Canadian Study Of Colds And Kids:
Positive Safety Results For Ginseng Extract
August 5, 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 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 three 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% to 45% 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 over 7,000
children under 12 are treated each year in U.S. hospital
emergency rooms for adverse drug reactions from cough and cold medications.
----------------------------
Article adapted by Medical News Today from original press
release.
----------------------------
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.
Pediatrics is the official journal of the American Academy of
Pediatrics and is recognized as the leading peer reviewed pediatrics
publication in the world. 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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