Dataset Information

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

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.

SUBMITTER: Carnevali I

PROVIDER: S-EPMC7798282 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Carnevali Ilaria I La Paglia Rita R Pauletto Lara L Raso Floriana F Testa Marco M Mannucci Carmen C Sorbara Emanuela Elisa EE Calapai Gioacchino G

BMC pediatrics 20210111 1

<h4>Background</h4>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.<h4>Methods</h4>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 ...[more]

PMID: 33430841

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Dataset Information

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

Background

Methods

Results

Conclusions

Trial registration

Publications

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

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