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Research article
Efficacy and Safety of the Syrup "KalobaTUSS®" as a Treatment for Cough in Children: a randomized, double blind, placebo-controlled clinical trial
Gioacchino Calapai
Universita degli Studi di Messina
Corresponding Author
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at BMC Pediatrics.
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.
Keywords
Syrup, cough, children, honey, Malva sylvestris, Inula helenium, Plantago, Helichrysum stoechas
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CURRENT STATUS: Published
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Posted 11 Jan, 2021
Published
On 11 Jan, 2021
No community comments so far
Submission checks complete
On 30 Dec, 2020
Editorial decision: Accept
On 28 Dec, 2020
No comments provided
Editorial decision: Minor revision
On 14 Dec, 2020
Editor assigned
On 03 Dec, 2020
Submission checks complete
On 03 Dec, 2020
Editor invited
On 03 Dec, 2020
No comments provided
Reviewer #2 agreed
On 20 Nov, 2020
Review #2 received
Received 20 Nov, 2020
Editorial decision: Minor revision
On 20 Nov, 2020
Review #1 received
Received 15 Nov, 2020
Reviewer #1 agreed
On 05 Nov, 2020
Reviewers invited
Invitations sent on 04 Nov, 2020
Editor assigned
On 29 Oct, 2020
Submission checks complete
On 28 Oct, 2020
Editor invited
On 28 Oct, 2020
Community comments: 2
Review #3 received
Received 19 Sep, 2020
Editorial decision: Major revision
On 19 Sep, 2020
Review #2 received
Received 04 Sep, 2020
Reviewer #3 agreed
On 02 Sep, 2020
Review #1 received
Received 18 Aug, 2020
Reviewer #2 agreed
On 07 Aug, 2020
Reviewers invited
Invitations sent on 07 Jul, 2020
Reviewer #1 agreed
On 07 Jul, 2020
Editor assigned
On 24 Jun, 2020
First submitted
On 23 Jun, 2020
Submission checks complete
On 23 Jun, 2020
Editor invited
On 23 Jun, 2020
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Subject Areas
Pediatrics
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This preprint is under consideration at BMC Pediatrics. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research article
Efficacy and Safety of the Syrup "KalobaTUSS®" as a Treatment for Cough in Children: a randomized, double blind, placebo-controlled clinical trial
Gioacchino Calapai
Universita degli Studi di Messina
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Version 4
Posted 11 Jan, 2021
Published
On 11 Jan, 2021
No community comments so far
Submission checks complete
On 30 Dec, 2020
Editorial decision: Accept
On 28 Dec, 2020
No comments provided
Editorial decision: Minor revision
On 14 Dec, 2020
Editor assigned
On 03 Dec, 2020
Submission checks complete
On 03 Dec, 2020
Editor invited
On 03 Dec, 2020
No comments provided
Reviewer #2 agreed
On 20 Nov, 2020
Review #2 received
Received 20 Nov, 2020
Editorial decision: Minor revision
On 20 Nov, 2020
Review #1 received
Received 15 Nov, 2020
Reviewer #1 agreed
On 05 Nov, 2020
Reviewers invited
Invitations sent on 04 Nov, 2020
Editor assigned
On 29 Oct, 2020
Submission checks complete
On 28 Oct, 2020
Editor invited
On 28 Oct, 2020
Community comments: 2
Review #3 received
Received 19 Sep, 2020
Editorial decision: Major revision
On 19 Sep, 2020
Review #2 received
Received 04 Sep, 2020
Reviewer #3 agreed
On 02 Sep, 2020
Review #1 received
Received 18 Aug, 2020
Reviewer #2 agreed
On 07 Aug, 2020
Reviewers invited
Invitations sent on 07 Jul, 2020
Reviewer #1 agreed
On 07 Jul, 2020
Editor assigned
On 24 Jun, 2020
First submitted
On 23 Jun, 2020
Submission checks complete
On 23 Jun, 2020
Editor invited
On 23 Jun, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Pediatrics
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at BMC Pediatrics.
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