Coronary Artery Disease(CAD)
Conditions
Keywords
coronary artery disease, revascularization, Shexiang Baoxin Pill
Brief summary
The purpose of this study is to determine whether Shexiang Baoxin Pill is effective in the treatment of coronary artery disease not amenable to revascularization on the basis of western medicine therapy.
Detailed description
The western medicine treatment for CAD not amenable to revascularization is limited. Shexiang Baoxin Pill, a kind of Chinese patent medicine has been used for treating coronary artery disease in clinical practice in China for many years. Shexiang baoxin pill(SBP) is applicable to Qi deficiency and blood stasis syndrome in traditional Chinese medicine. Recent experimental research has indicated that SBP can improve myocardial ischemia and promote therapeutic angiogenesis.
Interventions
Conventional western medicine & shexiang baoxin pill
DRUGSBP placebo
Conventional western medicine & placebo (for shexiang baoxin pill)
100mg tablet, one tablet daily.
one tablet daily. (for patients who can't use aspirin)
DRUGAtorvastatin Calcium
10 mg tablet, two tablets each night.
1 tablet two times daily.
12.5 mg or 25 mg two times daily.
20 mg tablet, one tablet three times daily.
Sponsors
Shanghai Hutchison Pharmaceuticals Limited
Jun Li
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Participants are aged between 45 and 75 years, diagnosed with sever CAD through coronary arteriography which shows that the left main coronary artery and three-vessel have sever diffuse stenosis, calcification or vascular ectasia, be in accordance with Traditional Chinese Medicine syndrome of Qi deficiency and blood stasis syndrome or phlegm and stasis mu-tual obstruction syndrome.
Exclusion criteria
* Patients with severe valvular disease, congenital cardiomyopathy decompensation * Patients with CAD complicated with severe multiple organ disease such as severe heart failure, severe lung, liver or renal dysfunction, peptic ulcer in active stage, or intracranial hemorrhage * Patients that use high-dose steroids due to connective tissue disease * Patients with serious infections * Patients with malignant tumor * Patients with hematopoietic diseases * Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | Six months after randomisation | Death caused by cardiovascular disease |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| B-type natriuretic peptide (BNP) | At baseline (before randomisation), and six months after randomisation. | BNP in pg/mL |
| Hospital readmission rates | At baseline (before randomisation), and six months after randomisation. | Hospital readmission rates due to coronary artery disease during treatment |
| Ejection fraction percentage (EF%) | At baseline (before randomisation), and six months after randomisation. | One of the Echocardiographic parameters |
| E/A ratio | At baseline (before randomisation), and six months after randomisation. | One of the Echocardiographic parameters |
| C-reactive protein (CRP) | At baseline(before randomisation), and six months after randomisation. | CRP in μg/L |
Contacts
Primary ContactJun Li, MD
Backup ContactPanpan Tian
Outcome results
None listed