Journal of Society of Preventive Korean Medicine (대한예방한의학회지)

Society of Preventive Korean Medicine (대한예방한의학회)
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Development of Clinical Trial Guidelines for Using Korean Herbal Medicine in Treatment of Common Cold

감기 치료를 위한 한약제제 임상시험 가이드라인 개발

  • Jiwon Park (Department of Clinical Korean Medicine, College of Korean Medicine, Graduate School, Kyung Hee University) ;
  • Kwan-Il Kim (Division of Allergy, Immune and Respiratory System, Department of Internal Medicine, College of Korean Medicine, Kyung Hee University)
  • 박지원 (경희대학교 대학원 임상한의학과) ;
  • 김관일 (경희대학교 한의과대학 폐계내과 폐계내과학교실)
  • Received : 2024.03.25
  • Accepted : 2024.04.17
  • Published : 2024.04.30
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Abstract

목적 : 본 연구는 감기에 대한 한약제제 임상시험을 수행하고 평가하는 데 보편적인 원칙을 제공하는 가이드라인 개발과정 및 내용을 소개하여 가이드라인 활용성 및 접근성을 높이고자 한다. 방법 : 임상시험 가이드라인 개발을 위해 총 9인으로 이루어진 위원회를 구성하고, 전반적인 절차를 수립하였다. 먼저, 가이드라인 집필위원회에서 관련된 국내외 가이드라인을 고찰하고, 감기에 대한 최신 임상시험 논문을 분석하여 초안을 완성하였다. 이후 대한한방내과학회 소속 전문가 자문위원회 검토 및 8인의 전문가로 구성된 협의회 자문을 통해 최종 가이드라인을 도출하였다. 결과 : 본 가이드라인은 (1) 일반적 사항 (2) 유효성 평가 기준 (3) 유효성 평가 방법 (4) 시험 대상자 선정 (5) 임상시험 설계 (6) 안전성 평가 (7) 감기 치료에서의 병용요법 (8) 한의학적 고려 사항의 8가지 범주로 나뉘어진다. 최종 개발된 가이드라인은 한의약임상시험센터 협의회와 대한한방내과학회의 인증을 득하였다. 결론 : 본 가이드라인은 감기 치료를 위한 임상시험을 수행하고 평가하는 데 유용하게 사용될 것이며, 이를 통해 신뢰할 수 있는 결과를 이끌어내고 정확한 해석을 용이하게 할 수 있을 것이라 기대된다. 또한 추후 해당 가이드라인 개정 및 관련된 호흡기질환 가이드라인 개발 과정에 도움을 줄 수 있을 것으로 사료된다.

Keywords

Acknowledgement

This research was supported by a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (grant number : HF23C0084) This study was supported by a grant from the Traditional Korean Medicine R&D Project, Ministry of Health & Welfare, Republic of Korea (HI13C0700).

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