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

• Published in: Medicine (Baltimore) 2021-11, Vol.100 (46), p.e27683-e27683
• Main Authors: Gao, Junfeng, Shao, Xiangzhong, Guan, YiXiang, Mei, Juxiang
• Format: Article
• Language: English
• Subjects: Brain Ischemia - drug therapy; Double-Blind Method; Drugs, Chinese Herbal - administration & dosage; Drugs, Chinese Herbal - therapeutic use; Humans; Ischemic Stroke - drug therapy; Randomized Controlled Trials as Topic; Study Protocol Clinical Trial
• ISSN: 0025-7974; 1536-5964
• DOI: 10.1097/MD.0000000000027683

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. 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. 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.