Efficacy and Safety Study of Total Flavonoids of Propolis Dropping Pill to Treat Angina Pectoris

Green Valley Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Stable Angina Pectoris

Treatments

Drug: total Flavonoids of Propolis dropping pill

Drug: Total Flavonoids of Propolis dropping pill

Study type

Interventional

Funder types

Industry

Identifiers

NCT01453582

FJ2011-1.1

Details and patient eligibility

About

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.

Enrollment

478 patients

Sex

All

Ages

35 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.