Back to resultsEfficacy and Safety Study of Total Flavonoids of Propolis Dropping Pill to Treat Angina Pectoris
Primary Purpose
Stable Angina Pectoris
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Total Flavonoids of Propolis dropping pill
total Flavonoids of Propolis dropping pill
Sponsored by
About this trial
This is an interventional treatment trial for Stable Angina Pectoris focused on measuring Chest stuffiness of TCM, Qi deficiency and blood stasis of TCM
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.
Sites / Locations
- Guangdong Second Provincial Traditional Chinese Medicine Hospital
- Ruikang Hospital of Guangxi Traditional Chinese Medical University
- Hubei Hospital of Traditional Chinese Medicine
- The Affiliated Hospital to Changchun University of Chinese Medicine
- Sencond Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
- Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
- Neimenggu Hospital of Traditional Chinese and Mongolian Medicine
- Shanghai Hospital of Traditional Chinese Medicine
- Shuguang Hospital, Shanghai University of Traditional Chinese Medicine
- Shanxi Hospital of Traditional Chinese Medicine
- Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
- First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
- Xinjiang Hospital of Traditional Chinese Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Propolis
Placebo
Arm Description
Total Flavonoids of Propolis dropping pill
Simulant of total Flavonoids of Propolis dropping pill
Outcomes
Primary Outcome Measures
Improvement of total exercise time of treadmill exercise test
Secondary Outcome Measures
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.
Attack times of angina pectoris
Pain degree of angina pectoris
Duration of angina pectoris attack
Dose change of nitroglycerin
Withdraw: completely withdrawal after the treatment;
Decrease: decrement ≥50% after the treatment;
No change: decrement <50% after the treatment.
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%.
Score change of the Seattle Angina Questionnaire (SAQ)
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.
Improvement of other indexes of treadmill exercise test
metabolic equivalent, blood pressure, oxygen consumption, speed, grade.
Time to ST-segment deviation>1mm and positive symptoms appear
Full Information
NCT ID
NCT01453582
First Posted
October 13, 2011
Last Updated
February 6, 2018
Sponsor
Shanghai Greenvalley Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01453582
Brief Title
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
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Greenvalley Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Angina Pectoris
Keywords
Chest stuffiness of TCM, Qi deficiency and blood stasis of TCM
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
478 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Propolis
Arm Type
Experimental
Arm Description
Total Flavonoids of Propolis dropping pill
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Simulant of total Flavonoids of Propolis dropping pill
Intervention Type
Drug
Intervention Name(s)
Total Flavonoids of Propolis dropping pill
Intervention Description
One pack contains 30 pills, weight 33g. One pack each time, three times a day, 14 days a course.
Intervention Type
Drug
Intervention Name(s)
total Flavonoids of Propolis dropping pill
Intervention Description
One pack contains 30 pills, weight 33g. One pack each time, three times a day, 14 days a course.
Primary Outcome Measure Information:
Title
Improvement of total exercise time of treadmill exercise test
Time Frame
-2 week, 0 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
The marked effective rate of angina pectoris
Description
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.
Time Frame
-2 weeks, 0 week, 6 weeks, 12 weeks
Title
Attack times of angina pectoris
Time Frame
-2 weeks, 0 week, 6 weeks, 12 weeks
Title
Pain degree of angina pectoris
Time Frame
-2 weeks, 0 week, 12 weeks
Title
Duration of angina pectoris attack
Time Frame
-2 weeks, 0 week, 6 weeks, 12 weeks
Title
Dose change of nitroglycerin
Description
Withdraw: completely withdrawal after the treatment;
Decrease: decrement ≥50% after the treatment;
No change: decrement <50% after the treatment.
Time Frame
-2 weeks, 0 week, 6 weeks, 12 weeks
Title
The main symptoms of Chinese Traditional Medicine
Description
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%.
Time Frame
-2 weeks, 0 week, 6 weeks, 12 weeks
Title
Score change of the Seattle Angina Questionnaire (SAQ)
Time Frame
0 week, 12 weeks
Title
Improvement of ECG
Description
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.
Time Frame
-2 weeks, 0 week, 12 weeks
Title
Improvement of other indexes of treadmill exercise test
Description
metabolic equivalent, blood pressure, oxygen consumption, speed, grade.
Time Frame
-2 weeks, 0 week, 12 weeks
Title
Time to ST-segment deviation>1mm and positive symptoms appear
Time Frame
-2 weeks, 0 week, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lanjun Sun
Organizational Affiliation
Sencond Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong Second Provincial Traditional Chinese Medicine Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510095
Country
China
Facility Name
Ruikang Hospital of Guangxi Traditional Chinese Medical University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530011
Country
China
Facility Name
Hubei Hospital of Traditional Chinese Medicine
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Facility Name
The Affiliated Hospital to Changchun University of Chinese Medicine
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Sencond Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110086
Country
China
Facility Name
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110101
Country
China
Facility Name
Neimenggu Hospital of Traditional Chinese and Mongolian Medicine
City
Huhehaote
State/Province
Neimenggu
ZIP/Postal Code
010020
Country
China
Facility Name
Shanghai Hospital of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200071
Country
China
Facility Name
Shuguang Hospital, Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201203
Country
China
Facility Name
Shanxi Hospital of Traditional Chinese Medicine
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030012
Country
China
Facility Name
Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300150
Country
China
Facility Name
First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300193
Country
China
Facility Name
Xinjiang Hospital of Traditional Chinese Medicine
City
Wulumuqi
State/Province
Xinjiang
ZIP/Postal Code
830000
Country
China
12. IPD Sharing Statement
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Efficacy and Safety Study of Total Flavonoids of Propolis Dropping Pill to Treat Angina Pectoris
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