Comparison of Buyang Huanwu Granules and Naoxintong Capsules in Treatment of Stable Angina Pectoris: Rationale and Design of a Randomized, Double-blind, Multicenter Clinical Trial

Abstract

Background: Stable angina pectoris (SAP) is seriously threatened the health of human life currently, and the mortality is in a continuous rising stage. The current treatment strategies mainly include pharmaceutical therapy and revascularization. In China, Buyang Huanwu granules (BYHW) and Naoxintong capsule (NXT) have been used in the treatment of SAP, but it is not clear which one is better in terms of relieving symptoms and improving quality of life. Therefore, we design a clinical trial to compare the efficacy and safety between NXT and BYHW in the treatment of SAP. Methods: This is a randomized, double-blinded, parallel controlled, multicenter clinical trial protocol. On the basis of western medicine standardized treatment, a total of 128 SAP patients will be randomly divided into intervention group 1 (NXT group), intervention group 2 (BYHW group) and control group (placebo group) at a 2:1:1 ratio. A 2-week run-in period is required prior to randomization, and 1-week baseline period and 4-week treatment period are included in this study. The primary outcome is the efficacy rate of stable angina symptom score improvement; the secondary outcomes include the effect of electrocardiogram, Seattle Angina Questionnaire scores, and the nitroglycerin consumption. Discussion: This study will evaluate the efficacy and safety between NXT and BYHW in the treatment of SAP. The results will provide critical evidence of the Chinese herbal medicine for SAP. Trial registration: Chinese Clinical Trials Registry ChiCTR1800015191. Registered on 13 March 2018. http://www.chictr.org.cn/showproj.aspx?proj=25818