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KMID : 1189420180310020040
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Journal of Korean Oriental Medical Ophthalmology & Otolaryngology & Dermatology
2018 Volume.31 No. 2 p.40 ~ p.59
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Explanation and Elaboration of the Clinical Trial Guidelines for Psoriasis Using Herbal Medicine
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Kim Bong-Hyun
Kim Kwan-Il
Kang Se Hyun
Park Jung-Gun
Kang Dong-Won
Nam Hae-Jeong
Kim Yoon-Bum
Lee Jun-Hee
Kim Kyu-Seok
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Abstract
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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.
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KEYWORD
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Psoriasis, clinical trial guidelines, Herbal medicine
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