BNG-1 in the recovery of acute ischemic stroke: A phase 2, double-blind, placebo-controlled randomized trial

Purpose: Few strategies have been approved for acute therapy of ischemic stroke in Western medicine. Hundreds of traditional Chinese medicines (TCMs) have been used for stroke therapy and were rarely tested by qualified studies. To evaluate the efficacy and safety of BNG-1, a novel mixture of TCMs, in patients with acute ischemic stroke, we conducted the clinical trial. Methods: This was a Phase 2, double-blind, placebo-controlled study in which the safety and efficacy of orally administered BNG-1 based on oral aspirin 100 mg daily for consecutive 14 days were measured in patients with acute ischemic stroke within 10 days after onset. The primary efficacy endpoint was the functional status assessed by the Barthel Index. The safety was evaluated by the incidence of adverse events and significant changes in vital signs, parameters of physical and laboratory examinations. Results: There were 42 patients randomized for the intention-to-treat efficacy analysis. The study failed to prove the significantly statistical difference of efficacy assessment between patients receiving BNG-1 and placebo in the recovery of acute ischemic stroke. The clinical and laboratory safety profiles had no significant difference between two groups. Conclusions: BNG-1 trial was feasible, safe and well tolerated for patients with acute ischemic stroke based on the treatment of aspirin, though there was no statistically significant difference of efficacy between BNG-1 and placebo groups. A further large Phase 3 trial of BNG-1 is needed before recommending such treatments for general clinical use.