PBC approved by US and European
drug administrations. Long-term use of UDCA (13-15 mg/kg/day) in patients with PBC improves
serum liver biochemistries and survival free of liver transplantation.
However, about 40% of patients do not respond to UDCA optimally as assessed by known criteria
for biochemical response. Those patients represent the group in need for additional
therapies, having increased risk of disease progression and decreased survival free of liver
transplantation. And UDCA has less effect on PBC patients whose pathology stage 3-4. Liver
fibrosis might jeopardize the UDCA effect. Fuzhenghuayu is a Chinese traditional medicine for
liver fibrosis and cirrhosis. Both lab research and some clinical studies suggest that
Fuzhenghuayu could significantly reverse liver fibrosis and cirrhosis due to different kind
of etiology. Here the investigators start a random, open and parallel clinical research to
explore the effect of Fuzhenghuayu combined with UDCA in the PBC treatment.