Study on the Optimal Strategy for Acute-on-chronic Liver Failure With Integrative Treatment
Status:
Recruiting
Trial end date:
2021-12-30
Target enrollment:
Participant gender:
Summary
Background: Acute-on-chronic liver failure (ACLF) is a syndrome characterized by acute
deterioration in the setting of chronic liver disease associated with high short-term
mortality. Currently, there is no specific treatment for patients with ACLF. Our previous
results showed that Chinese herbal medicine (CHM) could reduce the mortality rate and the
incidence of complications of ACLF effectively. In this study, we aim to conduct the
multi-center randomized controlled trial to evaluate the effect of unified CHM formulas and
provide propagable and high-level evidence for clinical practice.
Methods/design: This is a prospective, multicenter, centrally randomized controlled trial.
Five hundred and ten patients diagnosed with HBV-related ACLF will be allocated in a 1:1
ratio to SMT group (standard medical therapy) and CHM group (CHM and SMT). The primary
outcome is the transplant-free mortality rates at week 4, 8, 12, 24 and 48. Secondary
outcomes include (1) the incidence of adverse reactions, (2) influence on liver function, (3)
the incidence of serious complications and (4) the level of inflammatory cytokines.
Discussion: The effectiveness and safety of CHM formulas are assessed in the treatment of
ACLF.
Phase:
N/A
Details
Lead Sponsor:
Beijing 302 Hospital
Collaborators:
Beijing Ditan Hospital Beijing YouAn Hospital Fuzhou Infectious Hospital Guangxi University of Chinese Medicine Hangzhou Xixi hospital Hepatology hospital of Jilin Province Huazhong University of Science and Technology Hubei Hospital of Traditional Chinese Medicine Public Health Clinical Center of Chengdu Shanghai Public Health Clinical Center Shenzhen Third People's Hospital Shenzhen traditional Chinese medical hospital ShuGuang Hospital Sun Yat-sen University The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine The second people's hospital of Tianjin The Sixth People's Hospital of Shenyang Tianjin Second People's Hospital