• ChunQin Ding, MingYang Xu, Li Gao, XiaoRong Wang, Wu Xu, MinWang Guo, and Jun Yao.
• Taixing People's Hospital, Department of Neurology, No.1 Changzheng Road, Taixing, Jiangsu Province, P.R. China.
• Medicine (Baltimore). 2021 Oct 22; 100 (42): e27318e27318.

BackgroundDepression is a common complication after stroke and is closely related to the poor prognosis of stroke. Antidepressants are the priority drug in the treatment of post-stroke depression (PSD), but there are dependence and adverse reactions. Danzhi Xiaoyao Powder has a good effect on depression without obvious adverse reactions. At present, there is a lack of rigorous randomized controlled trials to evaluate the clinical efficacy of Danzhi Xiaoyao Powder in the treatment of PSD.MethodsThis is a prospective, randomized, double-blind, parallel controlled trial to explore the efficacy and safety of Danzhi Xiaoyao Powder in the treatment of PSD. The participants were randomly divided into treatment group and control group. The treatment group used Danzhi Xiaoyao Powder combined with escitalopram oxalate, and the control group used Danzhi Xiaoyao Powder simulant combined with citalopram oxalate. The two groups were both treated for 8 weeks and followed up for 3 months. Observational index includes: Total response rate, Hamilton depression scale, Barthel index, national institutes of health stroke scale, the modified Edinburgh-Scandinavian stroke scale, Incidence of adverse reactions. Finally, SPASS 22.0 software was used for statistical analysis of the data.DiscussionThis study will evaluate the clinical efficacy of Danzhi Xiaoyao Powder in the treatment of PSD. The results of this study will provide reliable evidence for the clinical use of Xiaoyao Powder in the treatment of PSD.Trial RegistrationOpen Science Framework Registration number: DOI 10.17605/OSF.IO/5V926.Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.

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