대한예방한의학회지 (Journal of Society of Preventive Korean Medicine)

대한예방한의학회 (Society of Preventive Korean Medicine)
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만성피로에 대한 공진단과 쌍화탕의 안전성 및 유효성 평가를 위한 무작위배정, 이중눈가림, 위약대조 임상시험 : 임상연구 프로토콜

Randomized, Double-blind, and Placebo-controlled a Clinical Study for Chronic Fatigue via the Analysis of Efficacy and Safety of Gongjin-dan and Ssanghwa-tang : Study Protocol

  • 최준용 (부산대학교한방병원 한방내과) ;
  • 임병묵 (부산대학교 한의학전문대학원 인문사회의학교실) ;
  • 신현규 (한국한의학연구원 한의과학연구부) ;
  • 김기봉 (부산대학교 한의학전문대학원)
  • Jun-Yong, Choi (Department of Korean Internal Medicine, Pusan National University Korean Medicine Hospital) ;
  • Byungmook, Lim (Division of Humanities and Social Medicine, School of Korean Medicine, Pusan National University) ;
  • Hyeun-kyoo, Shin (KM Science Research Division, Korea Institute of Oriental Medicine) ;
  • Kibong, Kim (School of Korean Medicine, Pusan National University)
  • 투고 : 2022.12.01
  • 심사 : 2022.12.26
  • 발행 : 2022.12.31
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초록

Objectives : The purpose of this study is to confirm the efficacy and safety of Gongjin-dan and Ssanghwatang for chronic fatigue. Methods : A total of 90 people, between 19 and 65 years old, will be recruited to participate in a randomized, double-blind, and placebo-controlled a clinical trial. Participants in the Gongjin-dan group will take one pill of Gongjin-dan along with three packs of placebo oral liquid Ssanghwa-tang per day for 4 weeks. Participants in the Ssanghwa-tang group will take three packages of liquid Ssanghwa-tang and one placebo Gongjindan pill per day for 4 weeks. In the placebo group, participants will take one pill of placebo Gongjin-dan and three packs of placebo liquid Ssanghwa-tang per day, for 4 weeks. Outcomes will be measured at the baseline, 4th week, and 6th week. The primary outcome is the change in the Fatigue Severity Scale (FSS). Secondary outcomes are the change of Multidimensional Fatigue Inventory-20 (MFI-20), Chalder Fatigue Scale (CFQ), Short-Form 36 Health Survey (SF-36), Korean Version of Schedule of Fatigue and Anergy/General Physician (SOFA/GP), Glucose, Lactate, Ammonia, Free Fatty Acid (FAA), d-ROMs&BAP, Selenium, and Cortisol. Results : This trial was approved by the institutional review board of Pusan National University Korean Medicine Hospital (registry number: PNUKHIRB 2021-10-005). Recruitment opened in November 2021 and is supposed to be completed by December 2022. Conclusions : This trial will provide clinical information to determine the efficacy and safety of Gongjindan and Ssanghwa-tang for chronic fatigue.

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과제정보

본 연구는 한국한의학연구원의 한방의료기관 한약처방 안전성 유효성 근거 구축사업의 지원을 받아 수행되었음(grant numbers: KSN2013310, KSN2021310).

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