Analysis on Clinical Trial Registration of TCM in the Treatment of Coronary Artery Microvascular Diseases
10.19879/j.cnki.1005-5304.202402091
- VernacularTitle:中医药治疗冠状动脉微血管疾病临床试验注册现况分析
- Author:
Zhao GE
1
;
Silin REN
;
Mengxue ZHOU
;
Mohan LI
;
Xujin NING
;
Xianliang WANG
Author Information
1. 天津中医药大学第一附属医院,国家中医针灸临床医学研究中心,天津 300381;天津中医药大学研究生院,天津 301617
- Publication Type:Journal Article
- Keywords:
coronary artery microvascular disease;
microvascular angina;
no reflow;
slow blood flow;
non-obstructive coronary artery disease;
TCM;
China Clinical Trials Registry;
US Clinical Trials Registry
- From:
Chinese Journal of Information on Traditional Chinese Medicine
2025;32(3):64-68
- CountryChina
- Language:Chinese
-
Abstract:
Objective To review clinical trial registration status of TCM treatment for coronary microvascular disease;To analyze the effectiveness and safety of TCM in treating coronary microvascular disease.Methods The clinical trials of TCM in the treatment of coronary artery microvascular disease included in the Chinese Clinical Trials Registry and the US Clinical Trials Registry from the establishment of the database to January 31,2024 were retrieved,and the general characteristics(time,region,funding source),design type,intervention regimen and outcome indicators of the included clinical trials were extracted and analyzed using Excel 2019 software.Results A total of 17 clinical trials were included,including 16 pre-registrations.The registered units were distributed in 5 provinces across the country,involving 17 registration institutions.The two regions with the most distribution were Shanghai(6 studies,35.29%)and Beijing(5 studies,29.41%).The types of studies were mainly interventional studies,and most of the study designs were randomized parallel controlled studies(16 studies,94.12%).A total of 8 interventions were reported,including Chinese patent medicine,TCM decoction,TCM intravenous preparation,and acupuncture and moxibustion.A total of 143 outcome indicators were designed,including 10 first-level indicators,including coronary artery microcirculation,clinical efficacy,symptoms and signs,TCM syndromes,quality of life,exercise tolerance,cardiac function,physical and chemical testing,safety,and pharmacoeconomic evaluation.Conclusion The registration of clinical trials by TCM in the treatment of coronary microvascular diseases has been gradually receiving attention from researchers,but the overall number is still small.At present,the study needs to be optimized in terms of study design and index selection.
