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).
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 106
- Locations
- 2
- Primary Endpoint
- Assessment of efficacy of treatment of cough persistent
Study Overview
Brief 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.
Detailed Description
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. Cough is perhaps the most troubling symptom for children suffering from upper respiratory tract infections (URIs) and their parents. Often It results in discomfort to the child and loss of sleep for both children and parents.
In the majority of cases, persistent cough is self-limiting, but its persistence could become exasperating and it could reduce quality of life and social activities.
The influence of persistent cough of children on family's life can create growing discomfort. Indeed, children with acute cough may experience transient disability which leads to lose parents' work and school days so increasing overall cost for its management. Generally, parents' concerns increase when children's cough lasts for more than a week. Consequently, often occurs that parents seek for a medical consult with requirement of drug treatment, even if the most of antitussive drugs lack of proved evidence of effectiveness and safety.
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. Epidemiological data indicate that cough in children is much more feared than in adults and a substantial proportion of individuals think of cough as "a disease". Also a recent Italian survey confirms this view by suggesting that some pediatricians' therapeutic attitudes should be substantially improved in order to achieve better management of cough in children and to minimize the burden of cough. Moreover, it often happens that attempting to treat cough, children are administered with over-the-counter products having little or no scientific evidence of proven efficacy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 3 Years to 6 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy children aged between 3 and 6 years, with persistent cough for at least three consecutive days.
Exclusion Criteria
- •Children with history of obstructive pulmonary diseases, cystic fibrosis, neuropathies, heart disease, diabetes and immunodeficiencies were excluded.
Arms & Interventions
KalobaTuss children
KalobaTuss children syrup 5 ml for 4 times a day supplied for 8 consecutive days.
Intervention: KalobaTuss children (Dietary Supplement)
Placebo
Placebo syrup 5 ml for 4 times a day supplied for 8 consecutive days.
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Assessment of efficacy of treatment of cough persistent
Time Frame: 8 weeks
Primary endpoint is the assessment of changes in day- and night-time cough score. Cough was diagnosed and evaluated by the pediatrician during the first visit and monitored by parents by filling a daily diary. At the end of the administration period pediatrician visited again children and collected the daily diary for each child.
Secondary Outcomes
No secondary outcomes reported
Investigators
Gioacchino Calapai
FULL PROFESSOR OF PHARMACOLOGY AND TOXICOLOGY
Azienda Ospedaliera Universitaria Policlinico "G. Martino"