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STUDY PROTOCOL
Year : 2016  |  Volume : 1  |  Issue : 2  |  Page : 51-57

Efficacy of Qingxin Huatan therapy in regulating cardiac autonomic nerve function in patients with chronic stable angina: study protocol for a randomized controlled trial


Department of Emergency, Third Affiliated Hospital of Beijing University of Chinese Medicine, Beijing, China

Correspondence Address:
Hong-hao Ma
Department of Emergency, Third Affiliated Hospital of Beijing University of Chinese Medicine, Beijing
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2468-5658.184744

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Background: Coronary heart disease is a chronic degenerative disease of the coronary arteries characterized by atherosclerosis. Lianxia Ningxin granules, a traditional Chinese medicine, is a representative preparation of Qingxin Huatan therapy, which has been confirmed to be effective in improving autonomic nerve dysfunction in patients with coronary heart disease. Methods/Design: We herein describe a prospective, single-center, randomized, double-blind, placebo-controlled trial to be performed by the Department of Cardiovascular Medicine, Third Affiliated Hospital of Beijing University of Chinese Medicine, China. Eighty patients with chronic stable angina will be randomly assigned to receive 4 weeks of treatment with either Western medicine plus Lianxia Ningxin granules (traditional Chinese medicine group) or Western medicine plus placebo (control group). All patients will be followed up for 8 weeks. The primary outcome is frequency of angina attacks. The secondary outcomes include heart rate variability, plasma catecholamine concentrations, nitroglycerin consumption, duration of angina, severity of angina pain, efficacy of traditional Chinese medicine treatment, and quality of life. Discussion: This study is designed to assess the efficacy of Qingxin Huatan therapy in treating chronic stable angina, and simultaneously investigate the regulatory effects of this therapy on cardiac autonomic nerve function and related neurotransmitter concentrations. The outcomes will provide information concerning the clinical use of Qingxin Huatan therapy to treat chronic stable angina and its ability to regulate cardiac autonomic nervous function. Trial registration : This protocol was registered at the Chinese Clinical Trial Registry (registration number: ChiCTR-TRC-14004699). Ethics: Written approval has been obtained from the Medical Ethical Committee, Third Affiliated Hospital of Beijing University of Chinese Medicine, China (approval number: KTPJ-BZYSY-2003-003). Informed consent: Written informed consent will be obtained from patients or their guardians prior to inclusion in this study.


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