A Randomized, Double-blind, Placebo-controlled Study of ShenJu in the Treatment of Hyperlipidemia Combined With Carotid Atherosclerosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Arm and ankle pulse wave velocity
研究概览
简要总结
This study focuses on PWV as the main outcome, aiming to evaluate the efficacy and safety of ShenJu in treating patients with hyperlipidemia combined with carotid atherosclerosis, and provide a basis for traditional Chinese medicine treatment of hyperlipidemia combined with carotid atherosclerosis.
详细描述
Hyperlipidemia is very harmful and easy to cause atherosclerosis. Atherosclerosis is the main factor of carotid atherosclerosis. Carotid atherosclerosis and plaque are usually the characteristic manifestations of atherosclerosis. Carotid arteriosclerosis is closely related to stroke, and carotid arteriosclerosis, rupture and detachment of carotid plaques, carotid stenosis and occlusion can all lead to the occurrence of cerebrovascular events. Early detection and evaluation of hyperlipidemia with carotid atherosclerosis by various means can effectively reduce the risk of cardiovascular and cerebrovascular diseases. In order to better serve the vast number of patients, Professor Wang Lei has developed ShenJu granules based on traditional Chinese medicine prescriptions and years of clinical experience. Compared to decoction, ShenJu granules have a higher concentration, are more convenient to carry, and are easy to absorb. They have received unanimous praise from patients in clinical applications.
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
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has informed consent and signed the informed consent form
- •Age between 18-65 years old
- •Meet the diagnostic criteria for hyperlipidemia and accompanied by carotid arteriosclerosis
- •Meet the diagnostic criteria of TCM wet certificate: refer to the scoring standard of TCM Wet Disease Scale
排除标准
- •Severe liver, kidney and cardiac insufficiency
- •Any other serious disease or condition such as: malignant tumor, uncontrolled severe hypertension, diabetic ketoacidosis (acute complication/vascular abnormality), arrhythmia, coagulation abnormalities
- •Have participated in another clinical study within 30 days prior to enrollment or have received a history of randomized ketoacidosis in this study
- •Pregnant women, women preparing to become pregnant and lactating women
- •Patients who are allergic to relevant Chinese medicine ingredients
- •Patients who have had a stent inserted
- •Patients who the investigator determines are not suitable to participate in this study
结局指标
主要结局
Arm and ankle pulse wave velocity
时间窗: At enrollment versus at day 90
Measures the degree of carotid artery sclerosis
次要结局
- Indicators of carotid atherosclerosis(At enrollment versus at day 90)
- TCM wet evidence(At enrollment versus at day 90)
- Blood glucose(At enrollment versus at day 90)
- Lipid indexes(At enrollment versus at day 90)
研究者
Lei Wang,MD
Chief Physician
Guangdong Provincial Hospital of Traditional Chinese Medicine