Shenzhu Guanxin Recipe Granules () for Improving Exercise Tolerance in Patients with Stable Angina (SERIES Trial): A Protocol of Multicenter, Randomized, Double-Blind, Placebo Parallel Controlled Clinical Trial.
10.1007/s11655-018-3017-z
- Author:
Shuai MAO
1
;
Dan-Ping XU
1
;
Xiao-Jing DANG
1
;
Winny LI
2
;
Huan-Lin WU
3
Author Information
1. Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China.
2. Faculty of Medicine, University of Toronto, Toronto, M5G 0A4, Canada.
3. Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China. drhuanlinwu@aliyun.com.
- Publication Type:Journal Article
- Keywords:
Shenzhu Guanxin Recipe;
coronary microcirculation;
exercise tolerance;
randomized controlled trial;
stable angina;
trial protocol
- MeSH:
Angina, Stable;
drug therapy;
physiopathology;
Coronary Circulation;
Double-Blind Method;
Drugs, Chinese Herbal;
adverse effects;
therapeutic use;
Exercise Test;
Exercise Tolerance;
physiology;
Humans;
Placebos;
Sample Size
- From:
Chinese journal of integrative medicine
2019;25(2):96-102
- CountryChina
- Language:English
-
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 (, 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).
