First NHP-approved trial launched on Cold-FX
clinical trial complying with Health Canada's new natural health
product regulations, introduced in January.
The product, Cold-FX made by Canada's CV Technologies, has already completed phase 2 clinical trials involving seniors in five US nursing homes, which found it to reduce the risk of getting a cold or flu by 89 per cent. Results were published in the January 2004 edition of the Journal of the American Geriatric Society.
The new NHP regulations require formal double blind, placebo-controlled clinical trial results to support medical claims for a natural health product.
The new study will be the eighth carried out on the remedy and will assess whether acute and short term use of Cold-FX can shorten the severity and duration of colds in a cross section of the population. It will recruit 600 people, starting this week.
"Both the industry and consumers have been waiting for the new regulations to be implemented. This is a great step forward which will allow consumers to know which products meet the new standards for safety, efficacy and consistency and which don't and which are in the process of doing so," said CV Technologies president, CEO and chief scientific officer Dr Jacqueline Shan.
The 7th preventative trial on the product was launched in the fall of 2003, with results expected later this year.
Estimates suggest colds and flu hit around 4 million Canadians each year.
