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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04970797
• Other study ID #: M2019430
• Status: Not yet recruiting
• Start date: September 1, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: June 2021
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Outcome

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