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

Lei Shen; Si Ra Gwak; Jong Cheon Joo; Bong Keun Song; Seon Woo Cha; Young Uk Song; Mi Kyung Pyo; Soo Jung Park

doi:10.1155/2020/2689565

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

Evid Based Complement Alternat Med. 2020 Jul 16:2020:2689565. doi: 10.1155/2020/2689565. eCollection 2020.

Authors

Lei Shen¹, Si Ra Gwak¹, Jong Cheon Joo¹, Bong Keun Song², Seon Woo Cha³, Young Uk Song⁴, Mi Kyung Pyo³, Soo Jung Park⁵

Affiliations

¹ Department of Constitutional Medicine, College of Korean Medicine, Wonkwang University, Iksan 54538, Republic of Korea.
² Department of Internal Medicine, College of Korean Medicine, Wonkwang University, Gwangju 51729, Republic of Korea.
³ International Ginseng and Herb Research Institute, Geumsan 32724, Republic of Korea.
⁴ Daedong Korea Ginseng Co., Ltd., Geumsan 32718, Republic of Korea.
⁵ Department of Sasang Constitutional Medicine, College of Korean Medicine, Woosuk University, Jeonju 55338, Republic of Korea.

Abstract

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.