Efficacy and Safety of “URSA Complex” in Subjects with Physical Fatigue

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.

Clinical and Preclinical Systematic Review of Panax ginseng C. A. Mey and Its Compounds for Fatigue

“…All 8 studies ( Gal et al., 1996 ; Engels et al., 1996 ; Engels et al., 2001 ; Engels et al., 2003 ; Hartz et al., 2004 ; Hyeong-Geug et al., 2013 ; Kim et al., 2016 ; Lee et al., 2016 ) were RCTs, which involved a total of 678 participants, and the sample size ranged from 19 to 218. Five RCTs ( Gal et al., 1996 ; Hartz et al., 2004 ; Hyeong-Geug et al., 2013 ; Kim et al., 2016 ; Lee et al., 2016 ) involved 615 participants with CFS. The diagnostic criteria of patients with CFS were based on ECUCF.…”

“…The rest of 3 RCTs ( Engels et al., 1996 ; Engels et al., 2001 ; Engels et al., 2003 ) involved 63 healthy adults after exercise. They were published from 1996 to 2016 and conducted in America (n = 4) ( Engels et al., 1996 ; Engels et al., 2001 ; Engels et al., 2003 ; Hartz et al., 2004 ), South Korea (n = 3) ( Hyeong-Geug et al., 2013 ; Kim et al., 2016 ; Lee et al., 2016 ), and France (n = 1) ( Gal et al., 1996 ). The duration of treatment ranged from 4 to 8 weeks.…”

“…Five studies ( Engels et al., 1996 ; Engels et al., 2001 ; Engels et al., 2003 ; Hyeong-Geug et al., 2013 ; Kim et al., 2016 ) used objective evaluation criteria, including metabolic response and physical performance as outcome measure. Five studies ( Gal et al., 1996 ; Hartz et al., 2004 ; Hyeong-Geug et al., 2013 ; Kim et al., 2016 ; Lee et al., 2016 ) used self-reported fatigue measures, including Rand Vitality Index (RVI), Mood and Anxiety Symptom Questionnaire (MASQ), fatigue duration, checklist individual strength (CIS), Numeric Scale (NRS), Visual Analogue Scale (VAS), Visual Analogue Fatigue Scale (VAFS), Revised Piper Fatigue Scale (RPFS), Short-Form Health Survey (SF-36), Fatigue score, and clinical effect as outcome measure. The general characteristics of the 8 included articles were illustrated in Tables 1 and 2 .…”

“…Meta-analysis of 3 studies (Gal et al, 1996;Hartz et al, 2004;Kim et al, 2016) found significant difference in clinical effect for PGC relative to placebo (nT/nC =181/133, OR=1.31, 95% CI: 1.17 to 1.46, P < 0 00001; heterogeneity c 2 = 1.94, df = 2 (P=0.38), I 2 = 0%) ( Figure 2A). Meta-analysis of 5 studies (Gal et al, 1996;Hartz et al, 2004;Hyeong-Geug et al, 2013;Kim et al, 2016;Lee et al, 2016) showed there was no significant difference in the frequency of adverse events between the groups (nT/nC =293/297, OR=1.09, 95% CI: 0.48 to 2.46, P=0.83, heterogeneity c 2 = 6.99, df = 4 (P=0.14), I 2 = 0%) ( Figure 2B). Three studies (Engels et al, 1996;Engels et al, 2001;Engels et al, 2003) described the effect of PGC on physical performance recovery of healthy adults after exercise fatigue.…”

“…The placebo-control was used in all 8 studies. Five studies (Engels et al, 1996;Engels et al, 2001;Engels et al, 2003;Hyeong-Geug et al, 2013;Kim et al, 2016) used objective evaluation criteria, including metabolic response and physical performance as outcome measure. Five studies (Gal et al, 1996;Hartz et al, 2004;Hyeong-Geug et al, 2013;Kim et al, 2016;Lee et al, 2016)…”