The Dose-Effect Relationship of Wenxin Granules in the Treatment of Atrial Premature Beats of Deficiency of Both Qi and Yin and Heart Vessel Stasis and Obstruction Syndrome : A Randomized, Double-blind, Placebo-controlled Clinical Trial Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Responder rate based on 24-hour Holter monitoring.
研究概览
简要总结
A Randomized, double-blind, placebo-controlled, four dose groups, post-marketing clinical trial, to evaluate the efficacy and safety of Wenxin granules in treating atrial premature beats by different doses,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 granules in treating atrial premature beats by different doses, to provide a scientific basis for rational clinical use of drug.
Research design: A Randomized, double-blind, placebo-controlled, four dose groups, post-marketing clinical trial.
Sample size:
The ratio of high, medium and low dose groups and placebo group were 1:1:1:1. A total of 60 cases were included in the first phase.The maximum sample size required was determined to be 150 cases.
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)
盲法说明
This study was a double-blind clinical trial, with the patients, the treating physicians, the statisticians, the monitors and any other personnel being unaware of group allocation. Efforts to maintain blinding included identical appearance, packaging and labeling of four groups of experimental drugs.
Unblinding should be done by the statisticians when the data collection process was completed or the treating physicians when serious adverse events occurred.
The maximum sample size required is determined to be 150 cases.
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 );
- •Accord with the diagnostic criteria of deficiency of both qi and yin and heart vessel stasis and obstruction Syndrome;
- •The number of premature beat of 24 h dynamic electrocardiogram >360 times/h or >8640 times/24h;
- •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
- •Serious condition that need to merge other anti-arrhythmic drugs(I,II,III,IV) to treat;
- •Heart rhythm disorders caused by the factors such as drugs ,electrolyte and acid-base balance disorders;
- •Merge tardy arrhythmia (including sick sinus syndrome and II degree atrioventricular block);
- •Removed predisposing factors (such as fatigue, nervousness, mood swings, alcoholism, etc.) the premature beats reduced, while the symptoms significantly relieved;
- •Patients who have pacemaker implanted or have undergone heart percutaneous coronary intervention (PCI) surgery;
- •Patients with severe hypotension;
- •Patients with serious cardiovascular diseases (such as congestive heart failure, cardiac shock, etc.), cerebrovascular disease, and serious primary 8.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;
- •Patients with chronic alcoholism , drug dependence, mental illness;
- •Participated in other clinical trials within 3 months.
研究组 & 干预措施
Low-dose Group
The intervention is half-dose of Wenxin Granules (1/2 normal dose).
干预措施: 1/2 Normal-dose Wenxin Granules (Drug)
Medium-dose Group
The intervention is medium-dose of Wenxin Granules (normal dose).
干预措施: Normal-dose Wenxin Granules (Drug)
High-dose Group
The intervention is twice-dose of Wenxin Granules (twice normal dose).
干预措施: Twice Normal-dose Wenxin Granules (Drug)
Placebo Group
The intervention is a placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Responder rate based on 24-hour Holter monitoring.
时间窗: Week 0 to Week 4
Defined as the proportion (%) of subjects with a ≥ 50% reduction in atrial premature beats during 24-hour Holter monitoring from baseline.
次要结局
- Responder rate(%) based on each symptom score.(Week 0 to Week 4)
- Change in Total Score From Baseline in Traditional Chinese Medicine Syndrome Score Scale.(Week 0 to Week 4)
研究者
Zhong Wang
Professor
China Academy of Chinese Medical Sciences