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

Last updated: February 6, 2018
Sponsor: Shanghai Greenvalley Pharmaceutical Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Cardiac Disease

Heart Disease

Cardiovascular Disease

Treatment

N/A

Clinical Study ID

NCT01453582
FJ2011-1.1
  • Ages 35-70
  • All Genders

Study 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

Inclusion Criteria:

  • Class I, Class II and Class III stable angina pectoris, angina attack more than 3times one week;

  • Qi deficiency and blood stasis syndrome of Traditional Chinese Medicine;

  • In resting electrocardiogram, ST-segment deviation≥0.05mv and/or T-waveinversion≥0.2mv in the leads R-wave is predominant during non-attack period, orST-segment deviation≥0.1mv and/or T-wave inversion≥0.2mv in the leads R-wave ispredominant during angina attack;

  • Total exercise time of treadmill exercise test≥3 minutes.The discontinuance standardshould be reached. And the difference of total exercise time between before and afterrun in period should ≤15%;

  • Other confirmed diagnostic evidence of coronary heart disease, such as definitehistory of old myocardial infarction, or incomplete revascularization one year aftercoronary intervention therapy(residual luminal stenosis≥50%), or coronary angiographyevidence(at least single vessel disease and luminal stenosis≥50%), or nucleinexamination evidence, or computer tomography angiography evidence;

  • Signed the informed consent form.

Exclusion

Exclusion Criteria:

  • Chest pain caused by acute myocardial infarction(AMI), Class IV/serious anginapectoris, psychosis, serious neurosis, climacteric syndrome, hyperthyroidism, CervicalSpondylosis, gallbladder- heart syndrome, gastroesophageal reflux, hiatus hernia,aortic dissection, aortic valve disease;

  • Not well controlled hypertension(systolic pressure≥160mmHg,diastolicpressure≥100mmHg), serious cardiopulmonary insufficiency, serious arrhythmia(rapidatrial 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 Propolisdropping 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.

Study Design

Total Participants: 478
Study Start date:
December 01, 2011
Estimated Completion Date:
September 30, 2015

Connect with a study center

  • Guangdong Second Provincial Traditional Chinese Medicine Hospital

    Guangzhou, Guangdong 510095
    China

    Site Not Available

  • Ruikang Hospital of Guangxi Traditional Chinese Medical University

    Nanning, Guangxi 530011
    China

    Site Not Available

  • Hubei Hospital of Traditional Chinese Medicine

    Wuhan, Hubei 430060
    China

    Site Not Available

  • The Affiliated Hospital to Changchun University of Chinese Medicine

    Changchun, Jilin 130021
    China

    Site Not Available

  • Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

    Shenyang, Liaoning 110101
    China

    Site Not Available

  • Sencond Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

    Shenyang, Liaoning 110086
    China

    Site Not Available

  • Neimenggu Hospital of Traditional Chinese and Mongolian Medicine

    Huhehaote, Neimenggu 010020
    China

    Site Not Available

  • Shanghai Hospital of Traditional Chinese Medicine

    Shanghai, Shanghai 200071
    China

    Site Not Available

  • Shuguang Hospital, Shanghai University of Traditional Chinese Medicine

    Shanghai, Shanghai 201203
    China

    Site Not Available

  • Shanxi Hospital of Traditional Chinese Medicine

    Taiyuan, Shanxi 030012
    China

    Site Not Available

  • First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

    Tianjin, Tianjin 300193
    China

    Site Not Available

  • Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

    Tianjin, Tianjin 300150
    China

    Site Not Available

  • Xinjiang Hospital of Traditional Chinese Medicine

    Wulumuqi, Xinjiang 830000
    China

    Site Not Available

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