StrokeNCT04970797
Mechanism of Xinglouchengqi Decoction in Improving Nerve Injury in the Acute Stage of Stroke by EEG and Metabolomics
An observational study of Stroke, run by Peking University Third Hospital.
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 Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Xinglouchengqi decoction
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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
Read the 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
- Being tested
- Xinglouchengqi decoction
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xinglouchengqi decoctionDrug
Also called 9 g raw rhubarb, 9 g mirabilite, 6 g dananxing, 30 g quangualou 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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment group | Western medicine treatment | |
| Combination treatment group | Xinglouchengqi decoction combined with western medicine treatment Receives: Drug: Xinglouchengqi decoction |
What is being measured
The primary outcome is the main question the study is designed to answer.
parameters of EEG
Brain network parameters based on EEG
Measured: Within 72 hours of onset
parameters of EEG
Brain network parameters based on EEG
Measured: Day 5
parameters of EEG
Brain network parameters based on EEG
Measured: Day 7
LC-MS results
To explore the possible biomarkers, metabolic pathways, metabolic networks using blood and urine samples
Measured: Within 72 hours of onset
LC-MS results
To explore the possible biomarkers, metabolic pathways, metabolic networks using blood and urine samples
Measured: Day 5
LC-MS results
To explore the possible biomarkers, metabolic pathways, metabolic networks using blood and urine samples
Measured: Day 7
NIHSS
Stroke Scale NIHSS
Measured: Within 72 hours of onset
NIHSS
Stroke Scale NIHSS
Measured: day 5
NIHSS
Stroke Scale NIHSS
Measured: day 7
BI scale
To assess the activity of daily living scale Barthel Index (BI)
Measured: day 30
mRS scale
Modified Rankin Scale (mRS)
Measured: day 30
Head MRI
The location and size of the lesions were recorded in detail
Measured: Within 72 hours of onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start1 Sep 2021 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin Xiyan, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970797
- Sponsor's protocol ID
- M2019430
- Status last verified
- Jun 2021
- First submitted
- 2 Jul 2021
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04970797
- Acronym / sponsor ID
- M2019430
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment group | – | –Western medicine treatment |
| Combination treatment group | – | Drug: Xinglouchengqi decoctionXinglouchengqi decoction combined with western medicine treatment |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xinglouchengqi decoctionAlso: 9 g raw rhubarb, 9 g mirabilite, 6 g dananxing, 30 g quangualou decoctionthe 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. | Drug | Combination treatment group |
Primary outcome
parameters of EEG
Time frame: Within 72 hours of onset
Brain network parameters based on EEG
parameters of EEG
Time frame: Day 5
Brain network parameters based on EEG
parameters of EEG
Time frame: Day 7
Brain network parameters based on EEG
LC-MS results
Time frame: Within 72 hours of onset
To explore the possible biomarkers, metabolic pathways, metabolic networks using blood and urine samples
LC-MS results
Time frame: Day 5
To explore the possible biomarkers, metabolic pathways, metabolic networks using blood and urine samples
LC-MS results
Time frame: Day 7
To explore the possible biomarkers, metabolic pathways, metabolic networks using blood and urine samples
NIHSS
Time frame: Within 72 hours of onset
Stroke Scale NIHSS
NIHSS
Time frame: day 5
Stroke Scale NIHSS
NIHSS
Time frame: day 7
Stroke Scale NIHSS
BI scale
Time frame: day 30
To assess the activity of daily living scale Barthel Index (BI)
mRS scale
Time frame: day 30
Modified Rankin Scale (mRS)
Head MRI
Time frame: Within 72 hours of onset
The location and size of the lesions were recorded in detail
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Peking University Third Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
parameters of EEG (time frame: Within 72 hours of onset). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.