The Proteomic Study and Early Intervention Study of Carotid Unstable Plaque
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Changes in carotid artery unstable plaque
研究概览
简要总结
A study on the prediction model of carotid unstable plaque protein and its early intervention. Protein antibody chip was used to detect the remaining biological samples, and patients with carotid artery unstable plaque with stroke risk were selected for interventional clinical trials.
The selected patients were randomly divided into 3 groups, which were treated with Zhu's Wenban Formula (TCM compound granules), Qushi Formula (TCM compound granules) and placebo for 6 months, respectively. The size and number of carotid artery unstable plaques before and after 6 months were observed, and the occurrence of adverse reactions during the intervention period was observed.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Wet syndrome scale assessment is consistent with wet syndrome diagnosis;
- •Carotid color ultrasound indicated carotid artery unstable plaque.
- •Protein chip analysis determined that the patients were at high risk of stroke
- •Signing informed Consent
排除标准
- •Carotid artery stenosis rate ≥50%;
- •A definite or suspected diagnosis of vasculitis;
- •Accompanied by infection, tumor, heart, liver and renal insufficiency (liver and
- •kidney function more than twice the upper limit of normal value, cardiac function grade greater than or equal to 2);
- •Patients with acute stroke or complicated with acute myocardial infarction and unstable angina pectoris;
- •Pregnant or lactating women;
- •A prior known allergy to the test drug or the test drug ingredient.
研究组 & 干预措施
Placebo Group
Basic treatment according to the 2014 Chinese Guidelines for Secondary Prevention of Ischemic Stroke/Transient Ischemic Attack and placebo granules (6g/ bag, one bag each time, twice a day after meals);
干预措施: placebo (Drug)
Placebo Group
Basic treatment according to the 2014 Chinese Guidelines for Secondary Prevention of Ischemic Stroke/Transient Ischemic Attack and placebo granules (6g/ bag, one bag each time, twice a day after meals);
干预措施: Basic treatment (Other)
Qushi Formula Group
Basic treatment according to the 2014 Chinese Guidelines for Secondary Prevention of Ischemic Stroke/Transient Ischemic Attack and Qushi Formula granules (6g/ bag, one bag each time, twice a day after meals);
干预措施: Qushi Formula (Drug)
Qushi Formula Group
Basic treatment according to the 2014 Chinese Guidelines for Secondary Prevention of Ischemic Stroke/Transient Ischemic Attack and Qushi Formula granules (6g/ bag, one bag each time, twice a day after meals);
干预措施: Basic treatment (Other)
Zhu's Wenban Formula Group
Basic treatment according to the 2014 Chinese Guidelines for Secondary Prevention of Ischemic Stroke/Transient Ischemic Attack and Zhu's Wenban Formula granules (6g/ bag, one bag each time, twice a day after meals);
干预措施: Zhu's Wenban Formula (Drug)
Zhu's Wenban Formula Group
Basic treatment according to the 2014 Chinese Guidelines for Secondary Prevention of Ischemic Stroke/Transient Ischemic Attack and Zhu's Wenban Formula granules (6g/ bag, one bag each time, twice a day after meals);
干预措施: Basic treatment (Other)
结局指标
主要结局
Changes in carotid artery unstable plaque
时间窗: 6 moths
Changes in carotid IMT and the total volume and number of unstable plaques before and after 6 months of treatment
次要结局
- Changes in blood lipids(6 moths)
- Number of new cardiovascular events(12 moths)
研究者
jianwen guo, MD
professor
Guangzhou University of Traditional Chinese Medicine