Stable Angina of Coronary Heart Disease
Conditions
Interventions
Experimental group:Xuefu Zhuyu Oral Liquids
Control group:Placebo
Sponsors
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Inclusion criteria of RCT: (1) Meeting the diagnostic criteria of stable angina of coronary heart disease, and diagnosed as qi stagnation and blood stasis in Chinese medicine. (2) Aged between 35 and 80 years. (3) Male with any following conditions and female fulfilling (2), (3), (4), or (5). 1) Positive second quantity Exercise Treadmill Testing. 2) Positive randionuclide exercise test. 3) Had suffered from myocardial infarction for more than 3 months. 4) Had undergone Percutaneous coronary intervention (PCI) for more than 12 months. 5) Presentation of a stenosis >= 50% in at least one main coronary artery or its larger. branches in either coronary angiography or coronary CTA. (4) Canadian Cardiovascular Society (CCS) angina severity class ranging from I to III. (5) The frequency of angina attack >= 2 weekly and = 3cm in the past 2 week. (7) Signature of Informed consent document. 2.Inclusion criteria of observational study: (1) Meeting the diagnostic criteria of stable angina of coronary heart disease, and diagnosed as non qi stagnation and blood stasis in Chinese medicine. (2) Aged between 35 and 80 years. (3) Male with any following conditions and female fulfilling (2), (3), (4), or (5). 1) Positive second quantity Exercise Treadmill Testing. 2) Positive randionuclide exercise test. 3) Had suffered from myocardial infarction for more than 3 months. 4) Had undergone Percutaneous coronary intervention (PCI) for more than 12 months. 5) Presentation of a stenosis >= 50% in at least one main coronary artery or its larger. branches in either coronary angiography or coronary CTA. (4) Canadian Cardiovascular Society (CCS) angina severity class ranging from I to III. (5) The frequency of angina attack >= 2 weekly and = 3cm in the past 2 week. (7) Signature of Informed consent document.
Exclusion criteria
Exclusion criteria: 1. Exclusion criteria of RCT: (1) Suffering from severe heart disease including: unstable angina, severe arrhythmias (rapid atrial fibrillation, Atrial flutter, paroxysmal ventricular tachycardia, Mobitz II second degree atrioventricular (AV) block, third degree AV block, etc), severe cardiopulmonary insufficiency (cardiac function grade IV, severely abnormal pulmonary function). (2) Hypertension poorly controlled (systolic blood pressure(SBP) >= 160mmHg or diastolic blood pressure(DBP) >= 100mmHg after treatment). (3) Plan to undergo Coronary artery bypass grafting(CABG) or PCI during the trial. (4) Complicated with disease triggering chest pain, such as other heart disease, neurosis, menopausal syndrome, Spondylotic disease, gastroesophageal reflux disease (GERD). (5) Complicated with severe liver and renal dysfunction(value of ALT, AST and TBIL more than 1.5 times the upper limit of normal reference, value of Cr more than the upper limit of normal reference). (6) Combined with severe primary disease, such as respiratory, digestive sysetm, urinary, hemopoietic system, specially including chronic obstructive pulmonary disease (COPD), severe gastrointestinal ulcer, aplastic anemia, diabetes mellitus (DM), and tumor. (7) Zung's Self-Rating Anxiety Scale(Zung-SAS) > 59, or Zung's Self-rating Depression Scale(Zung-SDS)> 62. (8) Woman with pregnancy, lactation or of child bearing potential plan to conceive. (9) Failing to cooperate with investigator to participate in the trial(including blindness, deafness, dumbness, intellectual disability, mental disability, and so on). (10) Participating in other clinical trials within the last 3 months. (11) Allergic constitution or hypersensitivity to the known component of the study drug. (12) Not suitable for the study as judged by investigator. 2. Exclusion criteria of observational study: (1) Woman with pregnancy, lactation or of child bearing potential plan to conceive. (2) Allergic constitution or hypersensitivity to the known component of the study drug. (3) Participating in other clinical trials within the last 3 months. (4) Not suitable for the study as judged by investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline angina pain intensity evaluated with VAS at 12 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| The frequency of angina attack;Duration of angina attack;The dosage of nitroglycerin;CCS angina severity class;Seattle Angina Questionnaire (SAQ);Table collected chinese medicine(TCM) symptom, tongue manifestation and pulse condition;EuroQol-5-Dimensions-5-Level (EQ-5D-5L);Incidence of Major adverse cardiac events (MACEs), including rehospitalization and coronary revascularization(PCI and CABG) due to angina.;Economic evaluation;Overall assessment of drug; | — |
Countries
China
Contacts
Public ContactZehuai Wen
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed