Key result
This study protocol describes a planned randomized controlled trial to evaluate whether the Yangxinshi tablet improves exercise capacity in patients with coronary heart disease over 12 weeks.
Why the study?
Exercise intolerance is common in patients with coronary heart disease, but the effect of traditional Chinese medicine on improving exercise tolerance remains unclear.
Does the Yangxinshi tablet improve exercise capacity in patients with coronary heart disease undergoing cardiac rehabilitation?
RCT (n=90)
Double-blind
1:1
Yes
Does the Yangxinshi tablet improve exercise capacity in patients with coronary heart disease undergoing cardiac rehabilitation?
This study protocol outlines a randomized controlled trial to evaluate whether the traditional Chinese medicine Yangxinshi tablet improves exercise tolerance in patients with coronary heart disease undergoing cardiac rehabilitation.
YXS may improve exercise tolerance in CHD; extends RCT evidence for TCM adjunctive use in stable patients.
BACKGROUND: Exercise intolerance is very common in patients with coronary heart disease (CHD). Although some researches confirming the validation of traditional Chinese medicine (TCM) on CHD treatment, the effect of TCM on improving the exercise tolerance of patients with CHD remains unclear so far. Our trial is to investigate whether the Yangxinshi (YXS) tablet can improve exercise tolerance as well as the quality of life among CHD patients. METHODS: It is a randomized, double-blind, placebo-controlled, multi-center trial. A total of 90 patients with CHD from 3 hospitals in China will be enrolled and randomly assigned to one of 2 groups: YXS group, N = 45; placebo group, N = 45. The 2 groups will simultaneously receive standardized western medicine and exercise-based cardiac rehabilitation program for 12 weeks. The primary outcome measure is the exercise capacity, which will be evaluated by the cardiopulmonary exercise test and 6-minute walking test. The 2nd outcomes include symptom improvement, psychologic issues, laboratory tests, side effects, and adverse events. DISCUSSION: To our knowledge, it is the 1st randomized controlled trial to evaluate the effect of TCM YXS tablet on exercise tolerance in patients with CHD. The results will provide more evidence for future studies in this area. TRIAL REGISTRATION: This study protocol was registered in Research Registry (researchregistry5752).
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Zhang et al. (2020) conducted an RCT in Coronary heart disease (n=90). Yangxinshi tablet vs. Placebo was evaluated on Exercise capacity (VO2 peak and 6-minute walking test distance). This study protocol describes a planned randomized controlled trial to evaluate whether the Yangxinshi tablet improves exercise capacity in patients with coronary heart disease over 12 weeks.
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