DaZhu Rhodiola Rosea Capsule for Coronary Artery Disease With Angina Pectoris

Capital Medical University

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: DaZhu Rhodiola Rosea Capsule; Drug: DaZhu Rhodiola Rosea Simulation Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT03633890

2017032

Details and patient eligibility

About

This study aims to evaluate the efficacy and safety of traditional Chinese medicine DaZhu Rhodiola Rosea Capsule for treatment of coronary artery disease by observing angina symptoms, exercise capacity, and quality of life.

Enrollment: 102 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 to 75 years old
• Coronary heart disease with grade Ⅱ or Ⅲ stable or unstable angina (≥ 2 times per week), or residual angina-like symptoms 1 month to 1 year post percutaneous coronary intervention (PCI) or 3 months to 1 year post coronary artery bypass surgery (CABG)
• Written informed consent

Exclusion criteria

• Acute myocardial infarction within 1 month before admission
• Patients who plan to undergo revascularization in the next 3 months
• Congestive heart failure, acute myocarditis or pericarditis, thrombophlebitis, pulmonary embolism, or severe neurosis within 3 months prior to admission
• Patients with uncontrolled high blood pressure (systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg), severe cardiopulmonary insufficiency (cardiac function grade Ⅲ, Ⅳ or left ventricular ejection fraction (LVEF) < 40%), severe arrhythmia (rapid atrial fibrillation and flutter, paroxysmal ventricular tachycardia, degree Ⅱ type Ⅱ and degree Ⅲ atrioventricular block, etc.)
• Severe liver, kidney and hematopoietic system dysfunction or psychosis (serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times the normal upper limit, or serum creatinine > 1.5 times the normal upper limit)
• History of bleeding or treatment with warfarin
• Implanted pacemakers
• Pregnant or lactating women
• Allergic to study drugs
• Legal disability (blindness, deafness, dumbness, intellectual disability, mental disability, physical disability)
• Patients who participated in other clinical trials within 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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102 participants in 2 patient groups, including a placebo group

DaZhu Rhodiola Rosea Capsule

Experimental group

Treatment:

Drug: DaZhu Rhodiola Rosea Capsule

DaZhu Rhodiola Rosea Simulation Capsule

Placebo Comparator group

Treatment:

Drug: DaZhu Rhodiola Rosea Simulation Capsule