Abstract
Introduction: HT047 is an herbal mixture extract of the Scutellaria baicalensis and Pueraria lobata plants, which have been widely used to treat ischemic stroke in traditional Korean medicine. The aims of this trial are to investigate whether HT047 can improve neurological status, particularly motor function, in acute ischemic stroke patients, and to determine the safety and tolerance of HT047. Methods: In this randomized, double-blind, placebo-controlled, parallel-group, phase II trial, we enrolled patients with acute ischemic stroke within the past 14 days from 8 centers in Korea. The participating patients must have a Fugl-Meyer Assessment (FMA) motor score ≤55 with arm or leg weakness, and Korean version of the National Institutes of Health Stroke Scale (K-NIHSS) score of ≥4 and ≤15. Seventy-eight participants will be randomized in a 1:1:1 ratio and given high-dose HT047 (750 mg three times a day), low-dose HT047 (500 mg three times a day), or a placebo for 12 weeks. The primary endpoint is the change in FMA motor score between baseline and week 12. The trial is registered with ClinicalTrials.gov, NCT02828540. Results: Between Aug, 2016, and Aug, 2018, we randomly assigned 78 patients to one of the three study groups, of whom 66 patients were assessed for the primary endpoint in full analysis set. The median (min, max) changes in FMA motor score of high-dose HT047 and low-dose HT047 were 24 (0, 63) and 43 (-2, 70) (placebo group=28 [0, 63], p=0.929 and p=0.705, respectively). The prevalence of favorable outcome defined as modified Rankin scale score of 0-2 were 47.6% (p=0.919) in high-dose HT047 group and 57.1% (p=0.106) in low-dose HT047 group (31.6% in placebo group). Adverse events were similar across the three study groups. Conclusions: This study is a first-in-human trial of HT047, and there were no between-group differences on the primary and secondary endpoints.
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