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Positive findings of a safety study involving children and a highly touted botanical distil (COLD-fX) show up promise for its future development for kids as a Canadian cold and flu therapeutic. 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 intentional to measure the safety and tolerability of COLD-fX for discourse of cold and flu in children. Acute three-day doses of COLD-fX were well tolerated with no serious inauspicious events, or differences in adverse events versus the placebo grouping. The research was likewise successful in determining effect size, which enables reserve statistical provision of a potential efficacy study.
"We promise this trial will be viewed as timely and beneficial research in an area where there is clearly a demonstrated need for safe and efficacious products to treat frigid and influenza in children, who suffer from these ailments a lot 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 scurf clinical studies in the next financial year testing for efficacy to further support the use of COLD-fX for treating colds and influenza in children.
Seventy-five children between the ages of three and 12 were recruited in Edmonton, Canada for the written report, which was conducted in the wintertime of 2005-2006. Of those children, 46 developed an upper respiratory tract infection (URTI). Within 48 hours of onset, they were randomly assigned to welcome acute three-day treatments with either a placebo or COLD-fX (2 weight-based dose levels).
This is the first gear time COLD-fX has been studied for pediatric use. The researchers report that they could find only when seven other studies of natural wellness products (NHPs) for children as of 2007. They indicated that the deficiency of studies of this nature is "especially concerning" given that "current estimates suggest that 41% to 45% of children in Canada and the United States enjoyment NHPs".
COLD-fX, a patented extract of North American ginseng, discovered by a team of 25 University of Alberta scientists, is Canada's top merchandising 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 over 7,000 children under 12 are treated each year in U.S. hospital emergency rooms for adverse do drugs 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 low presented at two major scientific conferences in the UK and Canada.
Pediatrics is the official journal of the American Academy of Pediatrics and is accepted as the leading peer reviewed pedology publication in the reality. It is printed in four languages with a circulation of nearly 80,000 copies. It began publishing in 1948.
Source:
Warren Michaels
CV Technologies Inc.
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