NCT06699420招募中4 期
The Efficacy and Safety of Qishenyiqi Dripping Pill in Patients With Coronary Microvascular Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 162
- 试验地点
- 3
- 主要终点
- Changes of coronary flow reserve measured by three-dimensional echocardiography from baseline to 12 months after follow-up
研究概览
简要总结
To investigate the efficacy and safety of Qishenyiqi in patients with microvascular angina pectoris. Long-term follow-up of 1 year will be performed to evaluate the effect of Qishenyiqi on coronary flow reserve and adverse cardiovascular events in patients with coronary microvascular disease.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Repeated chest pain attacks with typical exertional angina pectoris or resting angina pectoris attacks;
- •Coronary normal or stenosis < 20%;
- •Ischemic depression in ST segment during resting or exercise;
- •Blood flow reserve (CFR) of the anterior descending coronary artery < 2.0;
- •Subjects or their guardians agreed to participate in this study.
排除标准
- •Previous myocardial infarction or PCI or CABG treatment;
- •A history of heart failure;
- •Severe arrhythmia;
- •Refractory hypertension or hypertension accompanied by left ventricular wall thickness > 12 mm;
- •Familial hypercholesterolemia;
- •Takayasu arteritis, Kawasaki disease or coronary artery malformation;
- •Pregnant or nursing, or having the intention to give birth within one year;
- •Hepatic or renal dysfunction;
- •Allergic to contrast agents or traditional Chinese medicines;
- •Patients who participated in clinical research of other drugs within 3 months before being selected.
研究组 & 干预措施
Qishenyiqi Dripping Pill
Experimental
干预措施: Qishenyiqi dripping pills 1 bag, three times a day (Drug)
Placebo
Placebo Comparator
干预措施: Placebo 1 bag, three times a day (Drug)
结局指标
主要结局
Changes of coronary flow reserve measured by three-dimensional echocardiography from baseline to 12 months after follow-up
时间窗: 1 year
次要结局
未报告次要终点
研究者
Pan-Pan Hao
Prof.
Qilu Hospital of Shandong University
研究点 (3)
Loading locations...
相似试验
已完成
2 期
Efficacy and Safety of Qishenyiqi Dripping Pills for Treating Chronic Heart Failure With Preserved Ejection FractionChronic Heart Failure With Preserved Ejection FractionNCT04944706Tasly Pharmaceutical Group Co., Ltd225
尚未招募
4 期
Tongxinluo Capsule for Coronary Microvascular DiseaseCoronary Microvascular DiseaseNCT04220372Qilu Hospital of Shandong University100
尚未招募
4 期
Qishenyiqi for Ventricular Remodeling After Myocardial InfarctionChronic Stable Heart FailureNCT06699407Qilu Hospital of Shandong University210
Unknown
4 期
Effect of Shexiang Tongxin Dropping Pills on Microcirculation in Patients With AMIAcute Myocardial InfarctionNCT04952259Peking University Third Hospital60
招募中
2 期
Efficacy and Safety of QiShen YiQi Dripping Pills in the Treatment of Diabetic Kidney Disease (Syndrome of Qi Deficiency With Blood Stasis)Diabetic Kidney DiseaseNCT06006689Tasly Pharmaceutical Group Co., Ltd228