DaZhu Rhodiola Rosea Capsule for Coronary Artery Disease With Angina Pectoris

Study Overview
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Brief Summary
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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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: DaZhu Rhodiola Rosea Capsule
* Drug: DaZhu Rhodiola Rosea Simulation Capsule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DaZhu Rhodiola Rosea Capsule<br> | Drug: DaZhu Rhodiola Rosea Capsule<br>* Oral administration, 4 capsules, 3 times a day, for 8 weeks<br>|
| Placebo Comparator: DaZhu Rhodiola Rosea Simulation Capsule<br> | Drug: DaZhu Rhodiola Rosea Simulation Capsule<br>* Oral administration, 4 capsules, 3 times a day, for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seattle Angina Questionnaire (SAQ) angina frequency | Scored from 0 to 100, with higher scores indicating better health status | week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SAQ angina stability | Scored from 0 to 100, with higher scores indicating better health status | week 8 | 
| SAQ physical limitation | Scored from 0 to 100, with higher scores indicating better health status | week 8 | 
| SAQ treatment satisfaction | Scored from 0 to 100, with higher scores indicating better health status | week 8 | 
| SAQ disease perception | Scored from 0 to 100, with higher scores indicating better health status | week 8 | 
| Walking distance by 6-minute walking test |  | week 8 | 
| Frequency of angina |  | week 8 | 
| visual analogue scale (VAS) score | Scored from 0 to 10, with higher scores indicating worse health status | week 8 | 
| 36-item Short Form Health Survey (SF-36) score | Scored from 36 to 180, with higher scores indicating better health status | week 8 |