Evidence map›Paper›PMID 33430841›Full record

Trial reportBMC pediatrics2021

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

Ilaria Carnevali, Rita La Paglia, Lara Pauletto, Floriana Raso, Marco Testa, Carmen Mannucci, Emanuela Elisa Sorbara, Gioacchino Calapai

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC pediatrics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04073251 (Randomized, Controlled, Double Blind Clinical Study on the Assessment of Efficacy, Safety and Palatability of "KalobaTuss® Children", a Syrup for the Treatment of Cough in Pediatric Age), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04073251 nacompletednot on this map

Randomized, Controlled, Double Blind Clinical Study on the Assessment of Efficacy, Safety and Palatability of "KalobaTuss® Children", a Syrup for the Treatment of Cough in Pediatric Age (3-6 Years).

TypeinterventionalSponsorAzienda Ospedaliera Universitaria Policlinico "G. Martino"Ran2019 to 2019Enrolled106ConditionsCoughArmsKalobaTuss children, Placebo
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

  1. Honey for acute cough in children - a systematic review.European journal of pediatrics · 2023
    Pooled it
  2. Article
  3. Article
  4. Review
  5. Effect ofCaspian journal of internal medicine · 2024
    Article
  6. Involvement of NO/cGMP Signaling Pathway, CaInternational journal of molecular sciences · 2022
    Article
  7. Review
  8. Article
  9. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

Ilaria CarnevaliScientific Affairs Department Schwabe Pharma Italia, Egna, BZ, Italy.
Rita La PagliaPediatrician, Azienda Sanitaria Provinciale 5, Messina, Italy.
Lara PaulettoScientific Affairs Department Schwabe Pharma Italia, Egna, BZ, Italy.
Floriana RasoScientific Affairs Department Schwabe Pharma Italia, Egna, BZ, Italy.
Marco TestaScientific Affairs Department Schwabe Pharma Italia, Egna, BZ, Italy.
Carmen MannucciDepartment of Biomedical, Dental, Morphological and Functional Imaging Sciences, University of Messina, Via Consolare Valeria n 1, 98125, Messina, Italy.
Emanuela Elisa SorbaraDepartment of Biomedical, Dental, Morphological and Functional Imaging Sciences, University of Messina, Via Consolare Valeria n 1, 98125, Messina, Italy.
Gioacchino CalapaiDepartment of Biomedical, Dental, Morphological and Functional Imaging Sciences, University of Messina, Via Consolare Valeria n 1, 98125, Messina, Italy. gcalapai@unime.it.
University of Messina · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAcute 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.

methodsWe 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.

resultsChildren 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.

conclusionsKalobaTUSS® is well tolerated and produces positive effects by reducing the severity and shortening the duration of cough in children.

trial registrationClinicaltrials.gov no. NCT04073251 . Retrospectively registered.

Indexed as

CoughQuality of LifeAdministration, OralChildDouble-Blind MethodHumansChildrenCoughHelichrysum stoechasHoneyInula heleniumMalva sylvestrisPlantago majorSyrup

Identifiers

PMID33430841
PMCPMC7798282
OpenAlexW3111430274

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.