Canadian Study of Colds and Kids Reveals Positive Safety Results for Ginseng Extract

[Guest guest]

Canadian Study of Colds and Kids Reveals Positive Safety Results for

Ginseng Extract

08/04/2008

Positive findings of a safety study involving children and a highly

touted botanical extract (COLD-fX) show promise for its future

development for kids as a Canadian cold and flu remedy. The results

appear in the August, 2008 issue of Pediatrics, the official journal of

the American Academy of Pediatrics.

The randomized, double-blind, placebo controlled Canadian trial which

was conducted in collaboration with the University of Alberta in Canada

was designed to measure the safety and tolerability of COLD-fX for

treatment of cold and flu in children. Acute three-day doses of COLD-fX

were well tolerated with no serious adverse events, or differences in

adverse events versus the placebo group. The research was also

successful in determining effect size, which enables appropriate

statistical planning of a potential efficacy study.

" We hope this trial will be viewed as timely and beneficial research in

an area where there is clearly a demonstrated need for safe and

effective products to treat cold and flu in children, who suffer from

these ailments much more than adults, " said Shan PhD, DSc,

chief scientific officer and CEO of CV Technologies. She added, " These

results are promising and support the development of a children's

formulation. " The Company anticipates launching large scale clinical

studies in the next fiscal year testing for efficacy to further support

the use of COLD-fX for treating colds and flu in children.

Seventy-five children between the ages of 3 and 12 were recruited in

Edmonton, Canada for the study, which was conducted in the winter of

2005-2006. Of those children, 46 developed an upper respiratory tract

infection (URTI). Within 48 hours of onset, they were randomly assigned

to receive acute three-day treatments with either a placebo or COLD-fX

(two weight-based dosage levels).

This is the first time COLD-fX has been studied for pediatric use. The

researchers report that they could find only seven other studies of

natural health products (NHPs) for children as of 2007. They indicated

that the lack of studies of this nature is " especially concerning "

given that " current estimates suggest that 41 percent to 45 percent of

children in Canada and the United States use NHPs. " .

COLD-fX, a patented extract of North American ginseng, discovered by a

team of 25 University of Alberta scientists, is Canada's top selling

cold and flu remedy for adults. It has been approved by Health Canada

for use by adults. And the FDA has cleared its sale as a new dietary

ingredient (NDI) for adults in the U. S.

The results of the trial come at a time when the FDA and Health Canada

are reviewing the safety and efficacy of hundreds of children's cough

and cold remedies sold in both countries. A study by the Centers for

Disease Control and Prevention (CDC) says more than 7,000 children

under 12 are treated each year in U.S. hospital emergency rooms for

adverse drug reactions from cough and cold medications.

The trial was approved by Health Canada and the University of Alberta

Ethics Committee and conducted by pediatric researchers in the Faculty

of Medicine at the University of Alberta, Edmonton, Canada. The results

were first presented at two major scientific conferences in the UK and

Canada.