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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Stroke
• Intervention / Treatment: Drug: Xinglouchengqi decoction

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.

• Study Type: Observational
• Enrollment (Anticipated): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Conventional treatment group; Western medicine treatment
Combination treatment group; 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.; Other Names: 9 g raw rhubarb, 9 g mirabilite, 6 g dananxing, 30 g quangualou decoction

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: July 2, 2021
• First Submitted That Met QC Criteria: July 12, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 12, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: M2019430

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No