Unstable angina
Conditions
Interventions
Test group:Shen’e Xiaozheng Formula, twice a day, one bag in the morning and one bag in the evening, taken with water, and the course of treatment is 4 weeks.
Control gruop:Placebo, twice a day, one bag in the morning and one bag in the evening, taken with water, and the course of treatment is 4 weeks.
Sponsors
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Those who meet the diagnostic criteria of unstable angina pectoris and deficiency-blood stasis-toxicity pattern; (2) Patients with Braunwald angina grade ?-? and GRACE risk stratiography were classified into low-risk and intermediate-risk patients (GRACE score less than 140); (3) Those aged between 18 and 80 years; (4) Patients were informed of the study content and voluntarily signed the informed consent.
Exclusion criteria
Exclusion criteria: (1) Infection, fever, trauma, burn, surgical history, serious blood system disease, malignant tumor and serious mental illness within the past 1 month; (2) Patients who have undergone revascularization (PCI or coronary artery bypass grafting) within the past three months or are scheduled to undergo revascularization in the near future; (3) valvular heart disease (moderate lesions of one or more valves) or primary cardiomyopathy; (4) Poor control of hypertension (systolic blood pressure =160mmHg, or diastolic blood pressure =100mmHg), severe cardiac insufficiency (cardiac function grade III or ?), serious arrhythmia, the use of cardiac pacemakers; In acute stage of cerebral infarction, glutamic pyruvic transaminase and (or) glutamic oxalacetic transaminase = 2 times the upper limit of normal, creatinine = 1.5 times the upper limit of normal; (5) Other causes affecting the change of ST-T in ECG were excluded, such as myocardial hypertrophy, left bundle branch block, digitalis drug influence, electrolyte disturbance, etc. (6) Exclude aortic dissection, other congenital heart disease, severe neurosis, menopausal syndrome, hyperthyroidism, cervical spondylosis, stomach and esophageal reflux and other chest pain caused by non-coronary artery disease; Patients with myocardial infarction and preinfarction symptoms in the three months prior to the trial. Unstable angina pectoris should be especially distinguished from the early symptoms of myocardial infarction. (7) Patients with acute exacerbation of chronic obstructive pulmonary disease or pulmonary heart disease or respiratory failure; (8) Patients with autoimmune diseases or with drugs that inhibit inflammatory response (such as non-steroidal anti-inflammatory drugs and steroids); (9) Prepare pregnant men and women, lactating women and pregnant women; (10) Suspected allergy to the investigational drug or any of its ingredients; (11) Participants in other clinical trials within 3 months; (12) A history of drug abuse; (13) Poor compliance and other patients not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Curative effect of angina pectoris symptoms (total effective rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| Nitroglycerin consumption;Duration of angina;Weekly frequency of angina;Score of traditional Chinese medicine syndrome scale;Quality of life;Reduction rate of nitroglycerin;Electrocardiogram;Triglycerides;Total cholesterol;Low-density-lipoprotein cholesterol;High-density-lipoprotein cholesterol;Small and dense low-density lipoprotein cholesterol;Thrombin time;Fibrinogen;Activated partial thromboplastin time;Prothrombin time;Maximum platelet aggregation rate;Activation rate of antibody of Membrane glycoprotein;Initial average platelet volume;Plateletcrit;Platelet -larger cell ratio;Erythrocyte count;Mean corpuscular volume;Platelet adhesion rate;Erythrocyte Sedimentation Rate;Interleukin-6;Interleukin-10;Interleukin-17A;Transforming growth factor-ß;Curative effect of TCM syndrome;Seattle Angina Scale; | — |
Countries
China
Contacts
Public ContactLongtao Liu
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed