Mingwang Liu , Yangfang Zhang , Beili Xie , Lulian Jiang , Haohao Li , Jianpeng Du , Dawu Zhang , Zikai Yu , Yuxin Yan , Keji Chen , Fuhai Zhao
{"title":"冠状动脉微血管疾病芳香和热身管理（AWARD）的原理和设计：多中心、随机、双盲、安慰剂对照临床试验的研究方案","authors":"Mingwang Liu , Yangfang Zhang , Beili Xie , Lulian Jiang , Haohao Li , Jianpeng Du , Dawu Zhang , Zikai Yu , Yuxin Yan , Keji Chen , Fuhai Zhao","doi":"10.1016/j.eujim.2024.102393","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><p>Current treatments for coronary microvascular disease (CMVD) have limited efficacy. Kuanxiong Aerosol (KXA), a representative preparation used for aromatic and warming-up management, is a typical Chinese proprietary medicine that relieves the symptoms of angina pectoris and contributes to improving coronary microcirculation disorders, which may provide an option for the treatment of CMVD.</p></div><div><h3>Methods</h3><p>This is a prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial. A total of 120 eligible patients will be randomized 1:1 to KXA or placebo groups and receive 30-day interventions and follow-up. The primary outcome will be the Seattle Angina Scale score. Secondary outcomes will be the TCM (traditional Chinese medicine) syndrome score, self-rated anxiety scale score, self-rated depression scale, microcirculation function, and laboratory index for coronary microvascular.</p></div><div><h3>Discussion</h3><p>This trial will evaluate the clinical efficacy and safety of KXA in the treatment of CMVD. The results of this study may provide clinical evidence for the use of Chinese patent medicine in CMVD.</p></div><div><h3>Trial registration</h3><p>Chinese Clinical Trial Registry ChiCTR2200057494</p></div>","PeriodicalId":11932,"journal":{"name":"European Journal of Integrative Medicine","volume":"70 ","pages":"Article 102393"},"PeriodicalIF":1.9000,"publicationDate":"2024-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1876382024000623/pdfft?md5=d0728c05a1ac5bcd2aa665b3bc7a3466&pid=1-s2.0-S1876382024000623-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Rationale and design of aromatic and warming-up management in coronary microvascular disease (AWARD): A study protocol for a multicenter, randomized, double-blind, placebo-controlled clinical trial\",\"authors\":\"Mingwang Liu , Yangfang Zhang , Beili Xie , Lulian Jiang , Haohao Li , Jianpeng Du , Dawu Zhang , Zikai Yu , Yuxin Yan , Keji Chen , Fuhai Zhao\",\"doi\":\"10.1016/j.eujim.2024.102393\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Introduction</h3><p>Current treatments for coronary microvascular disease (CMVD) have limited efficacy. Kuanxiong Aerosol (KXA), a representative preparation used for aromatic and warming-up management, is a typical Chinese proprietary medicine that relieves the symptoms of angina pectoris and contributes to improving coronary microcirculation disorders, which may provide an option for the treatment of CMVD.</p></div><div><h3>Methods</h3><p>This is a prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial. A total of 120 eligible patients will be randomized 1:1 to KXA or placebo groups and receive 30-day interventions and follow-up. The primary outcome will be the Seattle Angina Scale score. Secondary outcomes will be the TCM (traditional Chinese medicine) syndrome score, self-rated anxiety scale score, self-rated depression scale, microcirculation function, and laboratory index for coronary microvascular.</p></div><div><h3>Discussion</h3><p>This trial will evaluate the clinical efficacy and safety of KXA in the treatment of CMVD. 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Rationale and design of aromatic and warming-up management in coronary microvascular disease (AWARD): A study protocol for a multicenter, randomized, double-blind, placebo-controlled clinical trial
Introduction
Current treatments for coronary microvascular disease (CMVD) have limited efficacy. Kuanxiong Aerosol (KXA), a representative preparation used for aromatic and warming-up management, is a typical Chinese proprietary medicine that relieves the symptoms of angina pectoris and contributes to improving coronary microcirculation disorders, which may provide an option for the treatment of CMVD.
Methods
This is a prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial. A total of 120 eligible patients will be randomized 1:1 to KXA or placebo groups and receive 30-day interventions and follow-up. The primary outcome will be the Seattle Angina Scale score. Secondary outcomes will be the TCM (traditional Chinese medicine) syndrome score, self-rated anxiety scale score, self-rated depression scale, microcirculation function, and laboratory index for coronary microvascular.
Discussion
This trial will evaluate the clinical efficacy and safety of KXA in the treatment of CMVD. The results of this study may provide clinical evidence for the use of Chinese patent medicine in CMVD.
期刊介绍：
The European Journal of Integrative Medicine (EuJIM) considers manuscripts from a wide range of complementary and integrative health care disciplines, with a particular focus on whole systems approaches, public health, self management and traditional medical systems. The journal strives to connect conventional medicine and evidence based complementary medicine. We encourage submissions reporting research with relevance for integrative clinical practice and interprofessional education.
EuJIM aims to be of interest to both conventional and integrative audiences, including healthcare practitioners, researchers, health care organisations, educationalists, and all those who seek objective and critical information on integrative medicine. To achieve this aim EuJIM provides an innovative international and interdisciplinary platform linking researchers and clinicians.
The journal focuses primarily on original research articles including systematic reviews, randomized controlled trials, other clinical studies, qualitative, observational and epidemiological studies. In addition we welcome short reviews, opinion articles and contributions relating to health services and policy, health economics and psychology.
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