NCT03577938|CompletedDMC
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Sponsor study identifier
interventional
516
1 country
15
Study Start
January 10, 2019
Actual (reported)Primary Completion
June 30, 2021
Actual (reported)Study Completion
June 30, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2021
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 5, 2018
Actual (reported)July 5, 2018
Actual (reported)January 10, 2019
Actual (reported)June 30, 2021
Actual (reported)June 30, 2021
Actual (reported)transplant free survival
transplant free survival at the time point of week 12
week 12
transplant free survival
week 24
liver function assessed by MELD score
week 12
liver function assessed by Child-Pugh score
week 12
Quality of life assessed by WHOQOL-BRIEF
week 12
incidence of complications
from week 1 to week 12
One dosage of Chinese herbal medicine by oral administration per day for 8 weeks. For patients who cannot take oral medicine can be switched to colon route by the colonic therapy system（IMS-100A produced by Sunny Medical in Beijing China).
Patients in the control group only receive the standard medical treatment (SMT), no control drug with CHM.
One dosage of CHM includes Artemisiacapillaris Thunb (30g), Salvia miltiorrhiza Bge (30g), Rhizoma Atractylodis Macroce- phalae (30g), Rubia cordifolia L (30g), Sieyesbeckiaorientalis L (30g). Paeoniae Radix Rubra (60g), Gardenia jasminoides Ellis (9g), Hedyotis diffusa Willd (30g) and Bletilla striata (15g) are involved for excess syndrome, and Astragalus membranaceus (30g), Radix Pseudostellariae (15g), Radix Aconiti Lateralis Praeparata (10g), Galli Gigeriae Endothelium Corneum (20g), Polygonum cuspidatum Sieb.et Zucc (15g) are involved for deficiency syndrome.
302 military hospital of China
Beijing, Beijing Municipality, China
Beijing Ditan hospital
Beijing, Beijing Municipality, China
Beijing youan hospital
Beijing, Beijing Municipality, China
Fuzhou infectious hospital
Fuzhou, Fujian, 350025, China
Xiamen hospital of traditional Chinese medicine
Xiamen, Fujian, China
Hubei hospital of traditional Chinese medicine
Wuhan, Hubei, China
Tongji hospital, Huazhong university of science and technology
Wuhan, Hubei, China
Man Gong, Doctor
Beijing 302 Hospital
Kewei Sun
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Zhengfang Liu
Fuzhou Infectious Hospital
Jiefei Wang
Shanghai Public Health Clinical Center
516 participants (actual enrollment reported by the registry).
First Submitted
June 5, 2018
First Posted
July 5, 2018
Study Start
January 10, 2019
Actual (reported)Efficacy of Addition of Fecal Microbiota Transplant (FMT) and Plasma Exchange to Tenofovir in Comparison to Monotherapy With Tenofovir in ACLF-HBV
SMT therapy includes a high-calorie diet; nucleoside analogues for HBV DNA-positive patients; sodium restriction, diuretics and paracentesis combined with albumin infusion for ascites; lactulose and L-ornithine aspartate and lactulose for HE and hyper-ammonia; hemostatic treatment for gastrointestinal hemorrhage; antibiotics for infections and renal replacement for HRS and uremic symptoms.
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The first affiliated hospital of Hunan university of traditional Chinese medicine
Changsha, Hunan, 410000, China
Jilin hepatology hospital
Changchun, Jilin, China
The sixth people's hospital of Shenyang
Shenyang, Liaoning, China
Shanghai public health clinical center
Shanghai, Shanghai Municipality, China
Shuguang hospital, Shanghai university of traditional Chinese medicine
Shanghai, Shanghai Municipality, China
Chengdu public health clinical center
Chengdu, Sichuan, China
The second people's hospital of Tianjin
Tianjin, Tianjin Municipality, China
Hangzhou Xixi hospital
Hangzhou, Zhejiang, China
Yunhui Zhuo
Shuguang Hospital of Shanghai University of Traditional Chinese Medicine
Shuqin Zhang
Jilin hematology hospital
Wukui Cao
Tianjin Second People's Hospital
Zhengang Zhang
Tongji Hospital
Lin Wang
Chengdu Public Health Clinical Center
Ye Gu
Shenyang Sixth People's Hospital
Jianchun Guo
Hangzhou Xixi hospital
Xianbo Wang
Beijing Ditan Hospital
Xiuhui Li
Beijing YouAn Hospital
Xiaozhou Zhou
Affiliated Hospital of Nanjing University of Chinese Medicine
Jinmo Tang
Xiamen Hospital of Traditional Chinese Medicine
Hanmin Li
Hubei traditional Chinese medicine hospital
Primary Completion
June 30, 2021
Actual (reported)Study Completion
June 30, 2021
Actual (reported)Last Updated
March 31, 2022
Record last verified: 2022-03
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