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

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ClinicalTrials.gov Identifier: NCT04073251
Recruitment Status : Completed
First Posted : August 29, 2019
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
Gioacchino Calapai, Azienda Ospedaliera Universitaria Policlinico "G. Martino"

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.


Condition or disease Intervention/treatment Phase
Cough Dietary Supplement: KalobaTuss children Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind controlled clinical study .
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: 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).
Actual Study Start Date : February 15, 2019
Actual Primary Completion Date : May 3, 2019
Actual Study Completion Date : May 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arm Intervention/treatment
Experimental: KalobaTuss children
KalobaTuss children syrup 5 ml for 4 times a day supplied for 8 consecutive days.
Dietary Supplement: KalobaTuss children
Syrup, dosage: 5 ml for 4 times a day for 8 days.

Placebo Comparator: Placebo
Placebo syrup 5 ml for 4 times a day supplied for 8 consecutive days.
Dietary Supplement: Placebo
Syrup, dosage: 5 ml for 4 times a day for 8 days.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04073251


Locations
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Italy
Gioacchino Calapai
Messina, Me, Italy, 98125
Sponsors and Collaborators
Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Investigators
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Principal Investigator: Gioacchino Calapai, MD Azienda Ospedaliera Universitaria "G Martino", Messina, Italy.
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gioacchino Calapai, FULL PROFESSOR OF PHARMACOLOGY AND TOXICOLOGY, Azienda Ospedaliera Universitaria Policlinico "G. Martino"
ClinicalTrials.gov Identifier: NCT04073251    
Other Study ID Numbers: KTC
First Posted: August 29, 2019    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gioacchino Calapai, Azienda Ospedaliera Universitaria Policlinico "G. Martino":
Persistent cough
Children
Additional relevant MeSH terms:
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Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory