The G115 Standardized Ginseng Extract: An Example for Safety, Efficacy, and Quality of an Herbal Medicine

J Ginseng Res. 2020 Mar;44(2):179-193. doi: 10.1016/j.jgr.2019.06.003. Epub 2019 Jun 18.

Abstract

Ginseng products on the market show high variability in their composition and overall quality. This becomes a challenge for both consumers and health-care professionals who are in search of high-quality, reliable ginseng products that have a proven safety and efficacy profile. The botanical extract standardization is of crucial importance in this context as it determines the reproducibility of the quality of the product that is essential for the evaluation of effectiveness and safety. This review focuses on the well-characterized and standardized ginseng extract, G115, which represents an excellent example of an herbal drug preparation with constant safety and efficacy within the herbal medicinal products. Over the many decades, extensive preclinical and clinical research has been conducted to evaluate the efficacy and safety of G115. In vitro and in vivo studies of G115 have shown pharmacological effects on physical performance, cognitive function, metabolism, and the immune system. Furthermore, a significant number of G115 clinical studies, most of them double-blind placebo-controlled, have reinforced the findings of preclinical evidence and proved the efficacy of this extract on blood glucose and lipid regulation, chronic obstructive pulmonary disease, energy, physical performance, and immune and cognitive functions. Clinical trials and 50 years of presence on the market are proof of a good safety profile of G115.

Keywords: 3′,5′-AMP, adenosine 3′5′ monophosphate; AMPK, 5′ AMP-activated protein kinase; ATP, adenosine triphosphate; Blood glucose and lipid regulation; CDR, cognitive drug research; CDRI, cognitive drug research index; CO, crossover; COPD, chronic obstructive pulmonary disease; Chronic obstructive pulmonary disease; DB, double-blind; DER, drug extract ratio; Energy and physical performance; FBG, fasting blood glucose; FEF50, forced expiratory flow50; FEF75, forced expiratory flow75; FER, forced expiratory ratio; FEV1, forced expiration volume in one second; FEV1/FVC, ratio of FEV1/FVC; FVC, forced vital capacity; G115 standardized ginseng extract; G115, standardized root extract of P. ginseng Meyer; GACPs, good agricultural and collection practices; GMPs, good manufacturing practices; HDL-c, high-density lipoprotein; HMPs, herbal medicinal products; HbAlc, glycated hemoglobin; Immune and cognitive functions; LA, lipoic acid; LDLc, low-density lipoprotein; MVV, maximum ventilation volume; PC, placebo-controlled; PEF, peak expiration flow; PEFR, peak expiration flow rate; PFTs, pulmonary function tests; PG, parallel group; PGC-1α, proliferator-activated receptor gamma coactivator-1α; PS, pilot study; PaO2, blood oxygen pressure; R, randomized; RVIP, rapid visual information processing; S-SIgA, SIgA secretion rate; SB, single-blind; SFR, saliva flow rate; SIRT1, sirtuin 1; SIgA, secretory immunoglobulin A; TC, total cholesterol; TG, triglyceride; VLDL, very-low-density lipoprotein; VO2 max, maximal oxygen consumption; WHO, World Health Organization; pO2, partial oxygen pressure.

Publication types

  • Review