Trial of Mongolian Medicine ZhenBao Pills for Upper-limb Dysfunction After Stroke

Study Overview
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Brief Summary
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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
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The study is a randomized, double-blinded, placebo-controlled, multi-center trial.

Official Title
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Efficacy and Safety of Mongolian Medicine ZhenBao Pills on Limb Function Recovery After Acute Ischemic Stroke: a Randomized Double-blinded Placebo-controlled Trial.

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Drug: Mongolian Medicine ZhenBao Pills
* Drug: Mongolian Medicine ZhenBao Pills Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mongolian Medicine ZhenBao Pills group<br>Experimental group | Drug: Mongolian Medicine ZhenBao Pills<br>* Mongolian Medicine ZhenBao Pills, orally, 15 pills each time, twice a day.<br>|
| Placebo Comparator: Mongolian Medicine ZhenBao Pills Placebo-controlled group<br>Placebo-controlled group | Drug: Mongolian Medicine ZhenBao Pills Placebo<br>* Mongolian Medicine ZhenBao Pills placebo, orally, 15 pills each time, twice a day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) scores | Difference in FMA-UE scores (range =0-66, with lower scores indicating more severe limb dysfunction) between baseline and 90 days after randomization. | 90 days after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin scale (mRS) scores | 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.) | 90 days after randomization | 
| FMA-UE scores | Difference in FMA-UE scores between baseline and 30 days after randomization. | 30 days after randomization | 
| The Fugl-Meyer Assessment for Lower Extremity (FMA-LE)scores | Difference in FMA-LE scores (range =0-34, with lower scores indicating more severe limb dysfunction) between baseline and 90 days after randomization. | 90 days after randomization | 
| National Institutes of Health Stroke Scale (NIHSS) scores | Difference in NIHSS scores (range =0-42, with higher scores indicating more severe strokes) between baseline and 90 days after randomization. | 90 days after randomization | 
| The Barthel index of activity of daily living (BI) | 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). | 90 days after randomization | 
| Visual analogue scale (VAS) scores | 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). | 90 days after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemic stroke, Mongolian Medicine ZhenBao Pills, efficacy, safety, randomized controlled trial