Coronary heart disease and angina pectoris
Conditions
Interventions
The test group:Xin Shu Capsule + Xinkeshu capsul placebo
The control group:Xin Ke Shu Capsule
Sponsors
Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Meeting diagnostic criteria of angina pectoris in Western medicine; stable exertional angina pectoris (grade ?, II, and III) which occurs for more than 2 times a week; 2. Patients with syndrome of qi and blood stasis in TCM; 3. Patients with one of the followings: (1) Patients with angina pectoris diagnosed by one of the following means: coronary angiography, CTA, electrocardiogram on exercise test, and isotope detection diagnosis; (2) Patients with positive results of ECG on exercise test at the time of their grouping (of which, males just have positive results and females not only have positive results but also meeting (1) or (3); (3) Patients with a history of myocardial infarction for 3 months or more; 4. Patient's total exercise duration (TED) of 3-12 minutes under improved Bruce Protocol; 5.Patients between 35 to 70 years old (including the age of 35 and 70 years) (patients between 18 to 35 years old can be included if they meet 3 (1) or (3)); 6. Patients who do not take drugs, or stop the use of Western Medicine drugs (banned drugs in drug combination) for more than 5 half-lives and stop the use of TCM drugs for 2 weeks or more (except nitroglycerin); 7. Patients who sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed with acute myocardial infarction and other heart disease, severe neurosis, menopausal syndrome, cervical spondylosis, chest pain of esophageal or gallbladder origin and so forth which are considered by researchers to affect clinical evaluation; 2. Patients with still high blood pressure after concurrent hypertension treated via drugs (systolic pressure =160mmHg or diastolic blood pressure =100mmHg), severe cardiopulmonary insufficiency, severe arrhythmia (rapid atrial fibrillation or flutter, paroxysmal ventricular tachycardia, ?, ? and ? degree atrioventricular block, and etc.); 3. Patients with concurrent serious primary diseases in liver, kidney, hematopoietic system, and so forth and patients with mental disorders, of which blood ALT, AST > 1.5 times normal limit and serum creatinine (Cr) > normal limit; 4. Patients with severe cerebrovascular disease, coronary syndrome, unstable angina pectoris, congestive heart failure, acute myocarditis or pericarditis, thrombophlebitis or pulmonary embolism, or patients with a history of myocardial infarction within 3 months; 5. Patients who have a history of bleeding or are taking warfarin. 6. Patients who implant a pacemaker or receive PCI or whose condition is not stable or affect the clinical evaluation in the researchers opinion; 7. Pregnancy or lactation women, and patients with allergic constitution; 8. Patients with disability (blind, deaf, dumb, mental retardation, mental disorder or physical disability); 9. Patients who participate in other clinical trials within 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness evaluation indicators (1) Angina symptom integral (2) Plate exercise test indicators (total exercise duration and Duke score) (50% of cases subject ot plate exercise test) (3) Improvement of individual symptoms (insomnia, upset, anxiety, depression, preference for sigh) (4) TCM syndrome efficacy score (5) Nitroglycerin withdrawal or reduction rate (6) ECG effect (7) Seattle angina questionnaire (SAQ).; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation indicators (1) Possible adverse reactions, and incidence of adverse reactions (2) General P.E. items, such as body temperature, heart rate, respiration, blood pressure, etc. (3) Blood routine, urine routine, and stool routine, electrocardiogram (QT interval), liver function (ALT, AST, r - GT, Tbil, ALP), kidney function (BUN, Cr), blood coagulation (TT, APTT, PT, FIB).; | — |
Countries
China
Contacts
Public ContactWang Xian
Dongzhimen Hospital, Beijing University of Traditional Chinese Medicine
Outcome results
None listed