NCT06049498CompletedNot Applicable
Efficacy and Safety of Mongolian Medicine ZhenBao Pills on Limb Function Recovery After Acute Ischemic Stroke: a Randomized Double-blinded Placebo-controlled Trial.
Dongzhimen Hospital, Beijing2 sites in 1 country216 target enrollmentStarted: January 1, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 216
- Locations
- 2
- Primary Endpoint
- The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) scores
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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-
- •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.
Arms & Interventions
Mongolian Medicine ZhenBao Pills group
Experimental
Experimental group
Intervention: Mongolian Medicine ZhenBao Pills (Drug)
Mongolian Medicine ZhenBao Pills Placebo-controlled group
Placebo Comparator
Placebo-controlled group
Intervention: Mongolian Medicine ZhenBao Pills Placebo (Drug)
Outcomes
Primary Outcomes
The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) scores
Time Frame: 90 days after randomization
Difference in FMA-UE scores (range =0-66, with lower scores indicating more severe limb dysfunction) between baseline and 90 days after randomization.
Secondary Outcomes
- Modified Rankin scale (mRS) scores(90 days after randomization)
- FMA-UE scores(30 days after randomization)
- The Fugl-Meyer Assessment for Lower Extremity (FMA-LE)scores(90 days after randomization)
- Visual analogue scale (VAS) scores(90 days after randomization)
- National Institutes of Health Stroke Scale (NIHSS) scores(90 days after randomization)
- The Barthel index of activity of daily living (BI)(90 days after randomization)
Investigators
Ying Gao
Professor
Dongzhimen Hospital, Beijing
Study Sites (2)
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