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Online Journal of Pharmacology and PharmacoKinetics ©
Volume 5: 32-43, 2009
Pilot Clinical Study on a Proprietary Elderberry Extract: Efficacy in Addressing Influenza Symptoms
Fan-kun Kong, PhD.
Trial conducted by Medical Personnel at
Kong F, Pilot Clinical Study on a Proprietary Elderberry Extract: Efficacy in Addressing Influenza Symptoms, Online J Pharmacol Pharmacokin 5:32-42, 2009. Elderberry (Sambucus nigra L.) has a long history of being used in treating colds and influenza. A proprietary standardized elderberry extract has been formulated into a slow-dissolve lozenge. A pilot, randomized, double-blind, placebo-controlled clinical trial was conducted during the spring flu season of 2009 to evaluate the efficacy of the extract in relieving flu-like symptoms. Sixty-four patients with three or more flu-like symptoms (fever, headache, muscle aches, coughing, nasal mucus discharge, and nasal congestion) for less than 24 hours were enrolled in the study. The patients were randomized into two groups and given 4 doses of 175 mg of the proprietary elderberry extract per dose (n=32) or a placebo (n=32) daily for two days. The severity of symptoms was self-monitored by the patients and scored on a Visual Analogue Scale (VAS), with “0” equal to no problem and “10” equal to a pronounced problem. The extract treated group showed significant improvement in most of the symptoms except 24 hours after the onset of the treatment, whereas the placebo group showed no improvement or an increase in severity of the symptoms at the same time point. By 48 hours, 9 patients (28%) in the extract treated group were void of all symptoms, 19 patients (60%) showed relief from some symptoms, and had only one or two mild symptoms (VAS=1). The remaining 4 patients also showed symptoms improvement but to a lesser degree. In contrast, complete recovery was not achieved by a single patient in the placebo group. Only 5 patients (16%) showed improvement in one or two symptoms. For most patients in this group, the symptoms remained the same or even worsened over the 48-hour monitoring period. No adverse effects were observed in either group indicating that the proprietary elderberry extract is safe and highly effective in treating flu-like symptoms.
Key words: proprietary elderberry extract, clinical trial, influenza, flu-like symptoms