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NCT Number: NCT01453582

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

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.

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Key information

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Guangdong Second Provincial Traditional Chinese Medicine Hospital, Guangzhou, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Total Flavonoids of Propolis dropping pill

Drug

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

Primary outcomes

  1. Improvement of total exercise time of treadmill exercise test

    Time frame: -2 week, 0 weeks, 12 weeks

Secondary outcomes

  1. The marked effective rate of angina pectoris

    Time frame: -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.
  2. Attack times of angina pectoris

    Time frame: -2 weeks, 0 week, 6 weeks, 12 weeks

  3. Pain degree of angina pectoris

    Time frame: -2 weeks, 0 week, 12 weeks

  4. Duration of angina pectoris attack

    Time frame: -2 weeks, 0 week, 6 weeks, 12 weeks

  5. Dose change of nitroglycerin

    Time frame: -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.
  6. The main symptoms of Chinese Traditional Medicine

    Time frame: -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%.
  7. Score change of the Seattle Angina Questionnaire (SAQ)

    Time frame: 0 week, 12 weeks

  8. Improvement of ECG

    Time frame: -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.
  9. Improvement of other indexes of treadmill exercise test

    Time frame: -2 weeks, 0 week, 12 weeks

    metabolic equivalent, blood pressure, oxygen consumption, speed, grade.

  10. Time to ST-segment deviation>1mm and positive symptoms appear

    Time frame: -2 weeks, 0 week, 12 weeks

Sponsors and collaborators

Lead sponsor

Shanghai Greenvalley Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Oct 18, 2011
Registry last updated
Feb 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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