Rhodiola Rosea for Coronary Microvascular Disease

Shandong University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Coronary Microvascular Disease

Treatments: Drug: Placebo; Drug: Rhodiola Rosea Capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT04218916

Qilu Hospital

Details and patient eligibility

About

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.

Enrollment: 114 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Repeated chest pain attacks with typical exertional angina pectoris or resting angina pectoris attacks;
2. Coronary normal or stenosis < 20%;
3. Ischemic depression in ST segment during resting or exercise;
4. Blood flow reserve (CFR) of the anterior descending coronary artery < 2.0;
5. Subjects or their guardians agreed to participate in this study.

Exclusion criteria

1. Previous myocardial infarction or PCI or CABG treatment;
2. A history of heart failure or LVEF < 50%;
3. Severe arrhythmia;
4. Myocarditis, Pericardium Disease, Valvular Disease, or Cardiomyopathy;
5. A history of stroke within half a year;
6. Diabetes difficult to control;
7. Refractory hypertension or hypertension accompanied by left ventricular wall thickness > 12 mm;
8. Familial hypercholesterolemia;
9. Takayasu arteritis, Kawasaki disease or coronary artery malformation;
10. Pregnant or nursing, or having the intention to give birth within one year;
11. Hepatic or renal dysfunction;
12. Other diseases which may cause serious risks to patients;
13. Requiring warfarin anticoagulant therapy; Taking potassium channel opener, CCB, ACEI drugs or traditional Chinese medicines;
14. Allergic to contrast agents or blood products;
15. Patients who participated in clinical research of other drugs within 3 months before being selected.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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114 participants in 2 patient groups, including a placebo group

Rhodiola Rosea Capsule

Experimental group

Treatment:

Drug: Rhodiola Rosea Capsules

Placebo Capsule

Placebo Comparator group

Treatment:

Drug: Placebo