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요통환자 대상 오적산 엑스산 투여 임상시험 이상반응 연구
윤은혜,장민기,황지후,이승훈,정원제,이재동,이승덕,김경호,김갑성,김은정,Yoon, Eun-Hye,Jang, Min-Gee,Hwang, Ji-Hoo,Lee, Seung-Hoon,Jeong, Won-Je,Lee, Jae-Dong,Lee, Seung-Deok,Kim, Kyung-Ho,Kim, Kap-Sung,Kim, Eun-Jung 대한침구의학회 2010 대한침구의학회지 Vol.27 No.4
Objectives : This study was performed to report adverse events in Ojeok-san extract powders RCT. Methods : 180 patients with LBP were randomized into groups for a double blind, placebo-controlled clinical study. They received Ojeok-san simple Extract, Ojeok-san complex Extract or placebo in powders, orally dissolved 3times a day for 4weeks. During 4weeks, we researched the symptoms and duration of adverse events and Digest ability, Milk hypersensitivity, Starch hypersensitivity, Caramel hypersensitivity, West-med hypersensitivity, Herb-med hypersensitivity in patients who had adverse events. Results : 52patients(28.9%) had adverse events and of them 44patients(28.9%) had lost adverse events naturally. But 5patients(2.8%) were withdrawn from the research because of the adverse events. Most of the symptoms of adverse event was Gastrointestinal symptom(88.3%) and adverse events frequency was not different from Ojeok-san simple Extract, Ojeok-san complex Extract and placebo. Conclusions : Ojeok-san extract powders had adverse events no different from the placebo, which shows that it is a safe drug.