Effectiveness and safety of Chinese herbal medicines for hepatitis B virus-related acute-on-chronic liver failure:study protocol for a multicenter randomized controlled trial
Effectiveness and safety of Chinese herbal medicines for hepatitis B virus-related acute-on-chronic liver failure: study protocol for a multicenter randomized controlled trial作者机构:Integrated Traditional Chinese Medicine&Western Medicine Departmentthe Fifth Medical CenterGeneral Hospital of PLABeijing 100039China
出 版 物:《Journal of Traditional Chinese Medicine》 (中医杂志(英文版))
年 卷 期:2020年第40卷第6期
页 面:1052-1059页
核心收录:
学科分类:1007[医学-药学(可授医学、理学学位)] 100506[医学-中医内科学] 1006[医学-中西医结合] 1005[医学-中医学] 1002[医学-临床医学] 10[医学] 100602[医学-中西医结合临床]
主 题:Acute-on-chronic liver failure Hepatitis B chronic Drugs Chinese herbal Randomized controlled trial Clinical protocols
摘 要:OBJECTIVE:To conduct a multicenter randomized controlled trial of the efficacy of standardized Chinese herbal medicines(CHMs)against acuteon-chronic liver failure(ACLF)and provide reproducible and high-level evidence for clinical ***:This is a prospective,multicenter,centrally randomized controlled *** diagnosed with hepatitis B virus-related ACLF(n=510)will be allocated to the standard medical therapy or CHM group at a 1∶1 *** CHMs will be used on the basis of the traditional Chinese medicine syndrome:Liangxue Jiedu granules for excess syndromes and Yiqi Jiedu granules for deficiency *** primary outcome is transplant-free survival at week *** secondary outcomes are(a)transplant-free survival at week 24,(b)liver function as assessed using the model for end-stage liver disease score at week 12,(c)liver function as assessed using the Child-Pugh score at week 12,and(d)the incidence of complications at week ***:The effectiveness and safety of CHM formulations will be assessed following treatment for *** REGISTRATION:The trial was registered at Clinical ***(NCT03577938)on June 24,2018.