• Journal of Acupuncture Research
• /
• 제27권4호
• /
• pp.195-202
• /
• 2010

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 But 5patients(2.8%) were withdrawn from the research because of the adverse events.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.

• Journal of Acupuncture Research
• /
• 제27권2호
• /
• pp.105-113
• /
• 2010

Objectives : This study was performed to analyze the quality of Ojeok-san extract powders distributed in Korea. Methods : HPLC analyses of Ojeok-san decoction produced in laboratory and 8 kinds of Ojeok-san extract powders were done. Also, quantity analyses of paeoniflorin in Paeonia lactiflora, Glycyrrhizin in Glycyrrhiza uralensis, alkaloid in Ephedra sinica, Hesperidin in Citrus unshiu Markovich, and cinnamic acid in Cinnamomum cassia Blume were performed to investigate the accurate content of 6 kinds of Ojeok-san extract powders. Results : In the pattern analysis, the peaks were compared. The content of components in herbal extract powders was 14.7 to 15.8% of that of decoction in average. The range was measured from 8.5 to 25.7%. The pattern comparison showed significant differences among the pharmaceutical companies' products. As for the quantity analysis, one of herbal extract powder contained insufficient amount of Paeonia lactiflora components and one of herbal extract powder was in short of Ephedra sinica components. All of the others contained more than standard component(over 90%). Conclusions : Because herbal extract powders are also medicine, standardized manufacturing methods and consistent quality management are necessary. Therefore exaction and operation of national standards and various researches to improve the quality management of herbal extract powders is urgent.