Trial of Mongolian Medicine ZhenBao Pills for Upper-limb Dysfunction After Stroke (TREASURE)
Ischemic Stroke
About this trial
This is an interventional treatment trial for Ischemic Stroke focused on measuring ischemic stroke, Mongolian Medicine ZhenBao Pills, efficacy, safety, randomized controlled trial
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Sites / Locations
- Dongzhimen Hospital, Beijing University of Chinese Medicine
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Mongolian Medicine ZhenBao Pills group
Mongolian Medicine ZhenBao Pills Placebo-controlled group
Experimental group
Placebo-controlled group