Efficacy and safety of Naoxintong capsule for treating chronic stable angina: study protocol for a randomized controlled trial

Abstract Background Cardiovascular disease is the leading cause of mortality and morbidity worldwide, Chronic stable angina (CSA) is the main symptom of myocardial ischemia, causes increased risk of major cardiovascular events such as sudden cardiac death and myocardial infarction. Naoxintong (NXT)...

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Main Authors: Gao Huanjia, Cai Hairong, Zhuang Jieqin, Dai Xingzhen, Fu Xue, Zhang Weizhang, Chen Bojun
Format: Article
Language:English
Published: BMC 2021-05-01
Series:Trials
Subjects:
Online Access:https://doi.org/10.1186/s13063-021-05264-y
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spelling doaj-014b39b3275e4ee9ac762c5158d544b82021-05-11T14:55:46ZengBMCTrials1745-62152021-05-012211810.1186/s13063-021-05264-yEfficacy and safety of Naoxintong capsule for treating chronic stable angina: study protocol for a randomized controlled trialGao Huanjia0Cai Hairong1Zhuang Jieqin2Dai Xingzhen3Fu Xue4Zhang Weizhang5Chen Bojun6The Second Clinical College of Guangzhou University of Chinese MedicineThe Second Clinical College of Guangzhou University of Chinese MedicineThe Second Affiliated Hospital of Guangzhou University of Traditional Chinese MedicineThe Second Affiliated Hospital of Guangzhou University of Traditional Chinese MedicineThe Second Affiliated Hospital of Guangzhou University of Traditional Chinese MedicineThe Second Affiliated Hospital of Guangzhou University of Traditional Chinese MedicineThe Second Affiliated Hospital of Guangzhou University of Traditional Chinese MedicineAbstract Background Cardiovascular disease is the leading cause of mortality and morbidity worldwide, Chronic stable angina (CSA) is the main symptom of myocardial ischemia, causes increased risk of major cardiovascular events such as sudden cardiac death and myocardial infarction. Naoxintong (NXT) capsule is a classical traditional Chinese medication used to treat CSA, however, few evidence to support the wide utility of NXT capsule for the treatment of CSA. We design this study to evaluate the efficacy and safety of NXT capsule versus placebo in patients with CSA. Methods/design This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. A total of 260 eligible participants will be enrolled. The participants will be randomized assigned in an equal ratio to groups receiving either NXT or placebo for 12 weeks. After a 2-week run-in period, they will receive either NXT or placebo (3 pills, 3 times daily) for 12 weeks. The primary outcome is therapeutic efficacy. Secondary outcome measures include the quantitative score of TCM syndromes, severity grading of angina pectoris, the number of angina pectoris per week, nitroglycerin dosage, score of Seattle angina scale, serum homocysteine, and incidence of cardiovascular events. Safety outcomes and adverse events will be monitored throughout the trial. Discussion We designed this study in accordance with principles and regulations issued by the China Food and Drug Administration (CFDA). The results will provide clinical evidence of the efficacy and safety of NXT Capsule in the treatment of CSA. Trial registration Chinese Clinical Trial Registry ChiCTR2100044563 . Registered on 24 March 2020.https://doi.org/10.1186/s13063-021-05264-yChronic stable anginaNaoxintong capsuleTraditional Chinese medicineRandomized controlled trial
collection DOAJ
language English
format Article
sources DOAJ
author Gao Huanjia
Cai Hairong
Zhuang Jieqin
Dai Xingzhen
Fu Xue
Zhang Weizhang
Chen Bojun
spellingShingle Gao Huanjia
Cai Hairong
Zhuang Jieqin
Dai Xingzhen
Fu Xue
Zhang Weizhang
Chen Bojun
Efficacy and safety of Naoxintong capsule for treating chronic stable angina: study protocol for a randomized controlled trial
Trials
Chronic stable angina
Naoxintong capsule
Traditional Chinese medicine
Randomized controlled trial
author_facet Gao Huanjia
Cai Hairong
Zhuang Jieqin
Dai Xingzhen
Fu Xue
Zhang Weizhang
Chen Bojun
author_sort Gao Huanjia
title Efficacy and safety of Naoxintong capsule for treating chronic stable angina: study protocol for a randomized controlled trial
title_short Efficacy and safety of Naoxintong capsule for treating chronic stable angina: study protocol for a randomized controlled trial
title_full Efficacy and safety of Naoxintong capsule for treating chronic stable angina: study protocol for a randomized controlled trial
title_fullStr Efficacy and safety of Naoxintong capsule for treating chronic stable angina: study protocol for a randomized controlled trial
title_full_unstemmed Efficacy and safety of Naoxintong capsule for treating chronic stable angina: study protocol for a randomized controlled trial
title_sort efficacy and safety of naoxintong capsule for treating chronic stable angina: study protocol for a randomized controlled trial
publisher BMC
series Trials
issn 1745-6215
publishDate 2021-05-01
description Abstract Background Cardiovascular disease is the leading cause of mortality and morbidity worldwide, Chronic stable angina (CSA) is the main symptom of myocardial ischemia, causes increased risk of major cardiovascular events such as sudden cardiac death and myocardial infarction. Naoxintong (NXT) capsule is a classical traditional Chinese medication used to treat CSA, however, few evidence to support the wide utility of NXT capsule for the treatment of CSA. We design this study to evaluate the efficacy and safety of NXT capsule versus placebo in patients with CSA. Methods/design This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. A total of 260 eligible participants will be enrolled. The participants will be randomized assigned in an equal ratio to groups receiving either NXT or placebo for 12 weeks. After a 2-week run-in period, they will receive either NXT or placebo (3 pills, 3 times daily) for 12 weeks. The primary outcome is therapeutic efficacy. Secondary outcome measures include the quantitative score of TCM syndromes, severity grading of angina pectoris, the number of angina pectoris per week, nitroglycerin dosage, score of Seattle angina scale, serum homocysteine, and incidence of cardiovascular events. Safety outcomes and adverse events will be monitored throughout the trial. Discussion We designed this study in accordance with principles and regulations issued by the China Food and Drug Administration (CFDA). The results will provide clinical evidence of the efficacy and safety of NXT Capsule in the treatment of CSA. Trial registration Chinese Clinical Trial Registry ChiCTR2100044563 . Registered on 24 March 2020.
topic Chronic stable angina
Naoxintong capsule
Traditional Chinese medicine
Randomized controlled trial
url https://doi.org/10.1186/s13063-021-05264-y
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