Abstract
Background Coronary heart disease (CHD) and abnormal glucose and lipid metabolism are closely associated and generally coexist. The Qi and Yin deficiency syndrome is a common disease pattern encountered in traditional Chinese medicine. We designed a protocol to determine the effectiveness and safety of Zhenyuan capsules for CHD with abnormal glucose and lipid metabolism. Methods This multicenter, randomized, double-blind, parallel-controlled trial was designed in accordance with the CONSORT. We will recruit 200 eligible male patients aged 45–75 years from three participating centers and randomly assign them to treatment and control groups (1 : 1). The primary indicators are glycosylated hemoglobin, fasting blood glucose, 2-hour postprandial blood glucose, and triglyceride levels. The secondary indicators are the Seattle Angina Questionnaire, TCM symptom indicators, ultrasonic cardiography finding, coagulation indicator, and P-selectin level. Measurements will be performed at baseline (T0), the end of the run-in period (T1), and weeks 4 (T2), 8 (T3), and 12 (T4) of the treatment period. Adverse events will be monitored during the trial. Discussion This study aims to evaluate the efficacy and safety of Zhenyuan capsules in patients with CHD and abnormal glucose and lipid metabolism. The results will provide critical evidence of the usefulness of the Chinese herbal medicine for CHD with abnormal glucose and lipid metabolism. Trial Registration This trial is registered with the Chinese Clinical Trials Registry, with identifier number ChiCTR-TRC-14004639, May 4, 2014.
Highlights
Treatment of coronary heart disease (CHD), which poses a significant threat worldwide, has made great progress, including thrombolysis, intervention, and coronary artery bypass grafting
The 10-year follow-up results of the UK Prospective Diabetes Study showed that patients with intensive glucose control initially showed risk reduction for any diabetes-related end-point by 9% (P = 0.04), microvascular disease by 24% (P = 0.001), myocardial infarction by 15% (P = 0.01), and all-cause mortality by 13% (P = 0.007)
Many studies have used the Zhenyuan capsule as treatment for Coronary heart disease (CHD), heart failure [11], and type 2 diabetes [12] with Qi deficiency or blood stasis
Summary
Treatment of coronary heart disease (CHD), which poses a significant threat worldwide, has made great progress, including thrombolysis, intervention, and coronary artery bypass grafting. The 10-year follow-up results of the UK Prospective Diabetes Study showed that patients with intensive glucose control initially showed risk reduction for any diabetes-related end-point by 9% (P = 0.04), microvascular disease by 24% (P = 0.001), myocardial infarction by 15% (P = 0.01), and all-cause mortality by 13% (P = 0.007). Early detection and intervention in diabetes are important measures to reduce the morbidity of myocardial infarction and decrease mortality in CHD patients. Coronary heart disease (CHD) and abnormal glucose and lipid metabolism are closely associated and generally coexist. This study aims to evaluate the efficacy and safety of Zhenyuan capsules in patients with CHD and abnormal glucose and lipid metabolism. The results will provide critical evidence of the usefulness of the Chinese herbal medicine for CHD with abnormal glucose and lipid metabolism. This trial is registered with the Chinese Clinical Trials Registry, with identifier number ChiCTR-TRC-14004639, May 4, 2014
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