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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.
The study is a randomized, double-blinded, placebo-controlled, multi-center trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mongolian Medicine ZhenBao Pills group | Experimental | Experimental group |
|
| Mongolian Medicine ZhenBao Pills Placebo-controlled group | Placebo Comparator | Placebo-controlled group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mongolian Medicine ZhenBao Pills | Drug | Mongolian Medicine ZhenBao Pills, orally, 15 pills each time, twice a day. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ying Gao, MD | Dongzhimen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongzhimen Hospital, Beijing University of Chinese Medicine | Beijing | 100700 | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Mongolian Medicine ZhenBao Pills Placebo | Drug | Mongolian Medicine ZhenBao Pills placebo, orally, 15 pills each time, twice a day. |
|
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 |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |