The purpose of this study is to assess the effectiveness and safety of Qingre Huatan formula versus placebo on preventing early neurological deterioration in patients with acute ischemic stroke within 48 hours after onset.
Inpatients diagnosed with acute ischemic stroke. Inpatients diagnosed of acute ischemic stroke.
Meet the criteria of TCM phlegm-heat syndrome
Patients at high-risk of END : Magnetic resonance imaging (MRI) reveals new ischemic lesions, with DWI-ASPECTS score ≤ 7, or presence of at least two risk factors of END.
Acute ischemic stroke within 48 hours after onset.
Received or planned thrombolysis or endovascular therapy after onset.
Suspected secondary stroke caused by brain tumor, brain trauma, hemopathy, etc.
Already dependent in activities of daily living before the present acute stroke (defined as modified Rankin Scare score ≥2 )
Diseases that cause motor dysfunction, including osteoarthritis, etc.
Parallel
Qingre Huatan Formula
DrugQingre Huatan Formula, granules, 1 bag each time, twice a day, orally, continue for 10 days.
Qingre Huatan Formula placebo
DrugQingre Huatan Formula placebo, granules, 1 bag each time, twice a day, orally, continue for 10 days.
Guidelines-based standard care
Other interventionGuidelines-based standard care for acute ischemic stroke
The incidence of early neurological deterioration within 7 days of onset
An increase of NIHSS ≥2 within 7 days of onset is considered as early neurological deterioration. The NIHSS (National Institute of Health Stroke Scale) is a neurological assessment tool for stroke patients, with scores ranging from 0 to 42.
Change in National Institute of Health Stroke Scale scores from baseline to 10 days (after the treatment)
The NIHSS (National Institute of Health Stroke Scale) is a neurological assessment tool for stroke patients, with scores ranging from 0 to 42. Scores of 0-1 indicate near normal status, 1-4 mild stroke, 5-15 moderate stroke, 16-20 moderate-to-severe stroke, and 21-42 severe stroke. It is primarily used to quickly assess stroke severity and guide treatment decisions.
The proportion of patients with modified Rankin Scale score ≤2 on day 30
The mRS (modified Rankin Scale) is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranging from 0 (no symptom) to 5 (severe disability) and 6 (death).
The proportion of patients with modified Rankin Scale score ≤2 on day 90
The mRS (modified Rankin Scale) is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranging from 0 (no symptom) to 5 (severe disability) and 6 (death).
Activity of daily living of patients measured by Barthel Index score on day 30
Barthel Index is 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).
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