NCT04218916Unknown2 期
The Efficacy and Safety of Rhodiola Rosea in Patients With Coronary Microvascular Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 114
- 主要终点
- Changes of Coronary Flow Reserve
研究概览
简要总结
To investigate the effects of rhodiola rosea on coronary flow reserve and symptoms in patients with microvascular angina pectoris, and to evaluate adverse drug reactions. Long-term clinical follow-up of 1 to 3 years was conducted to evaluate the effect of rhodiola rosea on long-term 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 or LVEF < 50%;
- •Severe arrhythmia;
- •Myocarditis, Pericardium Disease, Valvular Disease, or Cardiomyopathy;
- •A history of stroke within half a year;
- •Diabetes difficult to control;
- •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;
- •Other diseases which may cause serious risks to patients;
- •Requiring warfarin anticoagulant therapy; Taking potassium channel opener, CCB, ACEI drugs or traditional Chinese medicines;
- •Allergic to contrast agents or blood products;
- •Patients who participated in clinical research of other drugs within 3 months before being selected.
研究组 & 干预措施
Rhodiola Rosea Capsule
Experimental
干预措施: Rhodiola Rosea Capsules (Drug)
Placebo Capsule
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Changes of Coronary Flow Reserve
时间窗: 1 year
次要结局
未报告次要终点
研究者
Pan-Pan Hao
MD
Qilu Hospital of Shandong University
相似试验
已完成
2 期
Rhodiola Crenulata as an Adjunctive Therapy in COPDCOPDNCT02242461Chung Shan Medical University57
撤回
2 期
Coronary Vasomotor Response After Riociguat ExposureCoronary Artery DiseaseNCT01165931Bayer
已完成
早期 1 期
The Effects of Rhus Coriaria L. on Serum Lipid Levels of Patients With HyperlipidemiaHyperlipidemiasNCT02295293Shiraz University of Medical Sciences74
进行中（未招募）
不适用
Rhodiola rosea Extract WS® 1375 in Subjects with Life Stress Symptomssubjects with life stress symptomsEUCTR2008-002134-29-GBDr. Willmar Schwabe GmbH & Co. KG100
已完成
不适用
Rhodiola rosea Extract WS® 1375 in subjects with chronic fatigue symptomsChronic fatigue symptomsSigns and SymptomsChronic fatigueISRCTN70529301Dr. Willmar Schwabe GmbH & Co. KG (Germany)100