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KMID : 0615720100270040195
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Jouranl of Korean Acupuncture and Moxibustion society
2010 Volume.27 No. 4 p.195 ~ p.202
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Adverse Event Study on Ojeok-san Extract Powders RCT in Low Back Pain Patients
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Yoon Eun-Hye
Jang Min-Gee
Hwang Ji-Hoo
Lee Seung-Hoon
Jung Won-Je
Lee Jae-Dong
Lee Seung-Deok
Kim Kyung-Ho
Kim Kap-Sung
Kim Eun-Jung
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Abstract
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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 But 5patients(2.8%) were withdrawn from the research because of the adverse events.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.
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KEYWORD
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Ojeok-san extract powders, adverse event
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