Efficacy and Safety of Jiuxin Pill in the Treatment of Patients with Stable Angina Pectoris: A Protocol for a Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial

Tongzuo Liu,1,2,* Jingyi Zhang,1,2,* Zhiqiang Zhao,1 Yingfei Bi,1 Ying Zheng,1 Shuai Wang,1 Xiaohua Dai,3 Jun Li,4 Qian Lin,5 Daimei Ni,6 Chenglong Wang,7 Jianguang Wu,8 Yitao Xue,9 Mingjun Zhu,10 Xianliang Wang,1,* Jingyuan Mao1,* 1Cardiovascular Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine/National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, People’s Republic of China; 2Graduate School, Tianjin University of Traditional Chinese Medicine, Tianjin, People’s Republic of China; 3Cardiovascular Department, The First Affiliated Hospital of Anhui University of Chinese Medicine, Anhui, People’s Republic of China; 4Cardiovascular Department, Guang’anmen Hospital of China Academy of Chinese Medicine Science, Beijing, People’s Republic of China; 5Cardiovascular Department, Dongzhimen Hospital of Beijing University of Chinese Medicine, Beijing, People’s Republic of China; 6Cardiovascular Department, Taihe Hospital of Traditional Chinese Medicine Affiliated to Anhui University of Chinese Medicine, Anhui, People’s Republic of China; 7Cardiovascular Department, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing, People’s Republic of China; 8Cardiovascular Department, Affiliated Hospital of Jiangxi University of Chinese Medicine, Jiangxi, People’s Republic of China; 9Cardiovascular Department, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Shandong, People’s Republic of China; 10Cardiovascular Department, The First Affiliated Hospital of He’nan University of Traditional Chinese Medicine, Henan, People’s Republic of China*These authors contributed equally to this workCorrespondence: Jingyuan Mao; Xianliang Wang, Cardiovascular Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine/National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, People’s Republic of China, Tel +86-13820498886 ; +86-13920007825, Email [email protected]; [email protected]: Stable angina pectoris (SAP), as a common type of coronary heart disease (CHD), is characterized by transient retrosternal squeezing pain or suffocation induced by exercise, mood swings, or other stress. Most patients with stable angina pectoris do not benefit from interventional therapy and medication, so optimizing treatment plans has important clinical significance. Jiuxin pill is a Chinese patent medicine developed by Huatuo Chinese Medicine Co. Ltd. (Bozhou, China) to relieve the symptoms of stable angina pectoris (SAP). However, there is a lack of evidence support from high-quality clinical studies.Methods: In this randomized, double-blind, placebo-controlled, multicenter clinical trial, 170 patients with SAP were recruited from 11 centers in China. The patients were randomized to either the treatment group (Jiuxin pill, 2 pills, bid) or the control group (Jiuxin pill simulant, 2 pills, bid) without changing the original conventional western medicine. The trial was set up with a run-in period of 7 days, a treatment period of 28 ± 2 days, and a follow-up period of 28 ± 2 days. Total exercise time (TED) in the treadmill test and Seattle Angina Questionnaire (SAQ) scores were set as the main efficacy outcomes, and the 1-minute heart rate recovery (HRR1), metabolic equivalents (METs), maximum ST segment depression, Borg perceived exertion after exercise, the average number of angina attacks per week, usage of nitroglycerin, drug withdrawal and reduction rate, information scoring of four diagnostic methods in traditional Chinese medicine and incidence of major adverse cardiovascular events were set as the secondary efficacy outcomes. Adverse events were monitored throughout the trial.Discussion: In China, the use of Chinese patent medicine in the treatment of stable angina pectoris is more common. This trial evaluated the efficacy and safety of the Jiuxin pill in the treatment of patients with SAP, and the trial results provide high-quality research evidence for its clinical application.Trial Registration: This trial has been registered in the China Clinical Trial Registry on 11 June 2022 (Registration No.: ChiCTR2200060780, https://www.chictr.org.cn/showproj.html?proj=172352).Keywords: traditional Chinese medicine, Jiuxin pill, stable angina pectoris, protocol, randomized controlled trial