A Randomized, Double-blind, Two Dose Group, Parallel-control Multi-center, Post-marketing Clinical Trial,to Evaluate the Efficacy and Safety of Wenxin Keli in Treating Atrial Premature Beats.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- 24 h dynamic electrocardiogram (Holter)
研究概览
简要总结
A randomized, double-blind, two dose group, parallel-control multi-center, post-marketing clinical trial，to evaluate the efficacy and safety of Wenxin keli in treating atrial premature beats by different dose,to provide a scientific basis for rational clinical use of drug.
详细描述
Research purpose： To evaluate the efficacy and safety of Wenxin keli in treating atrial premature beats by different dose,to provide a scientific basis for rational clinical use of drug.
Research design： A randomized, double-blind, two dose group, parallel-control multi-center, post-marketing clinical trial.
Sample size:
A total of 288 subjects, 144cases in each group.
Therapeutic schedule:
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Accord with the diagnostic criteria of arrhythmia (atrial premature beats )
- •The average number of premature beat of 24 h dynamic electrocardiogram >360 times/h (effective record at least 22 h)
- •Stop using the anti- arrhythmic drugs for more than five half-life (except that who long-term (one month or more) with beta blockers for high blood pressure and exertional angina)
- •Ages 18 to 75 years old ,all genders
- •Voluntary subjects and signed the informed consent form
排除标准
- •Need to merge other anti-arrhythmic drugs(Ⅰ,Ⅱ,Ⅲ,Ⅳ) for serious condition
- •Heart rhythm disorders caused by the factors such as drugs ,electrolyte and acid-base balance disorders
- •Merge tardy arrhythmia (including sick sinus syndrome and Ⅱdegree atrioventricular block)
- •Patients have had heart percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) surgery
- •Patients with severe hypotension
- •With serious cardiovascular diseases (severe coronary heart disease, congenital heart disease, cardiomyopathy, myocardial infarction, congestive heart failure, cardiac shock, etc.), cerebrovascular disease, severe respiratory diseases (chronic obstructive pulmonary disease, pulmonary hypertension, pulmonary embolism, etc.),serious primary diseases such as liver, kidney and hematopoietic system (ALT,AST,BUN 2 times higher than normal ceiling, or Cr higher than the upper limit of normal)
- •Allergic constitution; the test drug allergy or its ingredients or elements allergy
- •Pregnancy and lactation women ,recent preparation pregnancy
- •With chronic alcoholism , drug dependence, mental illness
- •Participated in other clinical trials within 3 months
- •Patients thought by the investigators not suitable to participate in clinical trials
研究组 & 干预措施
Low dose WenXin keli
Low dose group (the original quantity Wenxin keli): specification 10g /bag, Wenxin keli (no sugar) 5 g+ Wenxin keli simulation agent 5g.
Oral ,1 bag each time, 3 times a day, 4 weeks for 1 course of treatment.
干预措施: Low dose WenXin keli (Drug)
High dose WenXin keli
High dose group(2 times the amount of Wenxin keli): specification 10g /bag, Wenxin keli (no sugar) 10 g.
Oral ,1 bag each time, 3 times a day, 4 weeks for 1 course of treatment.
干预措施: High dose WenXin keli (Drug)
结局指标
主要结局
24 h dynamic electrocardiogram (Holter)
时间窗: Baseline, up to 4 weeks, each record at a time.
Baseline, up to 4 weeks, each record at a time.
次要结局
- Symptom scores(Baseline, up to 4 weeks, each record at a time.)