Trial | NCT03633890  Report issue

Title

DaZhu Rhodiola Rosea Capsule for Coronary Artery Disease With Angina Pectoris
A Randomized, Double-Blind, Placebo-Controlled Trial for DaZhu Rhodiola Rosea Capsule in the Treatment of Coronary Artery Disease With Angina Pectoris

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    102
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.
Study Started
Aug 31
2018
Anticipated
Primary Completion
Feb 28
2019
Anticipated
Study Completion
Feb 28
2019
Anticipated
Last Update
Aug 16
2018

Drug DaZhu Rhodiola Rosea Capsule

Oral administration, 4 capsules, 3 times a day, for 8 weeks

Drug DaZhu Rhodiola Rosea Simulation Capsule

Oral administration, 4 capsules, 3 times a day, for 8 weeks

DaZhu Rhodiola Rosea Capsule Experimental

DaZhu Rhodiola Rosea Simulation Capsule Placebo Comparator

Criteria 

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
No Results Posted