Efficacy and safety of Zhen Wu Decoction against chronic heart failure: A protocol of randomized, double-blinded, and controlled trial

INTRODUCTION: Chronic heart failure (CHF) is the end stage of several cardiac diseases. 50% of patients with severe CHF would survive less than 1 year, which has seriously affected patients’ survival and quality of life. The current modern therapy could improve survival and quality of life. However, a larger number of patients still suffer from repeated hospitalization, unsatisfactory efficacy, and many side effects. In China, Zhen Wu Decoction (ZWD), a classic prescription recorded in Treatise on Febrile Diseases, was widely used for CHF. In this study, we try to conduct a prospective, double-blinded, randomized, controlled study to evaluate the efficacy and safety of ZWD in the treatment of CHF patients in China. METHODS: Patients will be randomly divided into treatment group and control group in 1:1 ratio. Guideline directed medical therapies and ZWD will be provided for patients in treatment group, while guideline directed medical therapies and ZWD-granules simulations for control group. Left ventricular ejection fraction, left ventricular end diastolic diameter, left ventricular end systolic diameter, b-type natriuretic peptide, NT-proBNP, peak VO2, VO2 maximum, exercise time, and walking distance will be recorded. The data will be analyzed by SPSS 22.0. CONCLUSIONS: The results will evaluate the efficacy and safety of ZWD in the treatment of CHF patients. TRIAL REGISTRATION: OSF registration number: DOI 10.17605/OSF.IO/G3QNU.