The efficacy and safety of Anyu Peibo Capsule in the treatment of patients with major depressive disorder in China: study protocol for a randomized placebo-controlled trial

被引：1
|
作者：
Huang, Jingjing [1 ]
Yu, Yimin [1 ]
Jiang, Yi [2 ]
Chen, Wu [2 ]
Li, Yan [1 ]
Shen, Yifeng [1 ]
Zheng, Qingshan [3 ]
Li, Huafang [1 ]
机构：
[1] Shanghai Jiao Tong Univ, Shanghai Mental Hlth Ctr, Sch Med, 600 Wan Ping Nan Rd, Shanghai 200030, Peoples R China
[2] Su Zhou YiHua Biotechnol Co Ltd, Suzhou, Peoples R China
[3] Shanghai Univ Tradit Chinese Med, Shanghai, Peoples R China
来源：
TRIALS | 2021年 / 22卷 / 01期
关键词：
Depression; Anyu Peibo Capsule; Randomized controlled trials; MEDICINAL-PLANTS; GLOBAL IMPRESSION; SCALE; ANTIDEPRESSANT;
D O I：
10.1186/s13063-021-05550-9
中图分类号：
R-3 [医学研究方法]; R3 [基础医学];
学科分类号：
1001 ;
摘要：
Background: Major depressive disorder is the second leading cause of years lost to disability worldwide. Anyu Peibo Capsule has been shown to be effective and safe in phase II trials. Methods: This clinical study is a multi-center, randomized, double-blinded, placebo-controlled, parallel-group, phase III trial of Anyu Peibo Capsule in China. The aim is to test whether the administration of Anyu Peibo Capsule compared to placebo improves clinical outcomes in adults (aged 18 to 65 years) with MDD. Patients will receive an 8-week treatment of Anyu Peibo Capsule 1.6 g per day or placebo. The primary outcome will be the change from baseline in the total score for the Montgomery-Asberg Depression Rating Scale at the end of the 8-week treatment. Discussion: The trial aims to provide pivotal evidence for the efficacy and safety of Anyu Peibo Capsule in patients with major depressive disorder.
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页数：9
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