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

Study Overview
=================
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.

Official Title
-----------------
Phase III Study of Total Flavonoids of Propolis Dropping Pill in Angina Pectoris: A Randomized, Double-Blind, Placebo-Controlled Multi-Centered Clinical Trial on Efficacy and Safety.

Conditions
-----------------
Stable Angina Pectoris

Intervention / Treatment
-----------------
* Drug: Total Flavonoids of Propolis dropping pill
* Drug: total Flavonoids of Propolis dropping pill


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propolis<br>Total Flavonoids of Propolis dropping pill | Drug: Total Flavonoids of Propolis dropping pill<br>* One pack contains 30 pills, weight 33g. One pack each time, three times a day, 14 days a course.<br>|
| Placebo Comparator: Placebo<br>Simulant of total Flavonoids of Propolis dropping pill | Drug: total Flavonoids of Propolis dropping pill<br>* One pack contains 30 pills, weight 33g. One pack each time, three times a day, 14 days a course.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of total exercise time of treadmill exercise test |  | -2 week, 0 weeks, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The marked effective rate of angina pectoris | Class I: No symptom or almost no symptom, decrease of angina pectoris total score ≥ 1/3； Class II: No symptom or almost no symptom, decrease of angina pectoris total score ≥ 2/3； Class III: Almost no symptom, decrease of angina pectoris total score ≥ 2/3, or the score decrease to the degree of Slight or Class I. | -2 weeks, 0 week, 6 weeks, 12 weeks | 
| Attack times of angina pectoris |  | -2 weeks, 0 week, 6 weeks, 12 weeks | 
| Pain degree of angina pectoris |  | -2 weeks, 0 week, 12 weeks | 
| Duration of angina pectoris attack |  | -2 weeks, 0 week, 6 weeks, 12 weeks | 
| Dose change of nitroglycerin | Withdraw: completely withdrawal after the treatment; Decrease: decrement ≥50% after the treatment; No change: decrement <50% after the treatment. | -2 weeks, 0 week, 6 weeks, 12 weeks | 
| The main symptoms of Chinese Traditional Medicine | Effect index = (total score before treatment - total score after treatment)/total score before treatment×100% Cured: effect index ≥90%; Marked effective: 90%> effect index ≥70%; Effective: 70%> effect index ≥30%; Ineffective: effect index <30%. | -2 weeks, 0 week, 6 weeks, 12 weeks | 
| Score change of the Seattle Angina Questionnaire (SAQ) |  | 0 week, 12 weeks | 
| Improvement of ECG | Cured: normal or almost normal; Marked effective: ST-segment deviation upturn≥0.05mV, but still abnormal, improvement of T-wave inversion of main leads ≥25%, or flate T-wave change to vertical, improved atrioventricular block or intraventricular block; Effective: almost no charge; Ineffective: anabatic ST-segment deviation, deeper T-wave, or flate T-wave change to inverted. | -2 weeks, 0 week, 12 weeks | 
| Improvement of other indexes of treadmill exercise test | metabolic equivalent, blood pressure, oxygen consumption, speed, grade. | -2 weeks, 0 week, 12 weeks | 
| Time to ST-segment deviation>1mm and positive symptoms appear |  | -2 weeks, 0 week, 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chest stuffiness of TCM, Qi deficiency and blood stasis of TCM