동의신경정신과학회지 (Journal of Oriental Neuropsychiatry)

  • 제29권1호
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  • Pages.35-46
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  • 2018
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  • 1226-6396(pISSN)
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  • 2234-4942(eISSN)
대한한방신경정신과학회 (The Korean Society of Oriental Neuropsychiatry)
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여성의 주요우울증에 대한 노에스액(육울탕)의 안전성, 유효성 평가 : 무작위배정, 양측눈가림, 위약대조, 평행설계 임상시험 프로토콜

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

  • 서영경 (대전대학교 둔산한방병원 임상시험센터) ;
  • 이은희 (대전대학교 한의과대학 신경정신과학교실) ;
  • 김환 (대전대학교 한의과대학 신경정신과학교실) ;
  • 이지윤 (대전대학교 한의과대학 신경정신과학교실) ;
  • 박채린 (대전대학교 둔산한방병원 임상시험센터) ;
  • 최선영 (한국한의학연구원 임상의학부) ;
  • 장은수 (대전대학교 한의과대학 진단학교실) ;
  • 권오진 (한국한의학연구원 임상의학부) ;
  • 김형준 (한국한의학연구원 임상의학부) ;
  • 정인철 (대전대학교 한의과대학 신경정신과학교실)
  • Seo, Young Kyung (Clinical Trial Center, Dunsan Korean Medicine Hospital of Daejeon University) ;
  • Lee, Eun Hee (Department of Oriental Neuropsychiatry, College of Korean Medicine, Daejeon University) ;
  • Kim, Hwan (Department of Oriental Neuropsychiatry, College of Korean Medicine, Daejeon University) ;
  • Lee, Ji-yoon (Department of Oriental Neuropsychiatry, College of Korean Medicine, Daejeon University) ;
  • Park, Chae Rin (Clinical Trial Center, Dunsan Korean Medicine Hospital of Daejeon University) ;
  • Choi, Sunyoung (Division of Clinical Medicine, Korea Institute of Oriental Medicine) ;
  • Jang, Eunsu (Department of Diagnosis, College of Korean Medicine, Daejeon University) ;
  • Kwon, Ojin (Division of Clinical Medicine, Korea Institute of Oriental Medicine) ;
  • Kim, Hyungjun (Division of Clinical Medicine, Korea Institute of Oriental Medicine) ;
  • Jung, In Chul (Department of Oriental Neuropsychiatry, College of Korean Medicine, Daejeon University)
  • 투고 : 2018.03.05
  • 심사 : 2018.03.17
  • 발행 : 2018.03.30
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초록

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 related 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 validity 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 related biological factors, and quality of life.

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