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临床试验/NCT04970797
NCT04970797Unknown不适用

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

Peking University Third Hospital0 个研究点目标入组 30 人开始时间: 2021年9月1日最近更新:
适应症
干预措施
相关药物

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xin Xiyan

Attending physician

Peking University Third Hospital

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