Rationale and Design of Naoxueshu Oral Liquid in Patients with Spontaneous Intracerebral Hemorrhage: A Multicentre, Randomized, Placebo-Controlled, Double-Blind Trial (ENSTAR) - Abstract
Background: Naoxueshu oral liquid (NXSOL) shows promise as a treatment for intracerebral hemorrhage (ICH), but its effectiveness lacks confirmation from large-scale randomized controlled trials. Our study aims to assess the efficacy and safety of NXSOL in non-surgical spontaneous ICH patients.
Methods and design: NXSOL in patients with spontaneous ICH (ENSTAR) is a multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial. Adult supratentorial SICH patients whose hematoma volume ?40ml, baseline National Institutes of Health Stroke Scale (NIHSS) ? 6 and ? 25, and Glasgow coma scale (GCS) ?9 within 72 hours after symptom onset are included. Patients who are scheduled for or have already undergone surgery treatment are excluded. Participants are randomly assigned, in a 1:1 ratio, to receive either NXSOL or placebo 10ml 3 times a day for 30 consecutive days. Both NXSOL and control groups will get standard western medical treatment. All will be followed up for 90 days. Primary efficacy outcome is the proportion of mRS ?2 at 90 days. Secondary efficacy outcomes include mortality within 90 days, changes in brain edema volume on computed tomography (CT) and NIHSS change at 7 and 14 days, cognitive function assessment and economic evaluation of drugs at 90 days. Safety outcomes are rate of hematoma expansion at 7 and 14 days, severe or moderate bleeding at 90 days.
Discussion: ENSTAR will provide evidence for the efficacy and safety of NXSOL in patients with SICH.
Strengths and limitations: Naoxueshu Oral Liquid in patients with Spontaneous Intracerebral Hemorrhage (ENSTAR) is a multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial and will evaluate the efficacy and safety of NXSOL in patients with SICH. Data will provide evidence for NXSOL use in spontaneous ICH patients. Insufficient sample size may be a limitation of this study.