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

• Published in: Chinese medical journal Vol. 129; no. 2; pp. 129 - 134
• Main Authors: Kim, Kwang-Min, Kim, Moon-Jong, Song, Sang-Wook, Cho, Doo-Yeoun, Park, Kyung-Chae, Yang, Sung-Won, Kim, Young-Sang, Kim, Kyung-Soo
• Format: Journal Article
• Language: English
• Published: China Wolters Kluwer - Medknow Publications 20.01.2016; Medknow Publications and Media Pvt. Ltd; Lippincott Williams & Wilkins Ovid Technologies; 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; Medknow Publications & Media Pvt Ltd; Wolters Kluwer
• Subjects: Adult; Care and treatment; Checklist Individual Strength; Efficacy; Physical Fatigue; Safety; URSA Complex; Chronic fatigue syndrome; Clinical trials; Cognition & reasoning; Complications and side effects; Double-Blind Method; Double-blind studies; Exercise; Family medical history; Fatigue; Fatigue - drug therapy; Hepatitis; Hospitals; Humans; Inositol - therapeutic use; Kinases; Medicine; Metabolism; Middle Aged; Original; Panax - chemistry; Physical fitness; Physicians; Plant Extracts - chemistry; Proteins; Rodents; Studies; Taurine - adverse effects; Taurine - therapeutic use; Thiamine - therapeutic use; Treatment Outcome; Tuberculosis; Ursodeoxycholic Acid - adverse effects; Ursodeoxycholic Acid - therapeutic use; Vitamin B; 体力; 多中心; 大熊星座; 对照试验; 疗效; 综合治疗; 身体疲劳; 随机; United States; Checklist Individual Strength; Efficacy; URSA Complex; Physical Fatigue; Safety
• ISSN: 0366-6999; 2542-5641; 2542-5641
• DOI: 10.4103/0366-6999.173432

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.