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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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机构: [1]Second Clinical Medical College, Guangzhou University ofChinese Medicine, Guangzhou (510405), China [2]Heart Center,Guangdong Provincial Hospital of Chinese Medicine, Guangzhou(510120), China [3]Faculty of Medicine, University of Toronto,Toronto M5G 0A4, Canada [4]Beijing University of ChineseMedicine, Beijing (100029), China
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关键词: exercise tolerance stable angina Shenzhu Guanxin Recipe coronary microcirculation trial protocol randomized controlled trial

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BackgroundMany patients with chronic angina experience anginal episodes despite successful recanalization, antianginal and antiischemic medications. Empirical observations suggested that Shenzhu Guanxin Recipe Granules (???????, 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.MethodsA 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.DiscussionThis 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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基金编号: 2012A032500017 YN2014LN07 YK2013B1N10 A2016192 2015A030310437 2015A030306049 81403341 81703877

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出版当年[2018]版:
大类 | 4 区 医学
小类 | 4 区 全科医学与补充医学
最新[2025]版:
大类 | 4 区 医学
小类 | 4 区 全科医学与补充医学
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出版当年[2017]版:
Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE
最新[2023]版:
Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

影响因子: 最新[2023版] 最新五年平均 出版当年[2017版] 出版当年五年平均 出版前一年[2016版] 出版后一年[2018版]

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第一作者机构: [1]Second Clinical Medical College, Guangzhou University ofChinese Medicine, Guangzhou (510405), China [2]Heart Center,Guangdong Provincial Hospital of Chinese Medicine, Guangzhou(510120), China
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通讯机构: [1]Second Clinical Medical College, Guangzhou University ofChinese Medicine, Guangzhou (510405), China [2]Heart Center,Guangdong Provincial Hospital of Chinese Medicine, Guangzhou(510120), China [4]Beijing University of ChineseMedicine, Beijing (100029), China
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