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

NCT ID: NCT04970797

Last Updated: 2021-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-09-01

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.

Conditions

Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Conventional treatment group

Western medicine treatment

No interventions assigned to this group

Combination treatment group

Xinglouchengqi decoction combined with western medicine treatment

Xinglouchengqi decoction

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

9 g raw rhubarb, 9 g mirabilite, 6 g dananxing, 30 g quangualou decoction

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xin Xiyan

Attending physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

M2019430

Identifier Type: -

Identifier Source: org_study_id