Clinical trial NCT04970797: Mechanism of Xinglouchengqi Decoction in Improving Nerve Injury in the Acute Stage of Stroke by EEG and Metabolomics
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: parameters of EEG
timeFrame: Within 72 hours of onset
measure: parameters of EEG
timeFrame: Day 5
measure: parameters of EEG
timeFrame: Day 7
measure: LC-MS results
timeFrame: Within 72 hours of onset
measure: LC-MS results
timeFrame: Day 5
measure: LC-MS results
timeFrame: Day 7
measure: NIHSS
timeFrame: Within 72 hours of onset
measure: NIHSS
timeFrame: day 5
measure: NIHSS
timeFrame: day 7
measure: BI scale
timeFrame: day 30
measure: mRS scale
timeFrame: day 30
measure: Head MRI
timeFrame: Within 72 hours of onset
Secondary outcomes:
Other outcomes:
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Study officials:
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