Coronary Artery Disease
Conditions
Brief summary
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.
Interventions
DRUGDaZhu Rhodiola Rosea Capsule
Oral administration, 4 capsules, 3 times a day, for 8 weeks
DRUGDaZhu Rhodiola Rosea Simulation Capsule
Oral administration, 4 capsules, 3 times a day, for 8 weeks
Sponsors
Jiangsu Kangyuan Pharmaceutical Co. Ltd
Beijing Anzhen Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seattle Angina Questionnaire (SAQ) angina frequency | week 8 | Scored from 0 to 100, with higher scores indicating better health status |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SAQ physical limitation | week 8 | Scored from 0 to 100, with higher scores indicating better health status |
| SAQ treatment satisfaction | week 8 | Scored from 0 to 100, with higher scores indicating better health status |
| SAQ disease perception | week 8 | Scored from 0 to 100, with higher scores indicating better health status |
| SAQ angina stability | week 8 | Scored from 0 to 100, with higher scores indicating better health status |
| Frequency of angina | week 8 | — |
| visual analogue scale (VAS) score | week 8 | Scored from 0 to 10, with higher scores indicating worse health status |
| 36-item Short Form Health Survey (SF-36) score | week 8 | Scored from 36 to 180, with higher scores indicating better health status |
| Walking distance by 6-minute walking test | week 8 | — |
Countries
China
Contacts
Primary ContactShao-Ping Nie, MD, PhD
Backup ContactXiao Wang, MD
Outcome results
None listed