A Phase II Biomarker Trial of Gelatin Encapsulated Extract of American Ginseng Root (LEAG) in Breast Cancer
Asian ginseng (Panax ginseng) and its close relative American ginseng (Panax quinquefolium)
are perennial aromatic herbs that are widely used in Asian medicine. Ginseng root is used
as a tonic thought to increase the body's resistance to stress and fatigue, to increase
endurance under heavy physical activity, and to improve well-being in age-related
debilitation. Most of the ginseng consumed, even in Asian populations, is American ginseng,
and the majority of American ginseng is grown and processed in Wisconsin, with quality and
standardization overseen by the Ginseng Board of Wisconsin. Furthermore, in Asian medicine,
Asian ginseng (Panax ginseng) and American ginseng (Panax quinquefolium) are common
components in herbals used for cancer prevention and treatment. Indeed, retrospective
studies have shown that patients who consumed ginseng on a regular basis experienced cancers
at a reduced rate, however, breast cancer was not considered. Ginseng has been used
medicinally for over 2000 years and there are no substantiated serious adverse effects, and
few, if any, non-serious adverse effects. The World Health Organization lists ginseng as a
traditional medicine with very low toxicity. Clinical trials have also demonstrated an
anti-hyperglycemic action of American ginseng. These studies utilized capsules containing
dried, ground Ontario-grown P. qinquefolius L. root. The ground AG root preparation had an
onset of action of 40 minutes. They found no significant increase in anti-hyperglycemic
action after 40 minutes and no significant increase in anti-hyperglycemic action using 1
gram versus 3 gram dosing.
LEAG is a standardized preparation of lyophilized water-extract of American ginseng root in
250-mg gelatin capsules. The ginseng was purchased through the Ginseng Board of Wisconsin
and the lyophilized extract has been certified for percentage of each and total ginsenoside
content and screened for safe levels of minerals, metals, and pesticides by ConsumerLab.com,
a leading testing service company of dietary supplements.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proliferation and Cytotoxicity Markers
24 months
Yes
Elizabeth Peralta, M.D.
Study Chair
Sutter Health
United States: Food and Drug Administration
PER-SCCI 07-001.1
NCT00631852
February 2008
March 2016
Name | Location |
---|---|
Simmons Cancer Institute-SIU School of Medicine | Springfield, Illinois 62702 |