Clinical trial NCT01453582: Efficacy and Safety Study of Total Flavonoids of Propolis Dropping Pill to Treat Angina Pectoris
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stable Angina Pectoris
Keywords: Chest stuffiness of TCM
Qi deficiency and blood stasis of TCM
Lead sponsor: Shanghai Greenvalley Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-10-18
Enrollment: 478
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Improvement of total exercise time of treadmill exercise test
timeFrame: -2 week, 0 weeks, 12 weeks
Secondary outcomes:
measure: The marked effective rate of angina pectoris
timeFrame: -2 weeks, 0 week, 6 weeks, 12 weeks
measure: Attack times of angina pectoris
timeFrame: -2 weeks, 0 week, 6 weeks, 12 weeks
measure: Pain degree of angina pectoris
timeFrame: -2 weeks, 0 week, 12 weeks
measure: Duration of angina pectoris attack
timeFrame: -2 weeks, 0 week, 6 weeks, 12 weeks
measure: Dose change of nitroglycerin
timeFrame: -2 weeks, 0 week, 6 weeks, 12 weeks
measure: The main symptoms of Chinese Traditional Medicine
timeFrame: -2 weeks, 0 week, 6 weeks, 12 weeks
measure: Score change of the Seattle Angina Questionnaire (SAQ)
timeFrame: 0 week, 12 weeks
measure: Improvement of ECG
timeFrame: -2 weeks, 0 week, 12 weeks
measure: Improvement of other indexes of treadmill exercise test
timeFrame: -2 weeks, 0 week, 12 weeks
measure: Time to ST-segment deviation>1mm and positive symptoms appear
timeFrame: -2 weeks, 0 week, 12 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Second Provincial Traditional Chinese Medicine Hospital
state: Guangdong
city: Nanning
country: China
facility: Ruikang Hospital of Guangxi Traditional Chinese Medical University
state: Guangxi
city: Wuhan
country: China
facility: Hubei Hospital of Traditional Chinese Medicine
state: Hubei
city: Changchun
country: China
facility: The Affiliated Hospital to Changchun University of Chinese Medicine
state: Jilin
city: Shenyang
country: China
facility: Sencond Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
state: Liaoning
city: Shenyang
country: China
facility: Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
state: Liaoning
city: Huhehaote
country: China
facility: Neimenggu Hospital of Traditional Chinese and Mongolian Medicine
state: Neimenggu
city: Shanghai
country: China
facility: Shanghai Hospital of Traditional Chinese Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shuguang Hospital, Shanghai University of Traditional Chinese Medicine
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Hospital of Traditional Chinese Medicine
state: Shanxi
city: Tianjin
country: China
facility: Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
state: Tianjin
city: Tianjin
country: China
facility: First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
state: Tianjin
city: Wulumuqi
country: China
facility: Xinjiang Hospital of Traditional Chinese Medicine
state: Xinjiang
Study officials:
affiliation: Sencond Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
name: Lanjun Sun
role: PRINCIPAL_INVESTIGATOR
References: