Clinical trial NCT06049498: Trial of Mongolian Medicine ZhenBao Pills for Upper-limb Dysfunction After Stroke
Official title: Efficacy and Safety of Mongolian Medicine ZhenBao Pills on Limb Function Recovery After Acute Ischemic Stroke: a Randomized Double-blinded Placebo-controlled Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ischemic Stroke
Keywords: ischemic stroke
Mongolian Medicine ZhenBao Pills
efficacy
safety
randomized controlled trial
Lead sponsor: Dongzhimen Hospital, Beijing
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Criteria:

1. Adult subjects (male or female ≥18 years).
2. The diagnosis of ischemic stroke should be met and the onset should be within 30 days.
3. Patients with prestroke modified Rankin scale score 0-1.
4. FAM-UE score of 20-57 at randomization.
5. The patients and legal guardians signed informed consent.

Exclusion Criteria:

1. 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).
2. 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).
3. Coagulation disorders or history of systemic hemorrhage.
4. Life expectancy is less than 3 months.
5. Unable to complete the study due to mental illness, cognitive or emotional impairment.
6. Suspected or known allergy to the components of the trial medication.
7. Pregnancy, breastfeeding or potential pregnancy.
8. Treatment within the last 3 months that may affect limb function, such as botulinum toxin injections or medications to improve limb motor function, etc.
9. Within three months or currently participating in another investigational study.
10. Other patients who, in the opinion of the investigator, are not suitable for participation of the study.

Primary outcomes:
measure: The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) scores
timeFrame: 90 days after randomization
Secondary outcomes:
measure: Modified Rankin scale (mRS) scores
timeFrame: 90 days after randomization
measure: FMA-UE scores
timeFrame: 30 days after randomization
measure: The Fugl-Meyer Assessment for Lower Extremity (FMA-LE)scores
timeFrame: 90 days after randomization
measure: National Institutes of Health Stroke Scale (NIHSS) scores
timeFrame: 90 days after randomization
measure: The Barthel index of activity of daily living (BI)
timeFrame: 90 days after randomization
measure: Visual analogue scale (VAS) scores
timeFrame: 90 days after randomization
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongzhimen Hospital, Beijing University of Chinese Medicine
Study officials:
affiliation: Dongzhimen Hospital
name: Ying Gao, MD
role: PRINCIPAL_INVESTIGATOR
References: