Huatan Dingji Decoction Intervening in Atrial Fibrillation : Protocol for a Randomized Double-Blind Single-Simulated Placebo-Controlled Clinical Trial

Abstract

\n Background: Atrial fibrillation (AF) is one of the most common cardiac arrhythmias and can lead to heart failure(HF), stroke, pulmonary embolism(PE) and other complications, seriously affecting people s quality of life and health.Western medicine is limited in the treatment of AF, while Traditional Chinese Medicine(TCM) has unique advantages, such as low side effects, low toxicity, long effect duration and high compliance.Huatan Dingji Decoction(HTDJ) is commonly used in the treatment of AF in our hospital, and its clinical efficacy is confirmed, but a comprehensive evaluation of the clinical efficacy is currently lacking. Method: This study adopts a randomized double-blind, single-simulated, placebo-controlled research method. Participants were randomly assigned in a 1:1 ratio through a centrally controlled, computer-generated, simple randomization schedule. Participants would take the medicine for one month and the curative effect would be evaluated. Subsequently, the participants would not take TCM and only receive western medicine treatment. They would be followed up for another 8 weeks, and a clinical evaluation would be conducted.The evaluation includes the frequency of palpitation, cumulative attack time, increase and decrease rate of western medicine, TCM symptoms, clinical quality of life, clinical endpoint events and safety. Cases are derived from outpatient and inpatient with AF in the Cardiology Department of Longhua Hospital. Evaluations would be conducted at baseline and at week 4 and 12 after randomization.Discussion:In this study, the efficacy and safety of HTDJ plus western medicine in the treatment of AF(palpitation of Qi deficiency-caused phlegm stagnation) were evaluated, so as to provide medicine evidence of short-term and medium-term clinical efficacy for the treatment of AF with integrated traditional and western medicine, and lay a foundation for further clinical development and application.Trial registration: The trial has been registered on March 5,2020 at Chinese Clinical Trial Registry (www.chictr.org.cn; ID:ChiCTR2000030517).Trial registration: This study was registered on May 15,2019 at ClinicalTrials.gov with the identifier number NCT03952676.