Coronary heart disease angina pectoris
Conditions
Interventions
Test group:Take 8g of Hua Tuo Zai Zai Wan orally each time, 3 times/day
Control group:Take 8g of Hua Tuo Zai Zai Wan simulant orally each time, 3 times daily
Test group:Oral administration of Hua Tuo Zai Zai Wan 8g + 5 tablets of simulated Dang Ju tablets each time, 3 times/day
Control group:Take 5 tablets of Danggu tablets + 8g of Hua Tuo Zai Zai Wan simulant orally each time
Sponsors
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: ?Those who meet the diagnostic criteria of coronary angina pectoris. ? Those who meet the diagnostic criteria of stable exertional angina. ?Those who meet the diagnostic criteria of exertional angina ?, ? and ? (the first stage mainly includes grade ? and ?). ?Those who meet the criteria for identification of phlegm-stasis blocking evidence in Chinese medicine. ? Patients with an average of =2 episodes of angina pectoris per week in the 4 weeks prior to enrollment. ?Plain ECG with ischemic manifestations: ST-segment decrease = 0.1mv and/or R-wave as the dominant association T-wave inversion and deep > 0.2mv; plain ECG with ischemic manifestations. 0.2 mv; if the ST segment of general ECG decreased =0.05 mv and <0.1 mv, the exercise plate test was positive (for details, see the protocol).(Annex: Exercise plate test SOP). ? Age: 35-70 years old (35-65 years old in the first stage, and relaxed to 70 years old in the second stage). ? Subjects were informed and signed an informed consent form. After meeting the above inclusion criteria, there was no introduction period for the first treatment cases or withdrawal cases that could not be controlled with other drugs.After meeting the above enrollment criteria, there will be no introduction period for primary cases or withdrawal cases that cannot be controlled by other drugs; if the subject is taking other drugs that can control chest pain, an introduction period of at least one week is required if he/she is willing to enroll. The introductory period may include the use of Placebo. (See the combined medication regulations for more information)
Exclusion criteria
Exclusion criteria: ?Meet the above inclusion criteria but have one of the following: had a myocardial infarction at least 3 months prior to the trial.Presence of pre-infarction symptoms; occurrence of angina pectoris at rest; presence of any disorder that may invalidate the study results. ?Examination confirmed coronary artery disease acute myocardial infarction and other cardiac diseases, severe neurosis, menopausal syndrome (i) The presence of coronary artery disease such as acute myocardial infarction and other cardiac diseases, severe neurosis, menopause, hyperthyroidism, cervical spondylosis, biliary heart disease, gastric and esophageal reflux, esophageal hiatal hernia, aortic coarctation (ii) Chest pain caused by lesions other than coronary artery disease. (iii) Combined hypertension and high blood pressure (systolic blood pressure = 160 mmHg, diastolic blood pressure = 100 mmHg) even after treatment with antihypertensive drugs.100 mmHg), severe cardiopulmonary insufficiency, severe arrhythmias (rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, etc.), serious diseases of the liver, kidney, hematopoietic system, etc. renal, hematopoietic system and other serious primary diseases, and patients with psychiatric disease. ?Patients with coronary artery disease, within six months of complete revascularization after coronary artery bypass and interventional treatment. ? Allergic patients or those who are allergic to known drug components. ? Patients who have used drugs with serious effects on liver and kidney function within the past month. ? Those who have participated in other clinical trials within the last month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Attack frequency of angina pectoris;Angina pectoris combined efficacy rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured and decreasing values of the number of angina attacks;Angina duration measured versus decreasing values;Nitroglycerin use measured and decreased values;Nitroglycerin stopping reduction rate;Disappearance rate of angina pectoris;Total angina score;Electrocardiographic efficacy;Chinese medicine evidence of efficacy;Measured and decreasing values of total TCM evidence points;Disappearance rate of single indicators of TCM symptoms;Measured and decreasing values of experimental indicators of active plate; | — |
Countries
China
Contacts
Public ContactLanjun Sun
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed