NCT04421287Unknown4 期
Clinical Study on the Effect of Zhenyuan Capsule on Cardiopulmonary Function in Patients With Stable Coronary Heart Disease With Qi Deficiency and Blood Stasis
Xiyuan Hospital of China Academy of Chinese Medical Sciences1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年6月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Cardiopulmonary function index change
研究概览
简要总结
A randomized, double-blind, placebo trial was adopted, and cardiopulmonary exercise load test (CPET) was used to detect peak oxygen uptake (PeakVO2) and exercise metabolic equivalent (METs) to confirm the clinical effect of Zhenyuan capsule on improving cardiopulmonary endurance in patients with coronary heart disease of qi deficiency and blood stasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double mind
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Results of coronary angiography or spiral CT:Patients with coronary artery stenosis ≥ 50%, or with a clear history of myocardial infarction, or stable condition more than one month after ACS treatment (percutaneous coronary intervention therapy, PCI, coronary artery bypass graft, CABG)；
- •LVEF≥40%；
- •Angina grade Ⅰ-Ⅱ (CCS grade);
- •The syndrome differentiation of traditional Chinese medicine is the syndrome of qi deficiency and blood stasis；
- •18 years old ≤ age ≤ 75 years old；
- •In accordance with the risk stratification of cardiac rehabilitation in patients with coronary heart disease, the patients with moderate and low risk can carry out cardiopulmonary rehabilitation by exercise；
- •Those who sign the informed consent form.
排除标准
- •Patients with acute myocardial infarction or unstable angina pectoris, or within one month after PCI or CABG;
- •Patients with absolute and relative contraindications in accordance with cardiopulmonary exercise test;
- •Patients who took Zhenyuan capsule in the past 1 month or participated in other clinical trials in the past 1 month；
- •Renal insufficiency, serum creatinine > 2.5mg / dl in male and > 2.0mg/dl in female；
- •Patients with obvious liver disease or both ALT and AST were 3 times higher than the normal upper limit；
- •New York heart function (NYHA) grade IV, or patients with recurrent malignant arrhythmias;
- •Complicated with chronic obstructive pulmonary disease or even respiratory failure, or complicated with pulmonary infection;
- •Diabetic patients with random blood glucose ≥ 13.7mmol/L or glycosylated hemoglobin ≥ 9.5%;
- •Pregnant or preparing pregnant women, lactating women;
- •Patients with acute cerebrovascular diseases; malignant tumors or patients with life expectancy of less than 1 year; patients with severe hematopoietic diseases; patients with severe mental illness;
- •For those who are allergic to the known ingredients of the drug.
研究组 & 干预措施
Zhenyuan capsule
Experimental
干预措施: Zhenyuan capsule (Drug)
Zhenyuan capsule placebo
Placebo Comparator
干预措施: Zhenyuan capsule (Drug)
结局指标
主要结局
Cardiopulmonary function index change
时间窗: Change from Baseline VO2 peak at 12 weeks / 16 weeks after drug treatment;
Peak Oxygen Uptake（Peak VO2）；Heart rate、Stroke volume and arteriovenous oxygen difference will be combined to report VO2 peak in mL/kg/min(milliliters of oxygen per kilogram of body weight per minute )；
次要结局
未报告次要终点
研究者
研究点 (1)
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