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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
216
Mongolian Medicine ZhenBao Pills, orally, 15 pills each time, twice a day.
Mongolian Medicine ZhenBao Pills placebo, orally, 15 pills each time, twice a day.
Dongzhimen Hospital, Beijing University of Chinese Medicine
Beijing, China
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.
Time frame: 90 days after randomization
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.)
Time frame: 90 days after randomization
FMA-UE scores
Difference in FMA-UE scores between baseline and 30 days after randomization.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 90 days after randomization
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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).
Time frame: 90 days after randomization