Effectiveness and Safety of Panax ginseng Extract on Hepatic Dysfunction: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

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 subj...

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Main Authors: Lei Shen, Si Ra Gwak, Jong Cheon Joo, Bong Keun Song, Seon Woo Cha, Young Uk Song, Mi Kyung Pyo, Soo Jung Park
Format: Article
Language:English
Published: Hindawi Limited 2020-01-01
Series:Evidence-Based Complementary and Alternative Medicine
Online Access:http://dx.doi.org/10.1155/2020/2689565
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spelling doaj-cc2a5159c80f4b358303bdc6c93bf4e92020-11-25T03:02:27ZengHindawi LimitedEvidence-Based Complementary and Alternative Medicine1741-427X1741-42882020-01-01202010.1155/2020/26895652689565Effectiveness and Safety of Panax ginseng Extract on Hepatic Dysfunction: A Randomized, Double-Blind, Placebo-Controlled Clinical TrialLei Shen0Si Ra Gwak1Jong Cheon Joo2Bong Keun Song3Seon Woo Cha4Young Uk Song5Mi Kyung Pyo6Soo Jung Park7Department of Constitutional Medicine, College of Korean Medicine, Wonkwang University, Iksan 54538, Republic of KoreaDepartment of Constitutional Medicine, College of Korean Medicine, Wonkwang University, Iksan 54538, Republic of KoreaDepartment of Constitutional Medicine, College of Korean Medicine, Wonkwang University, Iksan 54538, Republic of KoreaDepartment of Internal Medicine, College of Korean Medicine, Wonkwang University, Gwangju 51729, Republic of KoreaInternational Ginseng and Herb Research Institute, Geumsan 32724, Republic of KoreaDaedong Korea Ginseng Co., Ltd., Geumsan 32718, Republic of KoreaInternational Ginseng and Herb Research Institute, Geumsan 32724, Republic of KoreaDepartment of Sasang Constitutional Medicine, College of Korean Medicine, Woosuk University, Jeonju 55338, Republic of KoreaBackground. 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.http://dx.doi.org/10.1155/2020/2689565
collection DOAJ
language English
format Article
sources DOAJ
author Lei Shen
Si Ra Gwak
Jong Cheon Joo
Bong Keun Song
Seon Woo Cha
Young Uk Song
Mi Kyung Pyo
Soo Jung Park
spellingShingle Lei Shen
Si Ra Gwak
Jong Cheon Joo
Bong Keun Song
Seon Woo Cha
Young Uk Song
Mi Kyung Pyo
Soo Jung Park
Effectiveness and Safety of Panax ginseng Extract on Hepatic Dysfunction: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Evidence-Based Complementary and Alternative Medicine
author_facet Lei Shen
Si Ra Gwak
Jong Cheon Joo
Bong Keun Song
Seon Woo Cha
Young Uk Song
Mi Kyung Pyo
Soo Jung Park
author_sort Lei Shen
title Effectiveness and Safety of Panax ginseng Extract on Hepatic Dysfunction: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
title_short Effectiveness and Safety of Panax ginseng Extract on Hepatic Dysfunction: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
title_full Effectiveness and Safety of Panax ginseng Extract on Hepatic Dysfunction: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
title_fullStr Effectiveness and Safety of Panax ginseng Extract on Hepatic Dysfunction: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
title_full_unstemmed Effectiveness and Safety of Panax ginseng Extract on Hepatic Dysfunction: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
title_sort effectiveness and safety of panax ginseng extract on hepatic dysfunction: a randomized, double-blind, placebo-controlled clinical trial
publisher Hindawi Limited
series Evidence-Based Complementary and Alternative Medicine
issn 1741-427X
1741-4288
publishDate 2020-01-01
description 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.
url http://dx.doi.org/10.1155/2020/2689565
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