Background:

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Many patients with chronic angina experience anginal episodes despite successful recanalization

antianginal and antiischemic medications. Empirical observations suggested that Shenzhu Guanxin Recipe Granules (参术冠心方颗粒

SGR)

a Chinese herbal compound

exerted potential impacts on increased treadmill exercise performance and angina relieve. However

there has been no systematic study to clarify the impact of SGR on exercise tolerance in patients with stable angina. The SERIES (ShEnzhu guanxin Recipe for Improving Exercise tolerance in patients with Stable angina) trial is designed to determine the effects of SGR on exercise duration

electrocardiographic (ECG) evidence of myocardial ischemia

and incidence of major adverse cardiac events (MACE) in stable anginal patients.

Methods:

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A total of 184 eligible patients with stable angina will be randomly assigned to receive placebo or SGR (10 g/day for 12 weeks) in a 1:1 ratio. The primary outcome will be the change from baseline in total exercise tolerance duration

time to onset of angina and ECG ischemia during exercise treadmill testing performed over a 12-week study period. The secondary outcome will include ECG measures

the occurrence and composite of MACE and the Seattle Angina Questionnaire score. Moreover

the coronary microcirculation will be evaluated to explore the possible effects in response to treatment of SGR. After the procedure

all participants will be followed up by interview at 3 and 6 months

enquiring about any cardiac events

hospitalizations

cardiac functional level and medication usage. Additionally

the occurrence of adverse events will be evaluated at each follow-up.

Discussion:

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This study may provide novel evidence on the efficacy of SGR in improving exercise tolerance and potentially reducing clinical adverse events. (Trial registration No. ChiCTR-TRC-14004504)