PMID- 32724321 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220415 IS - 1741-427X (Print) IS - 1741-4288 (Electronic) IS - 1741-427X (Linking) VI - 2020 DP - 2020 TI - Effectiveness and Safety of Panax ginseng Extract on Hepatic Dysfunction: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. PG - 2689565 LID - 10.1155/2020/2689565 [doi] LID - 2689565 AB - BACKGROUND: The purpose of this study was to evaluate the efficacy and safety of Panax ginseng extract (GS-KG9) in the treatment of hepatic dysfunction. METHODS: A randomized, double-blind, placebo-controlled clinical trial was conducted from December 2017 to January 2019. The trial included 60 subjects between the ages of 19 and 70 who had higher alanine transaminase (ALT) levels than the normal upper limit. The subjects were randomly divided into two groups: GS-KG9 (n = 30) and placebo (n = 30). The former was administered three GS-KG9 capsules (3 g/day) and the latter three placebo capsules (3 g/day) twice each day orally after meals in the morning and evening for 12 weeks. The primary goal was to observe the changes in ALT and gamma-glutamyl transferase (GGT) levels. The safety of the treatment was assessed and adverse events (AEs) were recorded. RESULTS: Out of 60 subjects, nine were excluded from the efficacy analysis because they met the exclusion criteria. Therefore, a total of 51 subjects were evaluated for the effectiveness of the treatment (26 in the GS-KG9 group and 25 in the placebo group). After 12 weeks of treatment, the ALT levels were significantly reduced in the GS-KG9 group compared to the placebo group (p=0.009). The GGT level of the GS-KG9 group was significantly lower than that of the placebo group (p=0.036). Mild AEs, such as diarrhea, occurred during the study. There were no significant differences between the two groups. CONCLUSION: The results of this trial suggest that GS-KG9 might be an effective and safe option for mild hepatic dysfunction. This trial is registered with KCT0004080. CI - Copyright (c) 2020 Lei Shen et al. FAU - Shen, Lei AU - Shen L AD - Department of Constitutional Medicine, College of Korean Medicine, Wonkwang University, Iksan 54538, Republic of Korea. FAU - Gwak, Si Ra AU - Gwak SR AD - Department of Constitutional Medicine, College of Korean Medicine, Wonkwang University, Iksan 54538, Republic of Korea. FAU - Joo, Jong Cheon AU - Joo JC AD - Department of Constitutional Medicine, College of Korean Medicine, Wonkwang University, Iksan 54538, Republic of Korea. FAU - Song, Bong Keun AU - Song BK AD - Department of Internal Medicine, College of Korean Medicine, Wonkwang University, Gwangju 51729, Republic of Korea. FAU - Cha, Seon Woo AU - Cha SW AD - International Ginseng and Herb Research Institute, Geumsan 32724, Republic of Korea. FAU - Song, Young Uk AU - Song YU AD - Daedong Korea Ginseng Co., Ltd., Geumsan 32718, Republic of Korea. FAU - Pyo, Mi Kyung AU - Pyo MK AUID- ORCID: 0000-0001-9229-3282 AD - International Ginseng and Herb Research Institute, Geumsan 32724, Republic of Korea. FAU - Park, Soo Jung AU - Park SJ AUID- ORCID: 0000-0001-8191-4290 AD - Department of Sasang Constitutional Medicine, College of Korean Medicine, Woosuk University, Jeonju 55338, Republic of Korea. LA - eng PT - Journal Article DEP - 20200716 PL - United States TA - Evid Based Complement Alternat Med JT - Evidence-based complementary and alternative medicine : eCAM JID - 101215021 PMC - PMC7381953 COIS- The authors declare that there are no conflicts of interest regarding the publication of this paper. EDAT- 2020/07/30 06:00 MHDA- 2020/07/30 06:01 PMCR- 2020/07/16 CRDT- 2020/07/30 06:00 PHST- 2020/01/29 00:00 [received] PHST- 2020/06/25 00:00 [accepted] PHST- 2020/07/30 06:00 [entrez] PHST- 2020/07/30 06:00 [pubmed] PHST- 2020/07/30 06:01 [medline] PHST- 2020/07/16 00:00 [pmc-release] AID - 10.1155/2020/2689565 [doi] PST - epublish SO - Evid Based Complement Alternat Med. 2020 Jul 16;2020:2689565. doi: 10.1155/2020/2689565. eCollection 2020.