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Efficacy and safety of the syrup “KalobaTUSS®” as a treatment for cough in children: a randomized, double blind, placebo-controlled clinical trial

Ilaria Carnevali, Rita La Paglia, Lara Pauletto, Floriana Raso, Marco Testa, Carmen Mannucci, Emanuela Elisa Sorbara,
Published: 11 January 2021

Abstract: Background: Acute cough in children often causes discomfort to children and parents, reducing their quality of life. Despite the extensive utilization of over-the-counter remedies for cough, the efficacy of most of these treatments in children has not been confirmed. Methods: We conducted a randomized, double blind, placebo-controlled clinical trial of 106 children with acute cough to evaluate the efficacy and safety of KalobaTUSS®, a paediatric cough syrup based on acacia honey and on Malva sylvestris extract, Inula helenium extract, Plantago major extract, and Helichrysum stoechas extract by using a validated 6 points Likert scale. Results: Children were orally treated with KalobaTUSS® or placebo for 8 days. Children receiving KalobaTUSS® showed an early and significant reduction in night-time and day-time cough scores measured using a specific scale and a shorter duration of cough than children treated with the placebo. Conclusions: KalobaTUSS® is well tolerated and produces positive effects by reducing the severity and shortening the duration of cough in children. Trial registration: no. NCT04073251. Retrospectively registered.
Keywords: Syrup / Cough / Children / Honey / Malva sylvestris / Inula helenium / Plantago major / Helichrysum stoechas
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