The results of the double-blind, placebo-controlled study on the prevention and relief of upper respiratory infections will be published tomorrow. Edmonton, Alberta's Medical Officer of Health and a professor at the University of Alberta.conducted the clinical trial.
The number of upper respiratory infections in each subject was significantly reduced by 25% in the COLD-fX® group during the 4 month treatment period. Also, recurrent infections were reduced by 56% (10.0% in the COLD-fX® group v. 22.8% in the placebo group, an absolute difference of 12.8%). COLD-fX® treatment also had a significant effect in reducing the total symptom score and the duration of infections. The incidence of adverse events was low and the prevalence was found to be similar between the two groups.
The study involved 323 adults from the general population (18-65 years of age) with a history of at least two upper respiratory infections in the previous year. Participants were given either COLD-fX® or a placebo for four months during the winter of 2003/04. Subjects graded the severity and duration of their respiratory-related symptoms on a 4-point scale. All analysis was performed by a biostatistician under blinded conditions.
The authors of the study, Dr. Gerry Predy of the Capital Health in Edmonton and Dr. Tapan Basu of the University of Alberta, concluded that the COLD-fX® treatment appeared to be an attractive natural prophylactic treatment for upper respiratory infections. Regular intake of COLD-fX® was shown in the clinical trial to be effective not only for the prevention of upper respiratory infections, but also for relief of symptoms if an infection did occur. The results were similar to those observed in previous clinical studies on COLD-fX®. COLD-fX® is the result of research at the University of Alberta that developed into a spin-off company, CV Technologies Inc.
Dr. Basu said, "One of biggest challenges in clinical studies with natural based compounds is the lack of standardization of the testing material. Most natural health products do not offer batch-to-batch consistency and do not produce consistent clinical results. This trial was unique in that it examined a unique natural extract with the same rigor used for conducting trials of drug candidates in the pharmaceutical industry, a practice that is rarely found in the natural health product business."
"We are interested in the potential positive implications for our residents and the results from clinical trials done to date are encouraging" said Dr. Predy. "For example, in participants taking COLD-fX® daily for prevention, recurrent infections were reduced by more than half. In addition, there was a 31% reduction in the severity of their symptoms."
CV Technologies Inc. CEO and Chief Scientific Officer and co-discoverer of COLD-fX®, Dr. Jacqueline Shan said, "This is the first publicly known study to be completed under the new regulations established by Health Canada's Natural Health Product Directorate. We were pleased that the Canadian Medical Association Journal decided to publish the study. Like all published clinical trials it has undergone a rigorous peer-review process by experts chosen by the Journal."
In two previous trials involving 198 nursing home seniors conducted under FDA's drug regulations by Dr. Janet McElhaney, the newly appointed head of geriatric medicine at the University of British Columbia, COLD-fX® showed an 89% reduction in clinical illness caused by influenza and cold viral infection confirmed by virological testing. The four month study conducted while Dr. McElhaney was a professor at Eastern Virginia Medical School also demonstrated an excellent safety profile in that group. The results of that study were published in 2004 in the peer reviewed Journal of the American Geriatrics Society.
A multi-centre and multi-dosage, double-blind, placebo-controlled clinical trial on COLD-fX® involving 720 community living healthy seniors was launched this month in Canada. This trial is being jointly conducted by Dr. Gerry Predy, Medical Officer of Health in Edmonton, Dr. Andrew Simor, a leading infectious disease expert and the head of microbiology at Sunnybrook and Women's College Health Sciences Centre in Toronto and Dr. Janet McElhaney, an internationally recognized influenza expert and head of geriatric medicine at the University of British Columbia in Vancouver.
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