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- Title
Efficacy and safety of YinQiSanHuang-antiviral decoction in chronic hepatitis B: study protocol for a randomized, placebo-controlled, double-blinded trial.
- Authors
Wu, Qing-Juan; Lv, Wen-Liang; Li, Juan-Mei; Zhang, Ting-Ting; Zhou, Wen-Hui; Zhang, Qiang; Wang, Jiu-Chong; Wang, Qing-Nan; Zhang, Ruo-Xuan; Zhao, Xin; Chen, Si-Tong; Liu, Shuang; Li, Gao-Hui; Cao, Zheng-Min; Xu, Lei; Chen, Jing
- Abstract
<bold>Introduction: </bold>Chronic hepatitis B (CHB) is a global public health problem. Antiviral therapy is the primary treatment. Studies have shown that a combined therapy of traditional Chinese medicine (TCM) and conventional antiviral drugs has better efficacy than conventional antiviral for treatment of CHB. YinQiSanHuang-antiviral decoction (YQSH) is a TCM compound preparation that has shown an effect on anti-hepatitis B virus and on slowing progression of hepatitis B-related liver diseases. To evaluate the efficacy and safety of YQSH combined with entecavir and its preventive effect on hepatitis B cirrhosis, we designed this randomized, double-blind and placebo-controlled trial. The objective is that the combination of YinQiSanHuang-antiviral decoction with entecavir will reduce the annual incidence of liver fibrosis/cirrhosis to 1%.<bold>Methods: </bold>This is a multicenter, randomized, placebo-controlled, double-blinded trial involving five hospitals. A total of 802 patients are randomly allocated to two groups: the YQSH group (n = 401) or the placebo group (n = 401). The YQSH group receives YQSH with entecavir; the placebo group receives granules of placebo with entecavir. Patients receive treatment for 52 weeks and then are followed up for 52 ± 2 weeks. The primary outcome measure is the annual incidence of cirrhosis. The secondary outcome measures are hepatitis B virus DNA negative rate, hepatitis B surface antigen negative rate, hepatitis B e antigen seroconversion rate, liver function (alanine aminotransferase, aspartate aminotransferase , gamma-glutamyl transferase , alkaline phosphatase , serum albumin, and total bilirubin), spleen thickness, evaluation scores of patients' clinical symptoms, and safety assessment. Outcomes will be assessed at baseline and after treatment.<bold>Discussion: </bold>Combination therapy could become a trend for treatment of CHB, and this trial expects to provide credible clinical evidence for the future combination of TCM and conventional antiviral drugs for the treatment of CHB.<bold>Trial Registration: </bold>Chinese Clinical Trial Registry: ChiCTR1900021521. Registered on 25 February 2019.
- Subjects
ALANINE aminotransferase; ASPARTATE aminotransferase; CHRONIC hepatitis B; HEPATITIS associated antigen; CLINICAL trial registries; HEPATITIS B virus; CHINESE medicine; INTEREST rates; HERBAL medicine; CIRRHOSIS of the liver; ANTIVIRAL agents; RANDOMIZED controlled trials; BLIND experiment; DRUG administration; DRUG dosage
- Publication
Trials, 2020, Vol 21, Issue 1, p482
- ISSN
1745-6215
- Publication type
journal article
- DOI
10.1186/s13063-020-04395-y