Comparison of Buyang Huanwu granules and Naoxintong capsules in the treatment of stable angina pectoris: rationale and design of a randomized, blinded, multicentre clinical trial

BACKGROUND: Stable angina pectoris (SAP) currently seriously threatens the health of humans, and mortality is continuously rising. Current treatment strategies mainly include pharmaceutical therapy and revascularization. In China, Buyang Huanwu granules (BYHW) and Naoxintong capsules (NXT) have been used in the treatment of SAP, but it is not clear which agent is better in terms of relieving symptoms and improving quality of life. Therefore, we designed a clinical trial to compare the efficacy and safety of NXT and BYHW in the treatment of SAP. METHODS: This is a randomized, blinded, parallel controlled, multicentre clinical trial protocol. On the basis of standardized Western medicine treatment, a total of 128 SAP patients will be randomly divided into intervention group 1 (NXT group), intervention group 2 (BYHW group), and a control group (placebo group) at a 2:1:1 ratio. A 2-week run-in period is required prior to randomization, and a 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 on electrocardiograms, Seattle Angina Questionnaire scores, and nitroglycerine consumption. DISCUSSION: This study will evaluate the efficacy and safety of NXT and BYHW in the treatment of SAP. The results will provide critical evidence for using Chinese herbal medicines to treat SAP. TRIAL REGISTRATION: Chinese Clinical Trials Registry ChiCTR1800015191. Registered on 13 March 2018. http://www.chictr.org.cn/showproj.aspx?proj=25818. All the registration items can be found within the protocol.