Focus on Alternative and Complementary Therapies
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Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 2007; 12: 52
The aims of this trial were to document the safety and tolerability of two weight-based dosing schedules (standard dose vs. low dose vs. placebo); and to establish a preliminary estimate of the treatment effect of two doses of American ginseng (Panax quinquefolius) extract in reducing the severity and duration of upper respiratory tract infection (URTI) in children.
The study was a randomised, double-blind, dose-finding, three-arm trial (two dosing schedules of American ginseng extract, with one placebo control) during the winter months (November 2005 to March 2006) in children of 3–12 years of age.
Seventy-five children were pre-recruited from the general population in Edmonton, Alberta. Of these, 46 developed a URTI and were randomised (15 standard dose; 16 low dose; 15 placebo) (one withdrew 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 between the three treatment arms. Preliminary estimates of treatment effect were measured using a modified Canadian acute respiratory infection flu score (CARIFS). The survival time (until CARIFS dropped below one-quarter of the baseline score) demonstrated a non-significant difference (log-rank) at day 14 (P=0.694).
Standard doses of ginseng were well tolerated and merit further evaluation with regard to treatment of paediatric URTI.
SV receives salary support from the Alberta Heritage Foundation for Medical Research and Canadian Institutes of Health Research. BCJ holds a Sick Kids Foundation Duncan L. Gordon Fellowship. Study medication and funding was provided by CV Technologies Inc., Edmonton, Alberta, Canada. The formulation of ginseng used in the study (CVT-E002) is marketed as COLD-fX.
