ITMCTR2100005440尚未招募4 期
Evaluation of the clinical efficacy of Guanxinning tablets in the treatment of patients with carotid atherosclerotic plaque
Dongzhimen Hospital, Beijing University of Chinese Medicine0 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
- Interventional study
入排标准
- 年龄范围
- 18 至 75（—）
- 性别
- All
入选标准
- •(1) Participate voluntarily, understand and sign the informed consent form
- •(2) Age =18 years old and =75 years old, regardless of gender
- •(3) Meet the diagnostic criteria: IMT=1.5mm, protruding from the vascular cavity or limited thickening,
- •And higher than 50% of the surrounding IMT
- •(4) Syndrome differentiation accords with TCM Heart and Blood Stasis Syndrome
排除标准
- •(1) Carotid artery plaque stenosis =70%
- •(2) History of carotid endarterectomy
- •(3) Poor hypertension control, defined as resting at two independent examinations before randomization
- •Systolic blood pressure =180mmHg and/or diastolic blood pressure =110mmHg
- •(4) Occurred within 3 months: acute coronary syndrome, stroke, transient brain deficiency
- •Blood attack; heart, carotid or other large blood vessel surgery; percutaneous coronary intervention or carotid movement
- •Angioplasty or coronary artery bypass graft and other heart surgery
- •(5) Major surgery within 6 months before randomization
- •(6) Patients with hemoglobin concentration =9g/dL and/or blood system diseases
- •(7) Patients with heart failure and severe arrhythmia (persistent rapid atrial fibrillation, atrial flutter, frequent
- •Ventricular premature, ventricular tachycardia, atrioventricular block above second degree), or combined with liver, kidney, hematopoietic system,
- •Nervous system, endocrine system and other serious primary diseases, tumor patients and mental patients
- •(8) Life expectancy is less than 1 year
- •(9) Participated in other drug clinical trials within 1 month
- •(10) Known to be allergic to the research drug (including its ingredients)
- •(11) Patients who are taking Chinese medicines or proprietary Chinese medicines that have similar ingredients to Guanxinning tablets or have the effect of resolving phlegm and turbidity
- •(12) Pregnancy (positive pregnancy test) or breastfeeding; failure to take medicine
- •Use women of childbearing age (15-49 years old) who observe strict contraceptive measures
- •(13) According to the judgement of the investigator, the patient cannot complete the study or cannot comply with the requirements of the study
- •Demand (due to management reasons or other reasons)
研究者
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