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 Jacqueline 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.