ITMCTR2100004684招募中未知
A randomized, double-blind, placebo-parallel controlled, multicenter clinical trial of efficacy and safety of Guhong injection in the treatment of unstable angina pectoris
Beijing Chaoyang Hospital, Capital Medical University0 个研究点开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 30 至 75（—）
- 性别
- All
入选标准
- •1. Volunteer to participate in the trial and sign the informed consent;
- •2. Age between 30 and 75 (including 30 and 75);
- •3. It meets the diagnostic criteria for unstable angina pectoris;
- •4. Patients with angina pectoris for at least 2 times within 10 days before enrollment;
- •5. Unstable angina pectoris, Braunwald grade I.
排除标准
- •1. Patients who need revascularization and/or are willing to undergo revascularization as determined by the investigator;
- •2. Patients with resting angina pectoris 48 hours before enrollment;
- •3. Chest pain caused by diseases other than coronary artery disease, such as severe neurosis, hyperthyroidism, cholecardiac syndrome, gastric and esophageal reflux, aortic dissection, etc.;
- •4. NYHA cardiac function grade III, IV; Left ventricular ejection fraction (LVEF) < 40%; Severe arrhythmia (such as rapid atrial fibrillation and flutter, paroxysmal ventricular tachycardia, II degree II type and III degree atrioventricular block) or other serious heart disease, or had a pacemaker installed within the last 3 months;
- •5. Severe respiratory diseases, such as respiratory failure;
- •6. Patients with liver, kidney, hematopoietic system and other serious diseases, including the normal upper limit of serum ALT and AST > and the normal upper limit of serum creatinine (SCR) BBB>
- •7. People with bleeding tendency;
- •8. Previous history of hemorrhagic disease, or current concurrent hemorrhagic disease;
- •9. Other factors affecting the evaluation of total load of ischemic myocardium, such as cardiac hypertrophy, left bundle branch block, digitalis, electrolyte disturbance, etc.;
- •10. Those who had taken traditional Chinese medicine for coronary heart disease or angina pectoris within 1 week before inclusion and had the effects of promoting qi, promoting blood circulation and removing blood stasis;
- •11. People with allergic constitution or known allergy to the test drug;
- •12. A history of mental illness or drug or alcohol abuse;
- •13. Women who are pregnant or lactating, or have a family planning plan during the study period;
- •14. Participating in clinical trials of other drugs within the last 3 months;
- •15. The investigator considers it inappropriate to participate in this clinical trial.
研究者
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