Status:
COMPLETED
Efficacy and Safety Study of Total Flavonoids of Propolis Dropping Pill to Treat Angina Pectoris
Lead Sponsor:
Shanghai Greenvalley Pharmaceutical Co., Ltd.
Conditions:
Stable Angina Pectoris
Eligibility:
All Genders
35-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to confirm the efficacy and safety of total flavonoids of propolis dropping pill to treat angina pectoris, evaluated by total exercise time of treadmill exercise test.
Eligibility Criteria
Inclusion
- Class I, Class II and Class III stable angina pectoris, angina attack more than 3 times one week;
- Qi deficiency and blood stasis syndrome of Traditional Chinese Medicine;
- In resting electrocardiogram, ST-segment deviation≥0.05mv and/or T-wave inversion≥0.2mv in the leads R-wave is predominant during non-attack period, or ST-segment deviation≥0.1mv and/or T-wave inversion≥0.2mv in the leads R-wave is predominant during angina attack;
- Total exercise time of treadmill exercise test≥3 minutes.The discontinuance standard should be reached. And the difference of total exercise time between before and after run in period should ≤15%;
- Other confirmed diagnostic evidence of coronary heart disease, such as definite history of old myocardial infarction, or incomplete revascularization one year after coronary intervention therapy(residual luminal stenosis≥50%), or coronary angiography evidence(at least single vessel disease and luminal stenosis≥50%), or nuclein examination evidence, or computer tomography angiography evidence;
- Signed the informed consent form.
Exclusion
- Chest pain caused by acute myocardial infarction(AMI), Class IV/serious angina pectoris, psychosis, serious neurosis, climacteric syndrome, hyperthyroidism, Cervical Spondylosis, gallbladder- heart syndrome, gastroesophageal reflux, hiatus hernia, aortic dissection, aortic valve disease;
- Not well controlled hypertension(systolic pressure≥160mmHg，diastolic pressure≥100mmHg), serious cardiopulmonary insufficiency, serious arrhythmia(rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, etc);
- Serious diseases of heart, lung, liver, kidney and blood;
- Allergic constitution or allergic to the components of total Flavonoids of Propolis dropping pill;
- Women during pregnancy or lactation;
- Received any major operation within 4 weeks;
- Have been in other clinical trials within 30 days;
- Using but can not withdraw anti-angina medicine as long acting nitrates;
- Not well controlled hyperglycemia;
- Not fit for this trial judged by investigator.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
478 Patients enrolled
Trial Details
Trial ID
NCT01453582
Start Date
December 1 2011
End Date
September 1 2015
Last Update
February 7 2018
Active Locations (13)
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1
Guangdong Second Provincial Traditional Chinese Medicine Hospital
Guangzhou, Guangdong, China, 510095
2
Ruikang Hospital of Guangxi Traditional Chinese Medical University
Nanning, Guangxi, China, 530011
3
Hubei Hospital of Traditional Chinese Medicine
Wuhan, Hubei, China, 430060
4
The Affiliated Hospital to Changchun University of Chinese Medicine
Changchun, Jilin, China, 130021