دورية أكاديمية

Effects of Yangxinshi tablet on exercise tolerance in patients with coronary heart disease: A protocol of randomized, double-blind, placebo-controlled, and multi-center trial.

التفاصيل البيبلوغرافية
العنوان: Effects of Yangxinshi tablet on exercise tolerance in patients with coronary heart disease: A protocol of randomized, double-blind, placebo-controlled, and multi-center trial.
المؤلفون: Zhang S; Cardiovascular and Cardiac Rehabilitation Department, First Affiliated Hospital of Changchun Chinese Medicine University, Changchun City, Jilin Province., Liang C; Cardiovascular and Cardiac Rehabilitation Department, First Affiliated Hospital of Changchun Chinese Medicine University, Changchun City, Jilin Province., Yang Y; Cardiovascular and Cardiac Rehabilitation Department, First Affiliated Hospital of Changchun Chinese Medicine University, Changchun City, Jilin Province., Zhao Z; Cardiovascular and Cardiac Rehabilitation Department, First Affiliated Hospital of Changchun Chinese Medicine University, Changchun City, Jilin Province., Li J; Operating Room Department, Feicheng Mining Bureau Central Hospital, Tai'an City, Shandong Province, China., Meng X; Cardiovascular and Cardiac Rehabilitation Department, First Affiliated Hospital of Changchun Chinese Medicine University, Changchun City, Jilin Province.
المصدر: Medicine [Medicine (Baltimore)] 2020 Jul 31; Vol. 99 (31), pp. e21485.
نوع المنشور: Clinical Trial Protocol; Journal Article
اللغة: English
بيانات الدورية: Publisher: Lippincott Williams & Wilkins Country of Publication: United States NLM ID: 2985248R Publication Model: Print Cited Medium: Internet ISSN: 1536-5964 (Electronic) Linking ISSN: 00257974 NLM ISO Abbreviation: Medicine (Baltimore) Subsets: MEDLINE
أسماء مطبوعة: Original Publication: Hagerstown, Md : Lippincott Williams & Wilkins
مواضيع طبية MeSH: Coronary Disease*/physiopathology , Coronary Disease*/therapy , Drugs, Chinese Herbal*/administration & dosage , Exercise Tolerance*/drug effects , Medicine, Chinese Traditional*/methods, Adult ; Aged ; Female ; Humans ; Male ; Middle Aged ; China ; Double-Blind Method ; Exercise Test ; Quality of Life ; Randomized Controlled Trials as Topic ; Treatment Outcome ; Walk Test ; Multicenter Studies as Topic
مستخلص: 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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المشرفين على المادة: 0 (Drugs, Chinese Herbal)
0 (Yangxinshi)
تواريخ الأحداث: Date Created: 20200807 Date Completed: 20200824 Latest Revision: 20240329
رمز التحديث: 20240330
مُعرف محوري في PubMed: PMC7402915
DOI: 10.1097/MD.0000000000021485
PMID: 32756176
قاعدة البيانات: MEDLINE
الوصف
تدمد:1536-5964
DOI:10.1097/MD.0000000000021485