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Efficacy and Safety of ＂URSA Complex＂ in Subjects with Physical Fatigue： A Multicenter, Randomized, Double-blind, Placebo-controlled Trial

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Chinese Medical Journal 2016年第2期129卷 129-134页

作者： Kwang-Min Kim Moon-Jong Kim Sang-WookSong Doo-Yeoun Cho Kyung-Chae Park sung-wonyang Young-Sang Kim Kyung-Soo Kim Department of Family Practice and Community Health Ajou University School of Medicine Suwon Republic of Korea Department of Family Medicine CHA Bundang Medical Center CHA Medical University Sungnam Republic of Korea Department of Family Medicine St. Vincent's Hospital College of Medicine The Catholic University of Korea Seoul Republic of Korea Department of Family Medicine CMC Clinical Research Coordinating Center Seoul St. Mary's Hospital College of Medicine The Catholic University of Korea Seoul Republic of Korea

Background： Fatigue is a common symptom both in diseases status and in healthy subjects. Various supplements and nutraceuticals for relieving of fatigue have been used. However, there are a few studies to evaluate the efficacy and the safety of the drug tbr fatigue alleviation, we conducted using URSA Complex to evaluate the efficacy on physical fatigue via score changes in the checklist individual strength （CIS）. Methods： The study was designed as a multicenter, randomized, double-blind, placebo-controlled trial, with subjects randomized to one of the two arms, receiving either placebo or URSA Complex administered as identical capsules. The primary efficacy endpoints of this clinical trials are the ratio of improving CIS scores 〈 76 points in patients at the end （4 weeks）. Secondary efficacy variables are as follows one is an improvement of fatigue and the other is an improvement of the liver enzyme. Results： The fatigue recovery rate in who had improved CIS scores of 〈 76 points were 70.0%, 50.9% in the therapy group and placebo group, respectively （P = 0.0l 9）. The fatigue recovery rate in CIS score was higher in URSA Complex therapy group than placebo group. The difference between therapy group and placebo group was statistically significant at 4 weeks later, but not 2 weeks. Conclusions： Our results provided that the URSA Complex was effective in alleviating physical fatigue. The adverse event frequency in the therapy groups was similar to that in the placebo group.

关键词： Checklist Individual Strength Efficacy Physical Fatigue Safety URSA Complex

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