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Shenzhu Guanxin Recipe Granules (参术冠心方颗粒) for Improving Exercise Tolerance in Patients with Stable Angina (SERIES Trial): A Protocol of Multicenter, Randomized, Double-Blind, Placebo Parallel Controlled Clinical Trial

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Abstract

Background

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

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

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)

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Acknowledgement

The authors gratefully acknowledge the contributions of all the investigators, and participants of the trial.

Author information

Authors and Affiliations

  1. Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China

    Shuai Mao, Dan-ping Xu, Xiao-jing Dang & Huan-lin Wu

  2. Heart Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China

    Shuai Mao, Dan-ping Xu, Xiao-jing Dang & Huan-lin Wu

  3. Faculty of Medicine, University of Toronto, Toronto, M5G 0A4, Canada

    Winny Li

  4. Beijing University of Chinese Medicine, Beijing, 100029, China

    Huan-lin Wu

Authors
  1. Shuai Mao
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  2. Dan-ping Xu
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Corresponding author

Correspondence to Huan-lin Wu.

Additional information

Supported by Foundation from Department of Science and Technology of Guangdong Province (No. 2012A032500017), Foundation from Guangdong Provincial Academy of Traditional Chinese Medicine (No. YN2014LN07, YK2013B1N10, A2016192), Science Foundation of Guangdong Province (No. 2015A030310437, 2015A030306049), and National Natural Science Foundation (No. 81403341, 81703877)

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Mao, S., Xu, Dp., Dang, Xj. et al. Shenzhu Guanxin Recipe Granules (参术冠心方颗粒) for Improving Exercise Tolerance in Patients with Stable Angina (SERIES Trial): A Protocol of Multicenter, Randomized, Double-Blind, Placebo Parallel Controlled Clinical Trial. Chin. J. Integr. Med. 25, 96–102 (2019). https://doi.org/10.1007/s11655-018-3017-z

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