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

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.

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.

Study Overview

• Status: Completed
• Conditions: Stable Angina Pectoris
• Intervention / Treatment: Drug: Total Flavonoids of Propolis dropping pill; Drug: total Flavonoids of Propolis dropping pill

• Study Type: Interventional
• Enrollment (Actual): 478
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510095
      • Guangdong Second Provincial Traditional Chinese Medicine Hospital
  • Guangxi
    • Nanning, Guangxi, China, 530011
      • Ruikang Hospital of Guangxi Traditional Chinese Medical University
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Hubei Hospital of Traditional Chinese Medicine
  • Jilin
    • Changchun, Jilin, China, 130021
      • The Affiliated Hospital To Changchun University of Chinese Medicine
  • Liaoning
    • Shenyang, Liaoning, China, 110086
      • Sencond Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
    • Shenyang, Liaoning, China, 110101
      • Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
  • Neimenggu
    • Huhehaote, Neimenggu, China, 010020
      • Neimenggu Hospital of Traditional Chinese and Mongolian Medicine
  • Shanghai
    • Shanghai, Shanghai, China, 200071
      • Shanghai Hospital of Traditional Chinese Medicine
    • Shanghai, Shanghai, China, 201203
      • Shuguang Hospital, Shanghai University of Traditional Chinese Medicine
  • Shanxi
    • Taiyuan, Shanxi, China, 030012
      • Shanxi Hospital of Traditional Chinese Medicine
  • Tianjin
    • Tianjin, Tianjin, China, 300193
      • First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
    • Tianjin, Tianjin, China, 300150
      • Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
  • Xinjiang
    • Wulumuqi, Xinjiang, China, 830000
      • Xinjiang Hospital of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Shanghai Greenvalley Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Lanjun Sun, Sencond Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: October 13, 2011
• First Submitted That Met QC Criteria: October 17, 2011
• First Posted (Estimate): October 18, 2011

Study Record Updates

• Last Update Posted (Actual): February 7, 2018
• Last Update Submitted That Met QC Criteria: February 6, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Chest stuffiness of TCM; Qi deficiency and blood stasis of TCM
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Angina, Stable; Anti-Infective Agents; Propolis
• Other Study ID Numbers: FJ2011-1.1