NCT06727890尚未招募4 期
The Efficacy and Safety of Compound Danshen Dripping Pill in Patients With Diabetic Microvascular Angina
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 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 Compound Danshen Dripping Pill in patients with diabetic microvascular angina pectoris. Long-term follow-up of 1 year will be performed to evaluate the effect of Compound Danshen Dripping Pill 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of type 2 diabetes ≧5 years; Repeated chest pain attacks with typical exertional angina pectoris or resting angina pectoris attacks; Coronary normal or stenosis <50%; Ischemic depression in ST segment during resting or exercise; Coronary flow reserve (CFR) of the anterior descending coronary artery < 2.0, or CFR ≧2.0 but acetylcholine activation test is positive; Subjects or their guardians agreed to participate in this study.
排除标准
- •Previous myocardial infarction or PCI or CABG treatment; 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
Compound Danshen Dripping Pill
Experimental
干预措施: Danshen Dripping Pill (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (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: From baseline to the end of 12-month treatment
次要结局
未报告次要终点
研究者
Pan-Pan Hao
Dr.
Qilu Hospital of Shandong University
研究点 (3)
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