摘要OBJECTIVE:To study the efficacy of Xiaoyao capsule(逍遥丸)in improving the clinical symptoms of sleep and mood disorders during recovery from coronavirus disease 2019(COVID-19).METHODS:The study cohort comprised 200 patients with sleep and mood disorders during recovery from COVID-19.Patients were randomized into the control group and the experimental group in a 1:1 ratio by blocked randomization.The patients received either Xiaoyao capsule(experimental group)or a placebo Xiaoyao capsule(control group)for 2 weeks.The improvements in the Traditional Chinese Medicine(TCM)syndrome scales,total effective rates,and disappearance rates of irritability,anxiety,and poor sleep were compared between the two groups.RESULTS:The TCM syndrome pattern scales,total effective rates,and disappearance rates of irritability,anxiety,and poor sleep did not significantly differ between the experimental group versus the control group in the full analysis set and the per protocol set after 1 and 2 weeks of treatment(P＞0.05).CONCLUSIONS:Xiaoyao capsule do not significantly improve the clinical symptoms of sleep and mood disorders in patients in recovery from COVID-19.