chronic stable angina
Conditions
Interventions
Treatment group:Guanxinjing capsule
Control group:placebo+routine care
Sponsors
Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Diagnosis of CHD and provided with exact imaging information ( coronary angiography or computed tomography coronary angiography confirmation of stenosis above 50% of at least one major branch of the coronary artery luminal diameter, or nuclear perfusion scan diagnosed as CAD ). Cardiovascular Society classification of angina II to III; (2) Meet the TCM diagnosis standards of Qi deficiency and blood stasis syndrome; (3) At least 2 months of standardized medication history before enrollment (sustain the same medication, type, usage and amount); (4) Aged between 18–75 years, either male or female; (5) Sign informed consent by participants or surrogates; (6) Understand and voluntary compliance with the research program, accept the study prescribed course and limits, understand the oral scale and diary card.
Exclusion criteria
Exclusion criteria: (1) Uncontrolled hypertension (systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg). Severe cardiopulmonary insufficiency, or severe arrhythmia (rapid atrial fibrillation and flutter, paroxysmal ventricular tachycardia, AV block of degree II or above). Acute myocardial infarction (MI) in the past 2 months, or undergoing coronary revascularization in the past 12 months; (2) Renal insufficiency, male serum creatinine >2.5 mg/ dl (>220 umol/L), female serum creatinine >2.0 mg/ dl (>175 µmol/L). Serious liver disease (alanine transaminase and/or aspartate transaminase values two times higher than the upper reference limit value). Other severe primary disease such as malignant tumor, hematopoietic system disease, and so on; (3) Complicated with the absolute contraindications or relative contraindications of exercise tolerance testing (ETT) (eg, severe aortic stenosis, acute aortic dissection, left main coronary artery stenosis, acute myocarditis, pericarditis); (4) Factors that precluded satisfactory interpretation of the ECG (eg, digoxin therapy, left bundle-branch block, implanted with pacemaker, left ventricular hypertrophy, and electrolyte disturbance); (5) Complicated with a serious bone joint disease or other comorbidities that may interfere with ability to perform required exercise tolerance testing (ETT); (6) Patients planning to undergo coronary revascularization during the study period; (7) Patients easy to allergic, or known to be allergic to ingredients of the study drug; (8) Pregnant or trying to get pregnant or during lactation period; (9) Substance abuse, alcohol and drug dependence in the last two years; (10) Other conditions that may affect the subjects' adherence or lead to safety problems in the study; (11) Participation in other clinical trials within the past 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| total exercise time of exercise tolerance tests;the score of angina symptom integral; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Maximal Estimated Workload (in METS) during exercise tolerance testing.;Changes in time to 1mm ST-segment depression or raise during exercise tolerance testing at the end of the treatment period;Changes in time to onset of angina during exercise tolerance testing at the end of the treatment period;The total score of TCM;The total score of GAD-7; | — |
Countries
China
Contacts
Public ContactZheng Wenke
Tianjin University of Traditional Chinese Medicine
Outcome results
None listed