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

Autor: Ilaria Carnevali, Rita La Paglia, Lara Pauletto, Floriana Raso, Marco Testa, Carmen Mannucci, Emanuela Elisa Sorbara, Gioacchino Calapai
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: BMC Pediatrics, Vol 21, Iss 1, Pp 1-9 (2021)
Druh dokumentu: article
ISSN: 1471-2431
DOI: 10.1186/s12887-020-02490-2
Popis: 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 Clinicaltrials.gov no. NCT04073251 . Retrospectively registered.
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