The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology (한방안이비인후피부과학회지)

The Society of Korean Medicine Ophthalmology, Otolaryngology & Dermatology (대한한방안이비인후피부과학회)
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Explanation and Elaboration of the Clinical Trial Guidelines for Psoriasis Using Herbal Medicine

건선 치료용 한약제제에 대한 임상시험 가이드라인 설명 및 제언

  • Kim, Bong-Hyun (Department of Ophthalmology, Otolaryngology and Dermatology of Korean Medicine, College of Korean Medicine, Kyung Hee University) ;
  • Kim, Kwan-Il (Division of Allergy, Immune & Respiratory System, Department of Internal Medicine, College of Korean Medicine, Kyung Hee University) ;
  • Kang, Se-Hyun (Department of Ophthalmology, Otolaryngology and Dermatology of Korean Medicine, College of Korean Medicine, Kyung Hee University) ;
  • Park, Jung-Gun (Department of Ophthalmology, Otolaryngology and Dermatology of Korean Medicine, College of Korean Medicine, Kyung Hee University) ;
  • Kang, Dong-Won (Department of Ophthalmology, Otolaryngology and Dermatology of Korean Medicine, College of Korean Medicine, Kyung Hee University) ;
  • Nam, Hae-Jeong (Department of Ophthalmology, Otolaryngology and Dermatology of Korean Medicine, College of Korean Medicine, Kyung Hee University) ;
  • Kim, Yoon-Bum (Department of Ophthalmology, Otolaryngology and Dermatology of Korean Medicine, College of Korean Medicine, Kyung Hee University) ;
  • Lee, Jun-Hee (Korean Medicine Clinical Trial Center, Kyung Hee University Korean Medicine Hospital) ;
  • Kim, Kyu-Seok (Department of Ophthalmology, Otolaryngology and Dermatology of Korean Medicine, College of Korean Medicine, Kyung Hee University)
  • 김봉현 (경희대학교 한의과대학 안이비인후피부과) ;
  • 김관일 (경희대학교 한의과대학 폐계내과학교실) ;
  • 강세현 (경희대학교 한의과대학 안이비인후피부과) ;
  • 박중군 (경희대학교 한의과대학 안이비인후피부과) ;
  • 강동원 (경희대학교 한의과대학 안이비인후피부과) ;
  • 남혜정 (경희대학교 한의과대학 안이비인후피부과) ;
  • 김윤범 (경희대학교 한의과대학 안이비인후피부과) ;
  • 이준희 (경희대학교한방병원 한의약임상시험센터) ;
  • 김규석 (경희대학교 한의과대학 안이비인후피부과)
  • Received : 2018.04.06
  • Accepted : 2018.05.01
  • Published : 2018.05.25
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Abstract

Objectives : We report on the contents and reviews of the guidelines for clinical trials of herbal medicine for psoriasis. Methods : After reviewing the existing reports, the guidelines were drafted by the writing committee on guidelines for Korean medicine clinical trial center in Kyung Hee university Korean medicine hospital. Since then, the guidelines have been consulted by the experts in diseases, clinical trials and pharmaceuticals. In addition, the guidelines have been certified by the Korean medicine clinical trial center association and Korean Medicine Ophthalmology & Otolaryngology & Dermatology Society. Results : The guidelines for clinical trials are divided into 8 categories: (1) general contents, (2) evaluation standards of effectiveness, (3) outcome valuables, (4) selection of study participants, (5) designs of clinical trials, (6) safety evaluations, (7) combination therapies in psoriasis treatment and (8) Korean medical considerations. Conclusions : There are 3 major contents for discussion: (1) obscurity of Korean medical considerations to differentiate from existing guidelines, (2) the absence of Korean version of PASI and DLQI, which are validity parameters and (3) realistic institutional problem using the herbal medicine.

Keywords

References

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