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KMID : 0608520090150030083
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Korean Journal of Oriental Medicine
2009 Volume.15 No. 3 p.83 ~ p.91
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A 4 week Randomized, Double-blind Human Trial to Compare the Efficacy and Safety of Aureobasidium pullulans Cultured Solution and Placebo on Improvement of Immune in Subjects
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Choi Hae-Yun
Kim Jong-Dea
Park Mee-Yeon
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Abstract
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β-glucan is a fiber-type complex sugar (polysaccharide) derived from the cell wall of baker’s yeast, oat and barley fiber, and many medicinal mushrooms, such as maitake. The primary uses of β-glucan are to enhance the immune system, to lower blood cholesterol levels and to treat tumor. β-glucan has no systemic toxicity in mice, therefore it needed clinical trail to prove efficacy and safety for human. The subjects total 56 healty volunteers were divided into two groups including taken β-glucan tablet group and placebo group. Subjects were taken two tablets per oral for 4 weeks. They had agreed to take part in this experiment, and didn`t take any other clinical trail products.After 4 weeks blood of subjects were checked. The check list are TNF-α, INF-γ, IL-2, IL-4, total WBC, differential WBC, RBC, hemoglobin, platelet, MCV, MCH, MCHC, HCT, Na, K, Ca, Cl, AST, ALT, ALP, γ-GTP, total protein, triglyceride, total cholesterol, total bilirubin, albumin, uric acid, creatinine, BUN, pH, protein, glucose, ketone body, blood, bilirubin. We evaluated efficacy by cytokines that compare before and after taking. Collected data were analyzed as two sample t-test, chi-square test and ANOVA using SAS V.9.1.This study results are that in TNF-α of 1st efficacy measurement item, all of two groups figure were increased significantly compare to before figure. In IL4 of 2nd efficacy measurement item, experimental group figure were decreased significantly but placebo group figure were increased. The conclusions show that based on the above results, β-glucan has favorable effect to enhance immune system, especially IL4 results showed that it has effect to improve the allergic immune system.
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KEYWORD
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β-glucan, IL4, Immune system, Clinical Trial
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