title: Efficacy and Safety of "URSA Complex" in Subjects with Physical Fatigue: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial.
abstract: 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 for 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 = 0.019). 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.
authors.forename: Kwang-Min
authors.initials: KM
authors.lastname: Kim
authors.forename: Moon-Jong
authors.initials: MJ
authors.lastname: Kim
authors.forename: Sang-Wook
authors.initials: SW
authors.lastname: Song
authors.forename: Doo-Yeoun
authors.initials: DY
authors.lastname: Cho
authors.forename: Kyung-Chae
authors.initials: KC
authors.lastname: Park
authors.forename: Sung-Won
authors.initials: SW
authors.lastname: Yang
authors.forename: Young-Sang
authors.initials: YS
authors.lastname: Kim
authors.affiliation: 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.
authors.forename: Kyung-Soo
authors.initials: KS
authors.lastname: Kim
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D005221:Fatigue / Q000188:drug therapy*; D006801:Humans; D007294:Inositol / Q000627:therapeutic use; D008875:Middle Aged; D005894:Panax / Q000737:chemistry; D010936:Plant Extracts / Q000737:chemistry; D013654:Taurine / Q000009:adverse effects / Q000627:therapeutic use*; D013831:Thiamine / Q000627:therapeutic use; D016896:Treatment Outcome; D014580:Ursodeoxycholic Acid / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D010936:Plant Extracts; D013654:Taurine; D007294:Inositol; D014580:Ursodeoxycholic Acid; D013831:Thiamine
references.citation: Evid Based Complement Alternat Med. 2012;2012:130875
references.pmid: 21966297
references.citation: Rom J Gastroenterol. 2005 Sep;14(3):259-66
references.pmid: 16200237
references.citation: Hepatol Res. 2008;38(2):123-31
references.pmid: 18034825
references.citation: BMC Med. 2010;8:35
references.pmid: 20550693
references.citation: Compr Psychiatry. 1990 Mar-Apr;31(2):140-51
references.pmid: 2178863
references.citation: Gut. 2007 Dec;56(12):1747-53
references.pmid: 17573387
references.citation: Postgrad Med J. 1997 Feb;73(856):75-80
references.pmid: 9122101
references.citation: J Pharmacol Sci. 2013;123(4):328-35
references.pmid: 24257438
references.citation: Occup Environ Med. 2000 May;57(5):353-7
references.pmid: 10769302
references.citation: Free Radic Biol Med. 2005 Sep 1;39(5):584-9
references.pmid: 16085177
references.citation: BMJ. 2005 Jan 1;330(7481):14
references.pmid: 15585538
references.citation: Rheumatology (Oxford). 2011 Jun;50(6):1009-18
references.pmid: 21285230
references.citation: J Ethnopharmacol. 2010 Jul 20;130(2):421-3
references.pmid: 20580802
references.citation: J Orthop Sci. 2003;8(3):415-9
references.pmid: 12768487
references.citation: J Exerc Nutrition Biochem. 2013 Dec;17(4):189-98
references.pmid: 25566430
references.citation: J Psychosom Res. 2010 Jul;69(1):81-9
references.pmid: 20630266
references.citation: Acta Physiol (Oxf). 2009 May;196(1):81-98
references.pmid: 19245656
references.citation: Curr Opin Neurol. 1996 Dec;9(6):456-60
references.pmid: 9007405
references.citation: BMC Gastroenterol. 2013;13:140
references.pmid: 24053454
references.citation: Amino Acids. 2002 Jun;22(4):309-24
references.pmid: 12107759
references.citation: J Lipid Res. 2003 May;44(5):935-42
references.pmid: 12611908
references.citation: J Occup Health Psychol. 2000 Oct;5(4):411-6
references.pmid: 11051524
references.citation: J Intern Med. 2014 Dec;276(6):543-59
references.pmid: 24824502
references.citation: J Lipid Res. 2009 Sep;50(9):1721-34
references.pmid: 19417220
references.citation: PLoS One. 2013;8(4):e61271
references.pmid: 23613825
references.citation: BMC Gastroenterol. 2013;13:155
references.pmid: 24172289
references.citation: World J Gastroenterol. 2009 Jun 14;15(22):2782-6
references.pmid: 19522030
references.citation: Can J Appl Physiol. 2000 Jun;25(3):153-64
references.pmid: 10932033