Effect of Danhong injection on neurological recovery and adverse events in patients with acute ischemic stroke: A protocol for a randomized, double-blind, placebo-controlled clinical study

BACKGROUND: Acute ischemic stroke (AIS) is characterized by high disabling and recurrent recurrence, and its severe neurological impairment and vascular adverse events (AEs) limit the recovery of patients. Danhong injection is a complementary alternative to the treatment of AIS, and previous studies have demonstrated its efficacy and safety. However, there is no long-term follow-up and rigorous clinical study to evaluate the effect of Danhong injection on neurological recovery and AEs in patients with AIS. METHODS: This is a prospective randomized, double-blind, placebo-controlled trial investigating the effect of Danhong injection on neurological recovery and AEs in patients with AIS. Participants were randomly divided into treatment and control groups in a 1:1 ratio. The treatment group was treated with Danhong injection and the control group were treated with placebo under the guideline recommended basic treatment. After 14 days of continuous treatment, the follow-up period was 6 months. Observation indicators include: National Institute of Health Stroke Scale, modified Rankin scale, symptomatic intracranial hemorrhage, the incidence of new major vascular events within 6 months, and all-cause mortality. Finally, the data were analyzed statistically using the SPASS 22.0 software. DISCUSSION: This study will evaluate the effect of Danhong injection on neurological recovery and AEs in AIS. The results will provide a reference for the clinical use of AIS.