Stable Angina PectorisPhase 3NCT01453582
Efficacy and Safety Study of Total Flavonoids of Propolis Dropping Pill to Treat Angina Pectoris
A Phase 3 study testing Total Flavonoids of Propolis dropping pill in people with Stable Angina Pectoris, run by Shanghai Greenvalley Pharmaceutical Co., Ltd. at 13 sites in China.
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. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Stable Angina Pectoris
- What is being tested?
- Total Flavonoids of Propolis dropping pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 478 participants
- Where
- 13 sitesChina
- Study dates
- Dec 2011to Sep 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites
The Affiliated Hospital to Changchun University of Chinese Medicine
Changchun, Jilin, 130021
Guangdong Second Provincial Traditional Chinese Medicine Hospital
Guangzhou, Guangdong, 510095
Neimenggu Hospital of Traditional Chinese and Mongolian Medicine
Hohhot, Neimenggu, 010020
Ruikang Hospital of Guangxi Traditional Chinese Medical University
Nanning, Guangxi, 530011
Shanghai Hospital of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200071
Shuguang Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 201203
Sencond Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning, 110086
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning, 110101
Shanxi Hospital of Traditional Chinese Medicine
Taiyuan, Shanxi, 030012
Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 300150
First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 300193
Xinjiang Hospital of Traditional Chinese Medicine
Ürümqi, Xinjiang, 830000
Hubei Hospital of Traditional Chinese Medicine
Wuhan, Hubei, 430060
About this study
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.
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
- Being tested
- Total Flavonoids of Propolis dropping pill
- Keywords
- Chest stuffiness of TCM, Qi deficiency and blood stasis of TCM
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Flavonoids of Propolis dropping pillDrug
One pack contains 30 pills, weight 33g. One pack each time, three times a day, 14 days a course.
total Flavonoids of Propolis dropping pillDrug
One pack contains 30 pills, weight 33g. One pack each time, three times a day, 14 days a course.
| Study group | Role | What they receive |
|---|---|---|
| Propolis | Experimental | Total Flavonoids of Propolis dropping pill Receives: Drug: Total Flavonoids of Propolis dropping pill |
| Placebo | Placebo comparator | Simulant of total Flavonoids of Propolis dropping pill Receives: Drug: total Flavonoids of Propolis dropping pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of total exercise time of treadmill exercise test
Measured: -2 week, 0 weeks, 12 weeks
Secondary outcomes (10)
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.
Measured: -2 weeks, 0 week, 6 weeks, 12 weeks
Attack times of angina pectoris
Measured: -2 weeks, 0 week, 6 weeks, 12 weeks
Pain degree of angina pectoris
Measured: -2 weeks, 0 week, 12 weeks
Duration of angina pectoris attack
Measured: -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.
Measured: -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%.
Measured: -2 weeks, 0 week, 6 weeks, 12 weeks
Score change of the Seattle Angina Questionnaire (SAQ)
Measured: 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.
Measured: -2 weeks, 0 week, 12 weeks
Improvement of other indexes of treadmill exercise test
metabolic equivalent, blood pressure, oxygen consumption, speed, grade.
Measured: -2 weeks, 0 week, 12 weeks
Time to ST-segment deviation>1mm and positive symptoms appear
Measured: -2 weeks, 0 week, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2011 (estimated)
- Study startDec 2011
- Primary completionJun 2014
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable Angina PectorisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 478 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Greenvalley Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lanjun Sun, Principal investigator, Sencond Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01453582
- Sponsor's protocol ID
- FJ2011-1.1
- Status last verified
- Dec 2017
- First submitted
- 13 Oct 2011
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01453582
- Acronym / sponsor ID
- FJ2011-1.1
- Conditions
- Stable Angina Pectoris
- Keywords
- Chest stuffiness of TCM, Qi deficiency and blood stasis of TCM
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 478 participants (actual)
- Lead sponsor
- Shanghai Greenvalley Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 18 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propolis | Experimental | Drug: Total Flavonoids of Propolis dropping pillTotal Flavonoids of Propolis dropping pill |
| Placebo | Placebo comparator | Drug: total Flavonoids of Propolis dropping pillSimulant of total Flavonoids of Propolis dropping pill |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Flavonoids of Propolis dropping pillOne pack contains 30 pills, weight 33g. One pack each time, three times a day, 14 days a course. | Drug | Propolis |
| total Flavonoids of Propolis dropping pillOne pack contains 30 pills, weight 33g. One pack each time, three times a day, 14 days a course. | Drug | Placebo |
Primary outcome
Improvement of total exercise time of treadmill exercise test
Time frame: -2 week, 0 weeks, 12 weeks
10 secondary outcomes
The marked effective rate of angina pectoris
Time frame: -2 weeks, 0 week, 6 weeks, 12 weeks
Attack times of angina pectoris
Time frame: -2 weeks, 0 week, 6 weeks, 12 weeks
Pain degree of angina pectoris
Time frame: -2 weeks, 0 week, 12 weeks
Duration of angina pectoris attack
Time frame: -2 weeks, 0 week, 6 weeks, 12 weeks
Dose change of nitroglycerin
Time frame: -2 weeks, 0 week, 6 weeks, 12 weeks
The main symptoms of Chinese Traditional Medicine
Time frame: -2 weeks, 0 week, 6 weeks, 12 weeks
Score change of the Seattle Angina Questionnaire (SAQ)
Time frame: 0 week, 12 weeks
Improvement of ECG
Time frame: -2 weeks, 0 week, 12 weeks
Improvement of other indexes of treadmill exercise test
Time frame: -2 weeks, 0 week, 12 weeks
Time to ST-segment deviation>1mm and positive symptoms appear
Time frame: -2 weeks, 0 week, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lanjun Sun principal investigator
Sencond Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Total Flavonoids of Propolis dropping pill in people with Stable Angina Pectoris, run by Shanghai Greenvalley Pharmaceutical Co., Ltd. at 13 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of total exercise time of treadmill exercise test (time frame: -2 week, 0 weeks, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2018.