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KMID : 0387420180290010035
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Korean Society of Oriental Neuropsychiatry
2018 Volume.29 No. 1 p.35 ~ p.46
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A Research to Evaluate the Safety and Efficacy of Yukwool-tang (Liuyu-tang) for Major Depression in Women: A Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial
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Seo Young-Kyung
Lee Eun-Hee
Kim Hwan
Lee Ji-Yoon
Park Chae-Rin
Choi Sun-Young
Jang Eun-Su
Kwon O-Jin
Kim Hyung-Jun
Jung In-Chul
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Abstract
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Objectives: The aim of this trial is to evaluate the efficacy and safety of Yukwool-tang (Liuyu-tang) for the treatment of major depression in women by comparing the Yukwool-tang (Liuyu-tang)-treated group with the placebo-treated group and assessing the association of various biological factors re-lated to depression through various outcome measures.
Methods: This study is a single-center, randomized, double-blind, placebo-controlled, parallel-design clinical trial. The subjects to be selected are women between the ages of 19 and 65, and the registered subjects are to be randomly assigned to treatment with Yukwool-tang or the placebo control. The Yukwool-tang group will take 1 bottle of Yukwool-tang (30 mg) for 8 weeks, 3 times a day, before meals. The control group will take the placebo in the same way. The primary outcome to be examined will be the change between the total score after 8 weeks and the total score before the start of the study of the K-HDRS score. Secondary outcomes are assessed by the change in total score after 12 weeks of K-HDRS, K-HDRS remission rate, K-HDRS improvement rate, BDI-K, PITD, KSCL-95, ISI, STAI-K, EQ-5D, VAS, Emotional Stimulation Test, BDNF test, inflammatory cytokine and tumor necrosis factor test, intestinal microbiome test, dietary report and Beck's hopelessness scale.
Results: This protocol has been approved by the IRB of Dunsan Korean Medicine Hospital of Daejeon University and is registered in the CRIS, and it is made public in advance to ensure transparency of the research process and conduct ethical clinical trials.
Conclusions: Based on this protocol, when the trial is completed, its data can be used to access the val-idity and safety of Yukwool-tang for major depression in women, and it is also expected to be helpful in the study of the correlation between future treatment of Korean medicine for depression and re-lated biological factors, and quality of life.
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KEYWORD
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Major depression of women, Yukwool-tang (Liuyu-tang), Study protocol, RCT
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