Yang Xianzhao, Ru Shuying, Luo Lin, Lv Xiaoying, Bai Wenjing, Zhang Fuwen, Jiang Feng
BUCM Institute of Liver Diseases, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, No. 5, Haiyuncang, Dongcheng District, Beijing, 100700, China.
Department of Gastroenterology, Dongzhimen Hospital Eastern Affiliated to Beijing University of Chinese Medicine, Beijing, 101100, China.
Trials. 2019 Feb 13;20(1):127. doi: 10.1186/s13063-019-3221-y.
Ascites is one of the most common complications of cirrhosis. Umbilical therapy with traditional Chinese medicines has been increasingly prescribed to treat cirrhotic ascites. However, high-quality evidence from clinical trials supporting such application of traditional Chinese medicines remains limited. Therefore, we designed a clinical trial to evaluate the efficacy and safety of umbilical therapy with the Lishui Xiaogu cataplasm formulation applied to treat cirrhotic ascites.
METHODS/DESIGN: This ongoing study is a double-blind, randomized, parallel, placebo-controlled trial. A total of 82 patients will be recruited and randomly assigned to either a treatment group or a placebo group, in a 1:1 ratio. The treatment group will receive umbilical therapy with the Lishui Xiaogu cataplasm plus red light irradiation along with conventional treatment; the placebo group will receive umbilical therapy with a placebo cataplasm plus red light irradiation along with conventional treatment. Interventions for both groups will be administered once daily for up to 10 days, with a 30-day follow-up after the last treatment. The primary efficacy measurement will be ascites depth. Secondary efficacy measurements will include abdominal perimeter, weight, urine volume, the symptomatic score of traditional Chinese medicine, and the Chronic Liver Disease Questionnaire. Adverse events will also be reported.
This randomized trial will be the first rigorous study designed to evaluate the efficacy and safety of umbilical therapy with Lishui Xiaogu cataplasm applied for cirrhotic ascites.
Chinese Clinical Trial Registry, ChiCTR-INR-16007686 . Registered on 1 January 2016.
腹水是肝硬化最常见的并发症之一。中药脐疗越来越多地被用于治疗肝硬化腹水。然而，支持此类中药应用的高质量临床试验证据仍然有限。因此，我们设计了一项临床试验，以评估利水消臌贴剂脐疗治疗肝硬化腹水的疗效和安全性。
方法/设计：这项正在进行的研究是一项双盲、随机、平行、安慰剂对照试验。总共将招募82名患者，并以1:1的比例随机分配到治疗组或安慰剂组。治疗组将接受利水消臌贴剂脐疗加红光照射并联合常规治疗；安慰剂组将接受安慰剂贴剂脐疗加红光照射并联合常规治疗。两组干预措施均每天进行一次，持续10天，最后一次治疗后进行30天随访。主要疗效指标将是腹水深度。次要疗效指标将包括腹围、体重、尿量、中医症状评分和慢性肝病问卷。不良事件也将被报告。
这项随机试验将是首个旨在评估利水消臌贴剂脐疗治疗肝硬化腹水疗效和安全性的严谨研究。
中国临床试验注册中心，ChiCTR-INR-16007686。于2016年1月1日注册。
