대한한방내과학회지 (The Journal of Internal Korean Medicine)

대한한방내과학회 (The Society of Internal Korean Medicine)
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기능성 소화불량 한의 변증 표준화를 위한 이중탕, 평위산 및 시호소간탕 투여 : 무작위 배정, 평가자 눈가림, 3군 비교, 평행 설계, 공개, 다기관 임상시험 프로토콜

Administration of Yijung-tang, Pyeongwi-san, and Shihosogan-tang for Standardization of Korean Medicine Pattern Identification for Functional Dyspepsia: A Study Protocol of a Randomized, Assessor-blind, 3-Arm, Parallel, Open-label, Multicenter Clinical Trial

  • 조민진 (동국대학교 한의과대학 한방재활의학교실) ;
  • 이보람 (한국한의학연구원 한의과학연구부) ;
  • 최영은 (한국한의학연구원 임상연구협력팀) ;
  • 권오진 (한국한의학연구원 한의과학연구부) ;
  • 임미영 (한국식품연구원, 식품기능연구본부, 맞춤형식이연구단) ;
  • 고석재 (경희대학교 한의과대학 비계내과학교실) ;
  • 김소연 (부산대학교 한방병원 한방내과) ;
  • 김용주 (상지대학교 한의과대학 방제학교실) ;
  • 남동현 (상지대학교 한의과대학 진단생기능의학교실) ;
  • 최동준 (동국대학교 일산한방병원 한방내과) ;
  • 이준환 (한국한의학연구원 한의과학연구부) ;
  • 박재우 (경희대학교 한의과대학 비계내과학교실) ;
  • 김호준 (동국대학교 한의과대학 한방재활의학교실)
  • Min-Jin, Cho (Dept. of Rehabilitation Medicine of Korean Medicine, College of Korean Medicine, Dongguk University) ;
  • Boram, Lee (KM Science Research Division, Korea Institute of Oriental Medicine) ;
  • Young-Eun, Choi (Clinical Research Coordinating Team, Korea Institute of Oriental Medicine) ;
  • Ojin, Kwon (KM Science Research Division, Korea Institute of Oriental Medicine) ;
  • Mi Young, Lim (Personalized Diet Research Group, Food Functionality Research Division, Korea Food Research Institute) ;
  • Seok-Jae, Ko (Dept. of Gastroenterology, College of Korean Medicine, Kyung Hee University) ;
  • So-yeon, Kim (Dept. of Korean Internal Medicine, Korean Medicine Hospital of Pusan National University) ;
  • Yongjoo, Kim (Dept. of Herbal Medicine, College of Korean Medicine, Sangji University) ;
  • Donghyun, Nam (Dept. of Diagnostics and Biofunctional Medicine, College of Korean Medicine, Sangji University) ;
  • Dong-Jun, Choi (Dept. of Internal Korean Medicine, Dongguk University Ilsan Oriental Medical Hospital) ;
  • Jun-Hwan, Lee (KM Science Research Division, Korea Institute of Oriental Medicine) ;
  • Jae-Woo, Park (Dept. of Gastroenterology, College of Korean Medicine, Kyung Hee University) ;
  • Hojun, Kim (Dept. of Rehabilitation Medicine of Korean Medicine, College of Korean Medicine, Dongguk University)
  • 투고 : 2022.11.29
  • 심사 : 2022.12.19
  • 발행 : 2022.12.30
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초록

Objectives: The purpose of this study is to explore the effectiveness and safety of frequently used clinical herbal medicines (Yijung-tang [Lizhong-tang, LJT], Pyeongwi-san [Pingwei-san, PWS], and Shihosogan-tang [Chaihu Shugan-tang, SST]) in patients with functional dyspepsia (FD) when administered according to herbal medicine and Korean medicine pattern identification. The results of this study will be used to standardize the diagnostic instrument used in Korean medicine and to investigate biomarkers of Korean medicine pattern identification. Methods: This study will be a randomized, assessor-blind, 3-arm, parallel, open-label, multi-center clinical trial. A total of 300 FD participants will be recruited from 3 Korean medical hospitals and assigned to the LJT (n=100), PWS (n=100), and SST (n=100) groups according to FD pattern identification. The patients will take the medication for 8 weeks, 3 times a day, before or between meals. The primary outcome will be total dyspepsia symptom (TDS) and the secondary outcomes will be adequate relief (AR) for dyspepsia, overall treatment effect (OTE), visual analogue scale (VAS), functional dyspepsia-related quality of life (FD-QoL), gastrointestinal symptom score (GIS), and pattern identification questionnaires. For the exploratory outcomes, we will analyze blood and fecal metabolome profiles, microbiota from fecal and saliva samples, single nucleotide polymorphism (SNP), and results of Korean medicine diagnosis device measurements (heart rate variability, and tongue, pulse, and abdominal diagnosis). Conclusions: The results of this study will prove objectivity for Korean medicine pattern identifications, and the effectiveness and safety of herbal medicines for the population with FD.

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과제정보

본 임상연구는 한국연구재단 바이오⋅의료기술 개발사업(NRF-2022M3A9E4017033)의 지원에 의해 이루어짐.

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