Randomized Controlled Clinical Study on Vulnerable Plaque of Carotid Artery With Chinese Herbal and Insects Medicine
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 主要终点
- The total number of all-cause mortality and all-cause stroke within 12 months
研究概览
简要总结
The investigators want treat Vulnerable plaque of carotid artery with a herbal and insects Chinese medicine. Designing a RCT trial to prove the effect and safety.
详细描述
Vulnerable plaque of carotid artery is the important intervention target for primary prevention and secondary prevention of cerebral arterial thrombosis, but there are no effective, safe and prevalent treatment measures against it. The development that traditional Chinese medicine has achieved in treating plaque of carotid artery shows that great accomplishment could be made within this area. Academia should engage in clinical research on regulated treatment methods in traditional Chinese medicine with long-term intervention and high patient compliance, providing strong evidence for evidence-based medicine and guidance to clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria of carotid artery atherosclerosis;
- •Ultrasound of carotid artery atherosclerosis plaque specifies it as unstable plaque (including malacoplakia and mixed plaque);
排除标准
- •mRS Rating higher than or equal to 3 before joining the trail group;
- •Carotid artery stenosis is higher than or equal to 50%;
- •Confirmed as or suspected to be vasculitis;
- •With infection, tumor or insufficient heart, liver and kidney functions (renal function higher than twice of upper limit in normal limit, HYHA heart function grading higher than or equal to level 2 );
- •With acute myocardial infarction and unstable angina pectoris;
- •With acute cerebral arterial thrombosis;
- •lesion: Severe stenosis or occlusion of distal intracranial vessels;
- •Pregnant women or lactating mothers;
- •With known history of allergy to the drugs of the trial.
研究组 & 干预措施
Herbal Medicine C-117
Herbal Medicine C-117 Prescription (6g/bag，one bag each time, twice a day.) for 6 months
干预措施: Herbal Medicine C-117 (Drug)
The Placebo of Herbal Medicine C-117
Placebo of Herbal Medicine C-117 (6g/bag，one bag each time, twice a day.) for 6 months
干预措施: The Placebo of Herbal Medicine C-117 (Drug)
结局指标
主要结局
The total number of all-cause mortality and all-cause stroke within 12 months
时间窗: 1 years
After drug-use 6 months, observe all-cause mortality and all-cause stroke (hemorrhage or ischemic).
次要结局
- The number of Vulnerable plaque of carotid artery through color ultrasound(6 months)
- The nature of Vulnerable plaque of carotid artery through color ultrasound(6 months)
- Blood lipid levels(6 months)