Indication: Upper respiratory tract infections (URTIs or URIs); safety and tolerability of formulation


Source: Pediatrics, August 2008; 122(2):e402-10.

Research: A randomized, double-blind, placebo-controlled Canadian trial was conducted to measure the safety and tolerability of Cold-fX in children. Seventy-five children aged 3 to 12 years were recruited for the winter of 2005-2006. Forty-six of these children developed an upper respiratory infection, so within 48 hours of onset they were randomly given either a placebo or American ginseng at two different dosage levels for three days.

Results: There were no serious adverse events reported and the ginseng was well tolerated. FDA and Health Canada are investigating the safety and efficacy of children’s cold remedies. The re­searchers believe the safety and tolerability of North American ginseng merits additional evaluation in the treatment of URTIs in children.