Ischemic Stroke
Conditions
Keywords
ischemic stroke, Mongolian Medicine ZhenBao Pills, efficacy, safety, randomized controlled trial
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.
Interventions
DRUGMongolian Medicine ZhenBao Pills
Mongolian Medicine ZhenBao Pills, orally, 15 pills each time, twice a day.
DRUGMongolian Medicine ZhenBao Pills Placebo
Mongolian Medicine ZhenBao Pills placebo, orally, 15 pills each time, twice a day.
Sponsors
Dongzhimen Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) scores | 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
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin scale (mRS) scores | 90 days after randomization | Difference in the distribution of patient mRS scores (mRS scores ranged from 0 to 6, with 0 to 1 indicating no disability, 2 to 5 indicating increasing disability, and 6 indicating death.) |
| FMA-UE scores | 30 days after randomization | Difference in FMA-UE scores between baseline and 30 days after randomization. |
| The Fugl-Meyer Assessment for Lower Extremity (FMA-LE)scores | 90 days after randomization | Difference in FMA-LE scores (range =0-34, with lower scores indicating more severe limb dysfunction) between baseline and 90 days after randomization. |
| National Institutes of Health Stroke Scale (NIHSS) scores | 90 days after randomization | Difference in NIHSS scores (range =0-42, with higher scores indicating more severe strokes) between baseline and 90 days after randomization. |
| The Barthel index of activity of daily living (BI) | 90 days after randomization | Difference in BI scores between baseline and 90 days after randomization. Functional independence will be measured with BI, which was a commonly used scale for measuring the activity of daily living of people. Score of 10-item scale ranges from 0 (worst) to 100 (best). |
| Visual analogue scale (VAS) scores | 90 days after randomization | Difference in VAS scores between baseline and 90 days after randomization. The patients' pain level measured with VAS, which was a conventionally used scale measuring the degree of the pain. Score of scale ranges from 0（best）to 10 (worst). |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORYing Gao, MD
Dongzhimen Hospital
Outcome results
None listed