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

NCT ID: NCT01453582

Last Updated: 2018-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 478 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2015-09-30

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.

Conditions

Stable Angina Pectoris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Propolis

Total Flavonoids of Propolis dropping pill

Group Type: EXPERIMENTAL

Total Flavonoids of Propolis dropping pill

Intervention Type: DRUG

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

Placebo

Simulant of total Flavonoids of Propolis dropping pill

Group Type: PLACEBO_COMPARATOR

total Flavonoids of Propolis dropping pill

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Greenvalley Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lanjun Sun

Role: PRINCIPAL_INVESTIGATOR

Sencond Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Locations

Guangdong Second Provincial Traditional Chinese Medicine Hospital

Guangzhou, Guangdong, China

Ruikang Hospital of Guangxi Traditional Chinese Medical University

Nanning, Guangxi, China

Hubei Hospital of Traditional Chinese Medicine

Wuhan, Hubei, China

The Affiliated Hospital to Changchun University of Chinese Medicine

Changchun, Jilin, China

Sencond Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Shenyang, Liaoning, China

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Shenyang, Liaoning, China

Neimenggu Hospital of Traditional Chinese and Mongolian Medicine

Hohhot, Neimenggu, China

Shanghai Hospital of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Shuguang Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Shanxi Hospital of Traditional Chinese Medicine

Taiyuan, Shanxi, China

Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, China

First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, China

Xinjiang Hospital of Traditional Chinese Medicine

Ürümqi, Xinjiang, China

Countries

China

Other Identifiers

FJ2011-1.1

Identifier Type: -

Identifier Source: org_study_id