The efficacy and safety of Jiedu Tongluo granules for treating post-stroke depression with qi deficiency and blood stasis syndrome: study protocol for a randomized controlled trial

Autor: Ai-mei Zhao, Wen-ran Qiu, Li-jun Mao, Jun-guo Ren, Li Xu, Ming-jiang Yao, Kellie Bilinksi, Dennis Chang, Jian-xun Liu
Jazyk: angličtina
Rok vydání: 2018
Předmět:
Zdroj: Trials, Vol 19, Iss 1, Pp 1-8 (2018)
Druh dokumentu: article
ISSN: 1745-6215
DOI: 10.1186/s13063-018-2633-4
Popis: Abstract Background Post-stroke depression (PSD) is the most common psychiatric complication after a stroke. The most frequently used antidepressants are selective serotonin receptor inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs), however, these exhibit a series of side effects. Traditional Chinese medicine has been used to treat PSD with few side effects. The aim of this study is to evaluate the efficacy and safety of Jiedu Tongluo granules for treating PSD with qi deficiency and blood stasis syndrome. Methods The planned study is a double-blind, randomized, placebo-controlled pilot trial. Eighty participants will be randomly assigned to receive either treatment or placebo. The treatment group will receive Jiedu Tongluo granules (JDTLG) with conventional treatment, and the placebo group will receive placebo with conventional treatment for 8 weeks. The primary outcome is the effectiveness of JDTLG on depression after 8 weeks treatment, which is defined as a decrease of 50% or more in 17-item Hamilton Depression Scale (HAMD-17) score or clinical recovery (score
Databáze: Directory of Open Access Journals
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