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Efficacy, Safety and Palatability of the Syrup "KalobaTuss® Children" for the Treatment of Cough in Children

NCT04073251 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2019-08-29

No results posted yet for this study

Summary

Cough of children is one of the most frequent events for which parents ask for a medical consult and it is a true challenge for pediatrics during daily practice.

In the majority of cases, it is self-limiting, but its persistence could become exasperating and it could reduce quality of life and social activities.

Even if inappropriate prescription of antitussive pharmacological treatment in children has been reduced, pediatrics prescribing attitudes do not still always are reflecting accurate treatment of cough.

Furthermore, pediatric approach is always compromised by parental exaggerate perception of symptoms and usual consequent requirement of pharmacological prescription of antibiotics, that they consider the appropriate and effective therapeutic option for cough.

The World Health Organization identifies honey as a potential demulcent treatment for cough.

On the light of the above considerations and since available pediatric treatments for acute cough are limited by lack of demonstrated efficacy, a pediatric cough syrup product containing Acacia honey as well as specific fractions of resins, polysaccharides, saponins, flavonoids and sugars derived from Malva sylvestris extract, Inula helenium, Plantago major extract, Helichrysum stoechas (KalobaTuss) was developed to be clinically tested on persisting cough of children. Investigators evaluated through a randomized, double blind controlled clinical study the effects of KalobaTuss on persistent cough in children aging 3-6 years. The effects of Kalobatuss were compared with effects of placebo on nocturnal and daytime persistent cough for eight days. Objective of the study was to evaluate the clinical efficacy of KalobaTuss by using as primary endpoint the assessment of changes in day- and night-time cough score.

Conditions

Interventions

DIETARY_SUPPLEMENT

KalobaTuss children

Syrup, dosage: 5 ml for 4 times a day for 8 days.

DIETARY_SUPPLEMENT

Placebo

Syrup, dosage: 5 ml for 4 times a day for 8 days.

Sponsors & Collaborators

  • Azienda Ospedaliera Universitaria Policlinico "G. Martino"

    lead OTHER

Principal Investigators

  • Gioacchino Calapai, MD · Azienda Ospedaliera Universitaria "G Martino", Messina, Italy.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-15
Primary Completion
2019-05-03
Completion
2019-05-10

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04073251 on ClinicalTrials.gov