Abstract
OBJECTIVE: To evaluate the efficacy and safety of Shuxuening injection, a Chinese remedy from Ginkgo biloba, in treating patients with acute ischemic stroke (AIS). METHODS: A randomized, double-blind, placebo-controlled, multi-center clinical trial was conducted from 21 November 2018 to 20 January 2022 in 31 participating research centers involving 446 patients with AIS. Patients received either a Shuxuening injection (experimental group) or a placebo (control group) alongside basic treatment (aspirin enteric-coated tablets). The primary efficacy endpoint was the percentage of patients with a modified Rankin scale (mRS) score ≤ 2 at 90-day post-stroke. The secondary efficacy endpoints were the changes in mRS, National Institute of Health stroke scale (NIHSS), and Barthel index (BI) scores, and the incidence of adverse events. RESULTS: The percentage of patients with mRS scores ≤ 2 at 90-day post-stroke was significantly higher in the experimental than in the control (P < 0.05) group. The percentage of patients with scores ≤ 1 at 90-day post-stroke was higher in the experimental group (P < 0.05). The change value of NIHSS scores in the experimental group was higher at 10-day post-treatment and 90-day post-stroke (P < 0.05). The percentage of NIHSS score reduction ≥ 50% was higher in the experimental group at 90-day post-stroke (P < 0.05). The change value of BI score and percentage of BI score ≥ 75 were higher in the experimental group at 90-day post-stroke (P < 0.05). Safety profiles did not differ between the groups. CONCLUSION: Shuxuening injection effectively improves the functional outcome of patients, reduces disability rates, improves neurological deficits, enhances activities of daily living, and demonstrates good safety profiles.