Safety and efficacy of Qishen granules in patients with chronic heart failure: study protocol for a randomized controlled trial

This study is designed as a randomized, placebo-controlled, multi-center, double-blind clinical trial with parallel groups. A total of 200 patients with CHF will be recruited and randomly allocated to either the QSG treatment group or the placebo group (in a 1:1 ratio). The patients will receive QSG or placebo granules twice a day for 12  weeks. The primary outcome is the proportion of patients in the QSG group, compared with the placebo group, demonstrating a more than 30% decrease in NT-proBNP level during 12 weeks of treatment. The secondary outcomes consist of composite cardiac events, New York Heart Association functional cla ssification, 6-minute walking distance, left ventricular ejection fraction, patient quality of life, and the TCM syndrome integral scale.DiscussionOn a background of standard treatment, QSG may further reduce the levels of NT-proBNP. This trial will provide high-quality evidence on the efficacy and safety of QSG in treating CHF, thus providing reference for clinical application of QSG.Trial registrationClinical Trials.gov:NCT03027375. Registered on 16 January 2017.
Source: Trials - Category: Research Source Type: clinical trials