A Randomized, Double-blind, Multicenter, Parallel Controlled Clinical Trial of Danhong Injection in the Treatment of Unstable Angina Pectoris
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 9
- 主要终点
- Change from baseline of the Quantification score of angina pectoris at Day 7
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of Danhong injection in the treatment of unstable angina pectoris.
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)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male inpatients.
- •Age: 35 - 75 years.
- •Patients with clinical diagnosis of unstable stable angina according to China Guideline for the diagnosis and treatment of unstable angina (UA) and non-ST-elevation myocardial infarction (NSTEMI) (2007) issued by Chinese Society of Cardiology of Chinese Medical Association, including one of the following conditions.
- •Clinical diagnosis of "Xueyu Zheng" (Blood Stasis Syndrome) as the scores of Chinese medicine symptoms scales of "Xueyu Zheng" in UA ≥
- •The Chinese medicine symptoms scales of "Xueyu Zheng" is a 6-item questionnaire including the symtoms as following: (1)chest pain-10, (2)chest distress-10, (3) palpitation-5, (4)purple or dark lip-5, (5) purple or dark tongue-5, (6) unsmooth pulse-
- •Patient is willing to participate voluntarily and to sign a written patient informed consent.
排除标准
- •Patients with severe heart failure (EF<35%);
- •Patients with history of infection, fever, trauma, surgery(exclude PCI) and inflammation in the past month;
- •Patients with active tuberculosis or rheumatological disorders;
- •Patients with renal dysfunction (Male: CCr>2.5mg/dl; Female: CCr>2.0mg/dl);
- •Patients with liver dysfunction (any value of serum aminotransferase more than triple normal value);
- •Patients with history of hematopoietic system diseases;
- •Patients with mental disorder;
- •Patients with history of drug-induced bleeding or history of bleeding caused by warfarin;
- •Patients with malignant tumor;
- •Patients with history of organ transplant;
- •Woman with pregnancy, lactation or positive result of pregnancy test;
- •Patients who is participating in other trials or has been participated in other trials in recent 3 months;
- •Patients who were unable to participate in the study as judged by investigator.
研究组 & 干预措施
Danhong injection
Based on the standard medical care, 40ml of Danhong injection, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2-3 hours every day for 7 days.
干预措施: Danhong injection (Drug)
Danhong injection
Based on the standard medical care, 40ml of Danhong injection, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2-3 hours every day for 7 days.
干预措施: Standard medical care (Other)
Placebo
Based on the standard medical care, placebo was 40ml of 0.9% saline, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2-3 hours every day for 7 days.
干预措施: Standard medical care (Other)
Placebo
Based on the standard medical care, placebo was 40ml of 0.9% saline, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2-3 hours every day for 7 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline of the Quantification score of angina pectoris at Day 7
时间窗: Day 7
Quantification score of angina pectoris is a 4-item questionnaire that quantifies the frequency of angina, the duration of angina at every attack, the severity of angina and the use of nitroglycerin in a week. Scores range from 0 to 24; higher scores indicate worse health status.
次要结局
- Use of Short-acting Nitrates(Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 28)
- Change in the electrocardiogram (ECG)(Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 28)
- The proportion of patients who are undergoing PCI(Day 7, Day 28)
- Change in Seattle Angina Questionnaire(Day 0, Day 28)
- Incidence of adverse events (including serious adverse events) in 28 days(28 days)
- Total score of symptoms questionnaire of TCM(Day 0, Day 7)
研究者
Zhong Wang
Professor
China Academy of Chinese Medical Sciences