Efficacy and safety of umbilical therapy with the traditional Chinese medicine formulation Lishui Xiaogu cataplasm for cirrhotic ascites: protocol for a randomized controlled trial.

BACKGROUND: 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.

DISCUSSION: 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.

TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR-INR-16007686 . Registered on 1 January 2016.