Mechanism of Xinglouchengqi Decoction in Improving Nerve Injury in the Acute Stage of Stroke by EEG and Metabolomics

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Stroke

Intervention / Treatment
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* Drug: Xinglouchengqi decoction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Conventional treatment group<br>Western medicine treatment | |
| Combination treatment group<br>Xinglouchengqi decoction combined with western medicine treatment | Drug: Xinglouchengqi decoction<br>* the composition of Xinglouchengqi decoction: 9 g raw rhubarb, 9 g mirabilite, 6 g dananxing, 30 g quangualou decoction was uniformly prepared by the pharmacy department of our hospital. Decoction form was adopted, one dose per day, one dose of 200 mL decoction, and the decoction was taken in morning and evening twice and half an hour after meals. The observation period was 5 days: from 72 hours to 7 days after onset.<br>* Other names: 9 g raw rhubarb, 9 g mirabilite, 6 g dananxing, 30 g quangualou decoction;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| parameters of EEG | Brain network parameters based on EEG | Within 72 hours of onset | 
| parameters of EEG | Brain network parameters based on EEG | Day 5 | 
| parameters of EEG | Brain network parameters based on EEG | Day 7 | 
| LC-MS results | To explore the possible biomarkers, metabolic pathways, metabolic networks using blood and urine samples | Within 72 hours of onset | 
| LC-MS results | To explore the possible biomarkers, metabolic pathways, metabolic networks using blood and urine samples | Day 5 | 
| LC-MS results | To explore the possible biomarkers, metabolic pathways, metabolic networks using blood and urine samples | Day 7 | 
| NIHSS | Stroke Scale NIHSS | Within 72 hours of onset | 
| NIHSS | Stroke Scale NIHSS | day 5 | 
| NIHSS | Stroke Scale NIHSS | day 7 | 
| BI scale | To assess the activity of daily living scale Barthel Index (BI) | day 30 | 
| mRS scale | Modified Rankin Scale (mRS) | day 30 | 
| Head MRI | The location and size of the lesions were recorded in detail | Within 72 hours of onset |