Safety and tolerability of North American ginseng extract in the treatment of pediatric upper respiratory tract infection: a phase II randomized, controlled trial of 2 dosing schedules.
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BACKGROUND: Upper respiratory tract infections are the most common childhood illness. Panax quinquefolius (American ginseng root extract) standardized to contain 80% poly-furanosyl-pyranosyl-saccharides is purported to be effective in adult upper respiratory tract infection but has not been evaluated yet in a pediatric population. OBJECTIVES: Our primary objective was to document the safety and tolerability of 2 weight-based dosing schedules (standard dose versus low dose versus placebo) in children. We also used the Canadian Acute Respiratory Infection Flu Scale, a quantitative scoring sheet for measuring the severity and duration of upper respiratory symptoms, to establish the SD of the treatment effect to allow sample-size calculations for future clinical trials. METHODS: We conducted a randomized, double-blind dose-finding 3-arm trial (2 dosing schedules of American ginseng extract with 1 placebo control) during the winter months (November 2005 to March 2006) in children 3 to 12 years of age. RESULTS: Seventy-five subjects were prerecruited from the general population in Edmonton. Of these, 46 subjects developed an upper respiratory tract infection and were randomly assigned (15 standard dose, 16 low dose, and 15 placebo), with 1 subject withdrawing from the low-dose arm before beginning the intervention. No serious adverse events were reported. The frequency, severity, and degree of association between the intervention and reported adverse events were not significantly different among each of the 3 treatment arms. CONCLUSIONS: Standard doses of ginseng were well tolerated and merit additional evaluation with regard to treatment of pediatric upper respiratory tract infection.