ITMCTR2022000006尚未招募4 期
Research on the transformation and application of ancient classic famous recipes and comprehensive evaluation of Chinese patent medicines based on real-world research
Institute Of Basic Research In Clinical Medicine,China Academy Of Chinese Medical Sciences0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational study
入排标准
- 年龄范围
- 18 至 —（—）
- 性别
- All
入选标准
- •1. Age = 18 years, including male and female subjects;
- •2. Inpatients who meet the diagnostic criteria of Western medicine for stable angina (SA) and unstable angina (UA);
- •3. The frequency of angina pectoris = 2 times a week;
- •4. The patient, the patient's guardian, or the patient's family member signed the informed consent.
排除标准
- •1. Patients diagnosed with hemorrhagic stroke;
- •2. Recent major surgery history or comorbidities such as malignant tumors, serious dysfunction of cardiovascular, cerebrovascular, liver, kidney, hematopoietic system
- •3. Cognitive impairment, mental or neurological abnormalities that make unable to complete the questionnaire
- •4. Comorbidities with severe heart disease (heart function class III or IV), malignant hypertension (systolic blood pressure = 160 mm Hg or diastolic blood pressure = 100 mm Hg), severe heart failure (NYHA heart failure class IV), severe arrhythmia, PCI treatment within 3 months, use of a pacemaker, acute myocardial infarction, old myocardial infarction, pulmonary embolism, cardiomyopathy, aortic valve stenosis, and other heart valve diseases;
- •5. Situations that affect ST-T changes in ECG, such as myocardial hypertrophy, left bundle branch block, digitalis drug influence, electrolyte disturbance, etc.;
- •6. Chest pain caused by lesions other than coronary artery disease, such as psychosis, severe neurosis, hyperthyroidism, biliary heart syndrome, gastroesophageal reflux, aortic dissection, etc.;
- •7. Comorbidities such as severe hepatic and renal insufficiency (including dialysis treatment), active liver disease (including primary biliary cirrhosis and unexplained persistent hepatic insufficiency), alanine aminotransferase (ALT), Aspartate aminotransferase (AST) > 1.5 times the upper limit of normal, creatinine (Cr) clearance > 1.5 times the upper limit of normal, or total bilirubin (TBIL) = 2 times the upper limit of normal;
- •8. People with contraindications stated in the instructions of Dazhu Hongjingtian injection (pregnant women, allergic constitution, previous allergic to multiple drugs, allergic to the ingredients in the research drug, or a history of adverse reactions with Dazhu Hongjingtian preparation);
- •9. Control group who used Dazhu Hongjingtian (tablets, capsules, etc.) or other traditional Chinese medicine preparations for promoting blood circulation and removing blood stasis;
- •10. Patients who are considered inappropriate by other researchers to participate in this study.
研究者
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