Efficacy and safety of Naoxintong capsule for treating chronic stable angina: study protocol for a randomized controlled trial

Abstract Background Cardiovascular disease is the leading cause of mortality and morbidity worldwide, Chronic stable angina (CSA) main symptom myocardial ischemia, causes increased risk major cardiovascular events such as sudden cardiac death infarction. Naoxintong (NXT) capsule a classical traditional Chinese medication used to treat CSA, however, few evidence support wide utility NXT for treatment CSA. We design this study evaluate efficacy safety versus placebo in patients with Methods/design This multicenter, randomized, double-blind, placebo-controlled clinical trial. A total 260 eligible participants will be enrolled. The randomized assigned an equal ratio groups receiving either or 12 weeks. After 2-week run-in period, they receive (3 pills, 3 times daily) primary outcome therapeutic efficacy. Secondary measures include quantitative score TCM syndromes, severity grading pectoris, number pectoris per week, nitroglycerin dosage, Seattle scale, serum homocysteine, incidence events. Safety outcomes adverse monitored throughout Discussion designed accordance principles regulations issued by China Food Drug Administration (CFDA). results provide Capsule Trial registration Clinical Registry ChiCTR2100044563 . Registered on 24 March 2020.