NCT01453582已完成3 期
Phase III Study of Total Flavonoids of Propolis Dropping Pill in Angina Pectoris: A Randomized, Double-Blind, Placebo-Controlled Multi-Centered Clinical Trial on Efficacy and Safety.
Shanghai Greenvalley Pharmaceutical Co., Ltd.13 个研究点 分布在 1 个国家目标入组 478 人开始时间: 2011年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 478
- 试验地点
- 13
- 主要终点
- Improvement of total exercise time of treadmill exercise test
研究概览
简要总结
The purpose of this study is to confirm the efficacy and safety of total flavonoids of propolis dropping pill to treat angina pectoris, evaluated by total exercise time of treadmill exercise test.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Class I, Class II and Class III stable angina pectoris, angina attack more than 3 times one week;
- •Qi deficiency and blood stasis syndrome of Traditional Chinese Medicine;
- •In resting electrocardiogram, ST-segment deviation≥0.05mv and/or T-wave inversion≥0.2mv in the leads R-wave is predominant during non-attack period, or ST-segment deviation≥0.1mv and/or T-wave inversion≥0.2mv in the leads R-wave is predominant during angina attack;
- •Total exercise time of treadmill exercise test≥3 minutes.The discontinuance standard should be reached. And the difference of total exercise time between before and after run in period should ≤15%;
- •Other confirmed diagnostic evidence of coronary heart disease, such as definite history of old myocardial infarction, or incomplete revascularization one year after coronary intervention therapy(residual luminal stenosis≥50%), or coronary angiography evidence(at least single vessel disease and luminal stenosis≥50%), or nuclein examination evidence, or computer tomography angiography evidence;
- •Signed the informed consent form.
排除标准
- •Chest pain caused by acute myocardial infarction(AMI), Class IV/serious angina pectoris, psychosis, serious neurosis, climacteric syndrome, hyperthyroidism, Cervical Spondylosis, gallbladder- heart syndrome, gastroesophageal reflux, hiatus hernia, aortic dissection, aortic valve disease;
- •Not well controlled hypertension(systolic pressure≥160mmHg，diastolic pressure≥100mmHg), serious cardiopulmonary insufficiency, serious arrhythmia(rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, etc);
- •Serious diseases of heart, lung, liver, kidney and blood;
- •Allergic constitution or allergic to the components of total Flavonoids of Propolis dropping pill;
- •Women during pregnancy or lactation;
- •Received any major operation within 4 weeks;
- •Have been in other clinical trials within 30 days;
- •Using but can not withdraw anti-angina medicine as long acting nitrates;
- •Not well controlled hyperglycemia;
- •Not fit for this trial judged by investigator.
研究组 & 干预措施
Propolis
Experimental
Total Flavonoids of Propolis dropping pill
干预措施: total Flavonoids of Propolis dropping pill (Drug)
Placebo
Placebo Comparator
Simulant of total Flavonoids of Propolis dropping pill
干预措施: total Flavonoids of Propolis dropping pill (Drug)
结局指标
主要结局
Improvement of total exercise time of treadmill exercise test
时间窗: -2 week, 0 weeks, 12 weeks
次要结局
- Duration of angina pectoris attack(-2 weeks, 0 week, 6 weeks, 12 weeks)
- Improvement of other indexes of treadmill exercise test(-2 weeks, 0 week, 12 weeks)
- Time to ST-segment deviation>1mm and positive symptoms appear(-2 weeks, 0 week, 12 weeks)
- The marked effective rate of angina pectoris(-2 weeks, 0 week, 6 weeks, 12 weeks)
- Attack times of angina pectoris(-2 weeks, 0 week, 6 weeks, 12 weeks)
- Pain degree of angina pectoris(-2 weeks, 0 week, 12 weeks)
- Dose change of nitroglycerin(-2 weeks, 0 week, 6 weeks, 12 weeks)
- The main symptoms of Chinese Traditional Medicine(-2 weeks, 0 week, 6 weeks, 12 weeks)
- Score change of the Seattle Angina Questionnaire (SAQ)(0 week, 12 weeks)
- Improvement of ECG(-2 weeks, 0 week, 12 weeks)
研究者
研究点 (13)
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