Efficacy and Safety of the Syrup "KalobaTUSS®" as a Treatment for Cough in Children: a randomized, double blind, placebo-controlled clinical trial
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 eight 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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Posted 11 Jan, 2021
On 11 Jan, 2021
On 30 Dec, 2020
On 28 Dec, 2020
On 14 Dec, 2020
On 03 Dec, 2020
On 03 Dec, 2020
On 03 Dec, 2020
On 20 Nov, 2020
Received 20 Nov, 2020
On 20 Nov, 2020
Received 15 Nov, 2020
On 05 Nov, 2020
Invitations sent on 04 Nov, 2020
On 29 Oct, 2020
On 28 Oct, 2020
On 28 Oct, 2020
Received 19 Sep, 2020
On 19 Sep, 2020
Received 04 Sep, 2020
On 02 Sep, 2020
Received 18 Aug, 2020
On 07 Aug, 2020
Invitations sent on 07 Jul, 2020
On 07 Jul, 2020
On 24 Jun, 2020
On 23 Jun, 2020
On 23 Jun, 2020
On 23 Jun, 2020
Efficacy and Safety of the Syrup "KalobaTUSS®" as a Treatment for Cough in Children: a randomized, double blind, placebo-controlled clinical trial
Posted 11 Jan, 2021
On 11 Jan, 2021
On 30 Dec, 2020
On 28 Dec, 2020
On 14 Dec, 2020
On 03 Dec, 2020
On 03 Dec, 2020
On 03 Dec, 2020
On 20 Nov, 2020
Received 20 Nov, 2020
On 20 Nov, 2020
Received 15 Nov, 2020
On 05 Nov, 2020
Invitations sent on 04 Nov, 2020
On 29 Oct, 2020
On 28 Oct, 2020
On 28 Oct, 2020
Received 19 Sep, 2020
On 19 Sep, 2020
Received 04 Sep, 2020
On 02 Sep, 2020
Received 18 Aug, 2020
On 07 Aug, 2020
Invitations sent on 07 Jul, 2020
On 07 Jul, 2020
On 24 Jun, 2020
On 23 Jun, 2020
On 23 Jun, 2020
On 23 Jun, 2020
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 eight 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.
Figure 1
Figure 2
Figure 3