An observational study in Stroke, sponsored by Peking University Third Hospital. Status unknown. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-07-21.
Sponsored by Peking University Third Hospital · Observational
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
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.
7,287 studies on the registry are indexed under Stroke; 2,006 are open to participants now.
This study's planned enrollment of 30 is below the median of 160 across 1,692 observational studies indexed under Stroke.
Browse Stroke studies →Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.
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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.
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.
Western medicine treatment
Xinglouchengqi decoction combined with western medicine treatment
Drug: Xinglouchengqi decoction
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.
Also known as: 9 g raw rhubarb, 9 g mirabilite, 6 g dananxing, 30 g quangualou decoction
parameters of EEG
Brain network parameters based on EEG
Time frame: Within 72 hours of onset
parameters of EEG
Brain network parameters based on EEG
Time frame: Day 5
parameters of EEG
Brain network parameters based on EEG
Time frame: Day 7
LC-MS results
To explore the possible biomarkers, metabolic pathways, metabolic networks using blood and urine samples
Time frame: Within 72 hours of onset
LC-MS results
To explore the possible biomarkers, metabolic pathways, metabolic networks using blood and urine samples
Time frame: Day 5
LC-MS results
To explore the possible biomarkers, metabolic pathways, metabolic networks using blood and urine samples
Time frame: Day 7
NIHSS
Stroke Scale NIHSS
Time frame: Within 72 hours of onset
NIHSS
Stroke Scale NIHSS
Time frame: day 5
NIHSS
Stroke Scale NIHSS
Time frame: day 7
BI scale
To assess the activity of daily living scale Barthel Index (BI)
Time frame: day 30
mRS scale
Modified Rankin Scale (mRS)
Time frame: day 30
Head MRI
The location and size of the lesions were recorded in detail
Time frame: Within 72 hours of onset
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Peking University Third Hospital