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Randomized Controlled Trial
. 2021 Jan 11;21(1):29.
doi: 10.1186/s12887-020-02490-2.

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

Ilaria Carnevali  1 , Rita La Paglia  2 , Lara Pauletto  1 , Floriana Raso  1 , Marco Testa  1 , Carmen Mannucci  3 , Emanuela Elisa Sorbara  3 , Gioacchino Calapai  4
Affiliations
Randomized Controlled Trial

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

Ilaria Carnevali et al. BMC Pediatr. .

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.

Keywords: Children; Cough; Helichrysum stoechas; Honey; Inula helenium; Malva sylvestris; Plantago major; Syrup.

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Conflict of interest statement

Authors Ilaria Carnevali, Lara Pauletto, Floriana Raso, Marco Testa, are employed by the company Schwabe Pharma Italia, Egna (BZ), Italy. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationship that could be construed as a potential conflict of interest.

Figures

Fig. 1
Fig. 1
Study Flowchart
Fig. 2
Fig. 2
Night-time or Day-time cough score before and after treatment with KalobaTUSS® or placebo. * = p < 0.05 vs placebo; * = p < 0.01 vs placebo
Fig. 3
Fig. 3
Reduction in night-time and day-time cough scores in children treated with KalobaTUSS® or Placebo. * = p < 0.01 vs Placebo
See this image and copyright information in PMC

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