ITMCTR2100004438招募中4 期
Clinical Trial of Tongxinshu Capsule in Treating Stable Angina Pectoris of Coronary Heart Disease with Qi Deficiency and Blood Stasis Syndrome
试验速览
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) In line with the western medicine diagnostic criteria of coronary heart disease angina pectoris, angina more than 2 times per week attack I - III level in patients with angina pectoris;
- •2) TCM syndrome differentiation for qi deficiency and blood stasis;
- •3) Between the ages of 30 and 75, for both men and women;
- •4) Voluntary signing of informed consent.
排除标准
- •1) Acute myocardial infarction, unstable angina, stable fatigue angina pectoris IV level and other heart diseases.
- •2) Combined with poorly controlled hypertension and diabetes mellitus, severe cardiopulmonary insufficiency, severe arrhythmia (rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, etc.), and with a history of heart pacemaker and cerebrovascular disease within 1 year.
- •3) Percutaneous coronary intervention or coronary artery bypass graft was performed in the last 3 months
- •4) History or evidence of any of the following diseases during the screening period:
- •Serious cardiovascular disease;
- •Active, recurrent peptic ulcer or other the risk of hemorrhagic disease;
- •Other digestive serious illness;
- •Merger malignant tumor, blood system diseases, serious or progressive disease, or other system;
- •Merging other patients with mental illness to cooperation or unwilling to cooperate.
- •5) Before screening, any of the laboratory examination indicators shall meet the following standards:
- •Hospital kidney function tip: ALT, AST > 1.5 times the upper limit of normal, Cr > 1.2 times the upper limit of normal (in reference to the research center laboratory normal range).
- •Other laboratory examination with clinical significance is unusual, and the researchers of decision should not be set.
- •6) Suspected or proven history of alcohol or drug abuse.
- •7) Pregnant or lactating women or those who have planned to have a recent pregnancy and are unwilling to use contraceptive methods.
- •8) Patients who had participated in clinical trials of other drugs within 3 months before enrollment.
- •9) The investigator believes that it is inappropriate for the patients to participate in this clinical trial and for other reasons such as non-compliance and poor compliance.
研究者
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