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

NCT01453582 | Completed Phase 3

• 1 other identifier: FJ2011-1.1
• Study Type: interventional
• Target: 478
• Locations: 1 country
• Sites: 13

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

Keywords

Chest stuffiness of TCM; Qi deficiency and blood stasis of TCM

Outcome Measures

Primary Outcomes (1)

• Improvement of total exercise time of treadmill exercise test

  -2 week, 0 weeks, 12 weeks

Secondary Outcomes (10)

• The marked effective rate of angina pectoris

  -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

  -2 weeks, 0 week, 6 weeks, 12 weeks

Study Arms (2)

Propolis

EXPERIMENTAL

Total Flavonoids of Propolis dropping pill

Drug: Total Flavonoids of Propolis dropping pill

Placebo

PLACEBO COMPARATOR

Simulant of total Flavonoids of Propolis dropping pill

Drug: total Flavonoids of Propolis dropping pill

Interventions

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.

Propolis

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Greenvalley Pharmaceutical Co., Ltd.: lead

Study Sites (13)

Guangdong Second Provincial Traditional Chinese Medicine Hospital

Guangzhou, Guangdong, 510095, China

Location

Ruikang Hospital of Guangxi Traditional Chinese Medical University

Nanning, Guangxi, 530011, China

Location

Hubei Hospital of Traditional Chinese Medicine

Wuhan, Hubei, 430060, China

Location

The Affiliated Hospital to Changchun University of Chinese Medicine

Changchun, Jilin, 130021, China

Location

Sencond Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Shenyang, Liaoning, 110086, China

Location

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Shenyang, Liaoning, 110101, China

Location

Neimenggu Hospital of Traditional Chinese and Mongolian Medicine

Hohhot, Neimenggu, 010020, China

Location

Shanghai Hospital of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200071, China

Location

Shuguang Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 201203, China

Location

Shanxi Hospital of Traditional Chinese Medicine

Taiyuan, Shanxi, 030012, China

Location

Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, 300150, China

Location

First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, 300193, China

Location

Xinjiang Hospital of Traditional Chinese Medicine

Ürümqi, Xinjiang, 830000, China

Location

MeSH Terms

Conditions

Angina, Stable

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lanjun Sun

  Sencond Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2011
• First Posted: October 18, 2011
• Study Start: December 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: September 1, 2015
• Last Updated: February 7, 2018

Record last verified: 2017-12

Locations

CN (13)