Status:
UNKNOWN
Trial of Mongolian Medicine ZhenBao Pills for Upper-limb Dysfunction After Stroke
Lead Sponsor:
Dongzhimen Hospital, Beijing
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The trial was designed to test the hypothesis that treatment with Mongolian Medicine ZhenBao Pills has a positive effect on upper-limb motor recovery after acute ischemic stroke.
Detailed Description
The study is a randomized, double-blinded, placebo-controlled, multi-center trial.
Eligibility Criteria
Inclusion
- Adult subjects (male or female ≥18 years).
- The diagnosis of ischemic stroke should be met and the onset should be within 30 days.
- Patients with prestroke modified Rankin scale score 0-1.
- FAM-UE score of 20-57 at randomization.
- The patients and legal guardians signed informed consent.
Exclusion
- Cranial CT or MRI findings of hemorrhage or other pathologic brain disorders, such as vascular malformations, tumors, abscesses, encephalitis, or other common non-ischemic brain diseases (e.g., multiple sclerosis).
- Chronic liver disease or elevated ALT, AST (greater than two times the upper limit of normal), renal insufficiency or elevated blood creatinine (greater than 1.5 times the upper limit of normal).
- Coagulation disorders or history of systemic hemorrhage.
- Life expectancy is less than 3 months.
- Unable to complete the study due to mental illness, cognitive or emotional impairment.
- Suspected or known allergy to the components of the trial medication.
- Pregnancy, breastfeeding or potential pregnancy.
- Treatment within the last 3 months that may affect limb function, such as botulinum toxin injections or medications to improve limb motor function, etc.
- Within three months or currently participating in another investigational study.
- Other patients who, in the opinion of the investigator, are not suitable for participation of the study.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT06049498
Start Date
October 1 2023
End Date
December 31 2025
Last Update
September 22 2023
Active Locations (1)
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1
Dongzhimen Hospital, Beijing University of Chinese Medicine
Beijing, China, 100700