Coronary Heart Disease
Conditions
Interventions
The test group :Shexiang Tongxin Dropping Pill
The control group :Shexiang Tongxin Dropping Pill placebo
Sponsors
The Second Hospital Affiliated to Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The patients are still have twice or more times mild or moderate anginal attacks a week(CCS grade II or grade III),who accept the treatment of chronic stable coronary artery disease under the current guidelines,or who are taboo or cannot be tolerated to the recommended treatment of the guidelines; 2. The patients meet the TCM differentiation criteria of phlegm-heat and blood stasis syndrome; 3. 18-70 years old; 4. Patients' total exercise duration(TED) are between 3 and 12 minutes using the standard Bruce Protocol;The results of treadmill exercise test are positive; The positive result of treadmill exercise test is defined as that when one of the fllowings occurs: (1) The corresponding leads of R wave dominated on ECG show that ST segment horizontal or drooping down (ischemic) lasting 3 consecutive heart periods at 80ms after the J point,depresses 0.1mv or more than before exercise lasting 2 minutes or more,or ST segment arched elevation >=0.1mv; (2) Patients have typical angina during treadmill exercise test. 5. There are other evidences of diagnosis of coronary artery disease:at least one of the followings: (1) have a clear medical history of old myocardial infarction; (2) have had accepted coronary revascularization(PCI or CABG),but there is still a major coronary artery which is not complete recanalization,stenosis >50%; (3) once coronary angiography or CT angiography shows a major coronary artery stenosis >50%; (4) other evidences of noninvasive examination to support the diagnosis of coronary artery disease (radionuclide stress test?echocardiography stress test, magnetic resonance stress test); 6. Patients informed and sign consent form voluntary.
Exclusion criteria
Exclusion criteria: 1. Acute myocardial infarction in the past three months; 2. The result of coronary angiography suggests the left main coronary artery stenosis >=50%,or the proximal LAD stenosis >=70%,or a triple vessel disease; 3. Resting ECG abnormalities,which affects the judgement of the result of the exercise test;(e.g.,(1)left bundle branch block; (2)the use of digoxin; (3)left ventricular hypertrophy; (4)the preexcitation syndrome); 4. Poorly controlled hypertension.(systolic pressure >=160mmHg or diastolic pressure >=100mmHg); 5. Severe cardiopulmonary dysfunction.(e.g.,cardiac function grade II or above); 6. Severe arrhythmias.(rapid atrial fibrillation,atrial flutter,paroxysmal supraventricular tachycardia,type II second-degree or above atrioventricular block,complete bundle branch block); 7. QT/QTc interval prolongation (QTc interval >450ms), or had a medical history of which may lead to torsades de pointes (e.g.,heart failure,hypokalemia,and familial long QT syndrome, or used drugs which might prolong the QT/QTc interval); 8. ECG ST-T changed,the result of submaximal exercise test was negative,and without an objective evidence of diagnosis of coronary artery disease (e.g.,coronary angiography,positive indicators of cardiac radionuclide scan, and a medical history of old myocardial infarction); 9. Combined with liver,kidney,hematopoietic system and other serious primary diseases,such as: liver function(ALT >=1.5 *ULN, AST >=1.5 *ULN), renal function (Cr>1.5 *ULN), and mentally ill; 10. Pregnant or lactating women; 11. Had surgery in the past 4 weeks and bleeding tendencies; 12. Participated in any other clinical trial in the past one month; 13. Allergy to the known of the composition of the drug; 14. According to the investigator's judgment,what might reduce the likelihood of a patient's participation in the trial(week,etc.); 15. A medical history of gastrointestinal disease or gastrointestinal surgery that might affect the drug absorption; 16. Difficulty in movement, or could not complete enough exercise (due to physical or mental reasons,etc.); 17. The researcher considered patients unsuitable for inclusion because of other cases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total exercise duration;METs; | — |
Secondary
| Measure | Time frame |
|---|---|
| The time of inducing ST-T to depress 0.1mV than before exercise;High-sensitivity C reactive protein;Scores of angina pectoris symptom;Electrocardiogram: ST-T change;Related symptoms and signs: TCM symptoms, heart rate, blood pressure, tongue picture, pulse, rhythm of the heart;Seattle Angina Questionnaire (SAQ); | — |
Countries
China
Contacts
Public ContactYingqiang Zhao
Outcome results
None listed