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This monograph covers the published and unpublished scientific and clinical research on CVT-E002 (COLD-fX®), a proprietary herbal preparation made from the roots of North American ginseng (Panax quinquefolius L., Araliaceae). Because CVT-E002 is a chemically distinct fraction (a group of chemically similar compounds, in this case polysaccharides) made from American ginseng roots (see Description and Chemistry sections below), it has pharmacological properties different from less homogeneous extract preparations made from the root of American ginseng, aka North American ginseng. Accordingly, most of the ethnobotanical, pharmacological, toxicological, and clinical literature on American ginseng root is not applicable to this monograph, and with perhaps a few exceptions, will not be cited herein.

Various species of “ginseng” from the genus Panax that have been employed in systems of traditional and folkloric medicine have undergone various levels of modern scientific research—some moderate, some extensive. For example, the famous Asian ginseng (P. ginseng C.A. Meyer), aka Chinese ginseng and Korean ginseng, depending on its geographical origin, has been the focus of significant scientific and clinical study for the past 30–40 years in Asia and Europe. Other species in the genus Panax (e.g., P. japonicus C.A. Meyer and P. notoginseng [Burkill] F.H. Chen ex C.Y. Wu & K.M. Feng) have been studied to a lesser extent. From a research perspective, American ginseng has lagged behind these other species, except for a cluster of recent clinical trials conducted in the past 6 years that focused on the blood sugar modulating effects of American ginseng root powder in normal, healthy individuals as well as those with type 2 diabetes.1,2,3

To date, the vast majority of chemical, pharmacological (in vitro and in vivo) and toxicological research on American ginseng root has focused on the ginsenosides, a group of saponin glycosides that are characteristic of the ginsengs, being found in no other plant species except Gynostemma pentaphyllum [Thunb.] Makino (Curcurbitaceae).4 In addition to the ginsenosides, chemical analyses have determined the presence of various polysaccharides (see Chemistry section below).5,6,7

In vitro and in vivo pharmacological research studies have determined that these polysaccharides exhibit various immunomodulatory effects.5,6,8,9 In 1992, the late Peter Pang, PhD, and Jacqueline Shan, PhD, DSc, co-founders of CV Technologies, began the development of a phytomedicinal preparation comprised of polysaccharides from American ginseng roots.10 Their research culminated in the production and patenting of CVT-E002,11 the proprietary preparation that is the subject of this monograph.