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

Stable Angina Pectoris Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01453582
• Other study ID #: FJ2011-1.1
• Status: Completed
• Phase: Phase 3
• First received: October 13, 2011
• Last updated: February 6, 2018
• Start date: December 2011
• Est. completion date: September 2015

Study information

• Verified date: December 2017
• Source: Shanghai Greenvalley Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 478
• Est. completion date: September 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Stable Angina Pectoris

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	The Affiliated Hospital to Changchun University of Chinese Medicine	Changchun	Jilin
China	Guangdong Second Provincial Traditional Chinese Medicine Hospital	Guangzhou	Guangdong
China	Neimenggu Hospital of Traditional Chinese and Mongolian Medicine	Huhehaote	Neimenggu
China	Ruikang Hospital of Guangxi Traditional Chinese Medical University	Nanning	Guangxi
China	Shanghai Hospital of Traditional Chinese Medicine	Shanghai	Shanghai
China	Shuguang Hospital, Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai
China	Affiliated Hospital of Liaoning University of Traditional Chinese Medicine	Shenyang	Liaoning
China	Sencond Affiliated Hospital of Liaoning University of Traditional Chinese Medicine	Shenyang	Liaoning
China	Shanxi Hospital of Traditional Chinese Medicine	Taiyuan	Shanxi
China	First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine	Tianjin	Tianjin
China	Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine	Tianjin	Tianjin
China	Hubei Hospital of Traditional Chinese Medicine	Wuhan	Hubei
China	Xinjiang Hospital of Traditional Chinese Medicine	Wulumuqi	Xinjiang

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Greenvalley Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of total exercise time of treadmill exercise test		-2 week, 0 weeks, 12 weeks
Secondary	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
Secondary	Attack times of angina pectoris		-2 weeks, 0 week, 6 weeks, 12 weeks
Secondary	Pain degree of angina pectoris		-2 weeks, 0 week, 12 weeks
Secondary	Duration of angina pectoris attack		-2 weeks, 0 week, 6 weeks, 12 weeks
Secondary	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
Secondary	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
Secondary	Score change of the Seattle Angina Questionnaire (SAQ)		0 week, 12 weeks
Secondary	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
Secondary	Improvement of other indexes of treadmill exercise test	metabolic equivalent, blood pressure, oxygen consumption, speed, grade.	-2 weeks, 0 week, 12 weeks
Secondary	Time to ST-segment deviation>1mm and positive symptoms appear		-2 weeks, 0 week, 12 weeks