Abstract
BackgroundAscites 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/designThis 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.DiscussionThis 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.Trial registrationChinese Clinical Trial Registry, ChiCTR-INR-16007686. Registered on 1 January 2016.
Highlights
Ascites is one of the most common complications of cirrhosis
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
Umbilical therapy with Traditional Chinese medicine (TCM) formulations has a long history in China, and has been popularly used to treat various diseases, including cirrhotic ascites
Summary
Ascites is one of the most common complications of cirrhosis. Umbilical therapy with traditional Chinese medicines has been increasingly prescribed to treat cirrhotic ascites. 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. Previous studies have reported the use of umbilical therapy to treat ascites [8, 9] Our aim is to evaluate the efficacy and safety of the LSXG cataplasm umbilical therapy in patients with cirrhotic ascites, using a rigorous prospective randomized controlled clinical trial. The findings of this trial may establish the corresponding operational criteria and obtain evidence-based medical evidence, so as to provide an effective alternative measure for the treatment of cirrhosis ascites
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