Using EEG and Metabolomics to Evaluate the Clinical Efficacy of Xinglouchengqi Decoction in Improving Nerve Injury in the Acute Stage of Stroke and the Mechanism
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- parameters of EEG
研究概览
简要总结
Using EEG and metabolomics to evaluate the clinical efficacy of Xinglouchengqi decoction in improving nerve injury in the acute stage of stroke and the mechanism
详细描述
Traditional Chinese medicine treatment is the original advantage in China for early stroke intervention. Xinglouchengqi decoction is an important prescription for the treatment of acute stage of stroke proposed by Academician Wang Yongyan. Early intervention can significantly improve the condition of patients and reduce the degree of neurological function deficit, but its mechanism of action is not clear.EEG, network graph theory and metabonomics are applied in evaluating the treatment of stroke, and to explore the mechanism of Xinglouchengqi decoction to improve the nerve injury of acute stroke patients. 30 stroke patients with acute period will be as the research object, using the observational cohort studies, to measure the dynamic of nerve function defect, EEG signals and other clinical information. Based on EEG to construct the brain functional network in the acute stage of stroke and to study the brain network mechanism of Xinglouchengqi decoction in improving the nerve injury of patients. Meanwhile, based on the study of metabolomics, the potential biomarkers and the metabolic pathway will be analyse to explore the pharmacodynamic substance.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •those who met the diagnostic criteria for acute anterior circulation ischemic stroke; first stroke, no previous history of organic encephalopathy; the onset is less than 72 hours; it is in line with the TCM diagnosis of phlegm heat; aged 40 to 80 years old.
排除标准
- •Transient Ischemic Attack (TIA) ; those who have received thrombolytic therapy; the examination confirmed that the stroke was caused by the brain tumor, brain trauma or blood disease; cerebral embolism caused by rheumatic heart disease, coronary heart disease and other heart disease combined with atrial fibrillation; complicated with liver and kidney hematopoietic system endocrine system and other serious diseases and osteoarthropathy; prior mental disorder or severe dementia; patients with concurrent infection and fever; patients with primary or secondary epilepsy; those who had taken sedative drugs or sleeping drugs 3 days before the examination.
研究组 & 干预措施
Combination treatment group
Xinglouchengqi decoction combined with western medicine treatment
干预措施: Xinglouchengqi decoction (Drug)
结局指标
主要结局
parameters of EEG
时间窗: Day 7
Brain network parameters based on EEG
LC-MS results
时间窗: Day 7
To explore the possible biomarkers, metabolic pathways, metabolic networks using blood and urine samples
NIHSS
时间窗: day 7
Stroke Scale NIHSS
BI scale
时间窗: day 30
To assess the activity of daily living scale Barthel Index (BI)
mRS scale
时间窗: day 30
Modified Rankin Scale (mRS)
Head MRI
时间窗: Within 72 hours of onset
The location and size of the lesions were recorded in detail
次要结局
未报告次要终点
研究者
Xin Xiyan
Attending physician
Peking University Third Hospital
