COLD-fX, a natural treatment derived from the North American ginseng plant, reduces the occurrence and the severity of upper respiratory infections, new research suggests.

The results are slated for publication in the Canadian Medical Association Journal.

COLD-fX is a patented highly purified natural product obtained from roots of North American ginseng, says CV Technologies. Each capsule contains 200 mg of dried extract, CVT-E002, which has been shown in laboratory and clinical studies to strengthen the immune system, the company notes.

Infections, Symptoms Reduced

Dr. Gerry Predy of the Capital Health in Edmonton and Dr. Tapan Basu of the University of Alberta conducted the double-blind, placebo-controlled study on the prevention and relief of upper respiratory infections.

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 number of upper respiratory infections in each subject was significantly reduced by 25% in the COLD-fX group during the four-month treatment period. 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%).

In addition, COLD-fX treatment 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 COLD-fX treatment appeared to be an attractive natural prophylactic treatment for upper respiratory infections, the authors concluded.

Rigorous Clinical Trial

"One of biggest challenges in clinical studies with natural based compounds is the lack of standardization of the testing material," says Dr. Basu.

"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," Dr. Basu comments.

"We are interested in the potential positive implications for our residents and the results from clinical trials done to date are encouraging," adds 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," Dr. Predy points out.

"We were pleased that the Canadian Medical Association Journal decided to publish the study," says COLD-fX co-discoverer Dr. Jacqueline Shan, CV Technologies Inc. CEO and Chief Scientific Officer. "Like all published clinical trials, it has undergone a rigorous peer-review process by experts chosen by the Journal."

Additional Research

In two previous trials involving 198 nursing home seniors, COLD-fX showed an 89% reduction in clinical illness caused by influenza and cold viral infection confirmed by virological testing.

Dr. Janet McElhaney, the newly appointed head of geriatric medicine at the University of British Columbia, conducted the research.

A multi-center and multi-dosage, double-blind, placebo-controlled clinical trial on COLD-fX involving 720 healthy community-living seniors was launched this month in Canada.

This trial is being conducted by Dr. Predy, Dr. Janet McElhaney and Dr. Andrew Simor, a leading infectious disease expert and the head of microbiology at Sunnybrook and Women's College Health Sciences Centre in Toronto.