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

Sponsor

Shanghai Greenvalley Pharmaceutical Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT01453582

Collaborator

(none)

478

Enrollment

Locations

Arms

Duration (Months)

36.8

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stable Angina Pectoris	Drug: Total Flavonoids of Propolis dropping pill Drug: total Flavonoids of Propolis dropping pill	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

478 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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.

Study Start Date :

Dec 1, 2011

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Propolis

Total Flavonoids of Propolis dropping pill

Drug: Total Flavonoids of Propolis dropping pill

One pack contains 30 pills, weight 33g. One pack each time, three times a day, 14 days a course.

Placebo Comparator: Placebo

Simulant of total Flavonoids of Propolis dropping pill

Drug: total Flavonoids of Propolis dropping pill

One pack contains 30 pills, weight 33g. One pack each time, three times a day, 14 days a course.

Outcome Measures

Primary Outcome Measures

Improvement of total exercise time of treadmill exercise test [-2 week, 0 weeks, 12 weeks]

Secondary Outcome Measures

The marked effective rate of angina pectoris [-2 weeks, 0 week, 6 weeks, 12 weeks]
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.
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 [-2 weeks, 0 week, 6 weeks, 12 weeks]
Withdraw: completely withdrawal after the treatment; Decrease: decrement ≥50% after the treatment; No change: decrement <50% after the treatment.
The main symptoms of Chinese Traditional Medicine [-2 weeks, 0 week, 6 weeks, 12 weeks]
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%.
Score change of the Seattle Angina Questionnaire (SAQ) [0 week, 12 weeks]
Improvement of ECG [-2 weeks, 0 week, 12 weeks]
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.
Improvement of other indexes of treadmill exercise test [-2 weeks, 0 week, 12 weeks]
metabolic equivalent, blood pressure, oxygen consumption, speed, grade.
Time to ST-segment deviation>1mm and positive symptoms appear [-2 weeks, 0 week, 12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Sencond Affiliated Hospital of Liaoning University of Traditional Chinese Medicine	Shenyang	Liaoning	China	110086
6	Affiliated Hospital of Liaoning University of Traditional Chinese Medicine	Shenyang	Liaoning	China	110101
7	Neimenggu Hospital of Traditional Chinese and Mongolian Medicine	Huhehaote	Neimenggu	China	010020
8	Shanghai Hospital of Traditional Chinese Medicine	Shanghai	Shanghai	China	200071
9	Shuguang Hospital, Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai	China	201203
10	Shanxi Hospital of Traditional Chinese Medicine	Taiyuan	Shanxi	China	030012
11	Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine	Tianjin	Tianjin	China	300150
12	First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine	Tianjin	Tianjin	China	300193
13	Xinjiang Hospital of Traditional Chinese Medicine	Wulumuqi	Xinjiang	China	830000