Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549582
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Th Tl Xb Prescription on Reprogramming of Lipid Metabolism and Endothelial Injury for Cerebral Infarction Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Taohong Tongluo Xiaoban Prescription on Reprogramming of Lipid Metabolism and Endothelial Injury for Cerebral Infarction Patientsa Randomized Controlled Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a prospective open-label randomized control trial It is planning to include 160 cerebral infarction patients which will be randomized in a 11 fashion to receive Chinese herbal medicines combined basic medicine treatment or to receive standard basic medicine treatment within 3 months after inclusion Follow-up will be performed after the treatment for 3 months to evaluate the incidence and disability rates of limb impairment language impairment cognitive impairment and emotional disorders The primary outcome is modified Rankin Scale Score which is measured by the overall distribution from 0 no symptoms to 6 death The secondary outcome include the Evaluation of Neurological Function Deficit score National Institute of Health stroke scale scoring and carotid atherosclerotic plaque score Crouse scoring system for neck carotid atherosclerotic plaque scoring Additional outcomes include laboratory indicator to analysis the reprogramming of lipid metabolism and endothelial Injury Chinese medicine symptom and sign scoring system and biological indicators The investigators will perform the intention-to-treat analysis for withdrawal and missing data and estimate the health economic value
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None