This is a Ⅱa clinical trial. The purpose of this study is to preliminarily explore the optimal dosage of Xinglou Chengqi Granules in the treatment of acute ischemic stroke and to evaluate the efficacy and safety of Xinglou Chengqi Granules for acute ischemic stroke.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Patients will receive orally high-dose Xinglou Chengqi granules, combined with guidelines-based standard care.
Patients will receive orally low-dose Xinglou Chengqi granules, combined with guidelines-based standard care.
Dongzhimen Hospital, Beijing University of Chinese Medicine
Richmond, British Columbia, Canada
The change of NIHSS score from baseline to day 14.
The change of the National Institutes of Health stroke scale (NIHSS) score from baseline to day 14 will be analyzed between groups.
Time frame: Baseline and Day 14.
The proportions of patients with mRS ≤ 2 or mRS ≤ 1.
The proportions of patients with modified Rankin Scale (mRS) ≤ 2 or mRS ≤ 1 will be analyzed between groups.
Time frame: Day 30, Day 60 and Day 90.
The change of NIHSS score
The change of NIHSS score will be analyzed at days 7, 30, 60, and 90.
Time frame: Day 7, day 30, day 60, day 90.
The proportion of patients with Barthel Index score ≥ 95 or ≥ 75.
The proportion of patients with Barthel Index score ≥ 95 or ≥ 75 will be analyzed at days 7, 14, 30, 60, and 90.
Time frame: day 7, day 14, day 30, day 60, day 90.
The change of EQ-5D score.
The change of EQ-5D score from baseline to days 7, 14, 30, 60, and 90 will be analyzed between groups.
Time frame: day 7, day 14, day 30, day 60, day 90.
The incidence of new cardiovascular events.
The incidence of new cardiovascular events will be analyzed at day 7, 14, 30, 60, and 90.
Time frame: day 7, day 14, day 30, day 60, day 90.
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