Cough
Conditions
Keywords
Pediatric, children, acute cough, treatment, syrup, protective natural extracts
Brief summary
The present clinical trial will examine the use of ABO/MEG-B-09 syrup in children with acute cough as compared to a placebo syrup.
Detailed description
Subjects will be asked to take 4 doses of 5 ml containing a mixture of honey and other natural ingredients or a placebo syrup everyday, during 8 days. The following outcomes will be noted down in a diary: occurence and severity of diurnal and nocturnal cough events (cough score) and symptoms, impediment of normal life activities (school, sleeping), the number of medical visits and type of medication needed if any.
Interventions
DEVICEAboMeg-B-09
Syrup: AboMeg-B-09 5ml to be taken 4 times a day during the entire study period
OTHERPlacebo
Placebo syrup: 5ml to be taken 4 times a day during the entire study period
Sponsors
Sprim Advanced Life Sciences
Aboca Spa Societa' Agricola
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* Children aged between 3 and 6 * Acute cough - lasting 1-3 weeks * Written informed consent by the parents/legal tutors * Parents/legal tutors must be willing not to give to the child other medications or products for the treatment of cough during the study period, unless they become clinically indicated in which case a rescue regimen can be administered and the child will be withdrawn from the study * Parents/legal tutors must be willing to comply with the study protocol
Exclusion criteria
* Children treated with immunostimulators and immune regulating drugs during the last month before starting the study * Children with immunodeficiencies or immune suppression * Children with chronic diseases - Pulmonary Diseases, Renal insufficiency, Heart diseases * Children treated with antibiotics, including prophylactic treatment * Children being treated with systemic corticosteroids - including oral aerosol inhaler * Children with potential immunosuppressive viral diseases - Measles, Chickenpox, Rubella, Infectious mononucleosis - within the last month * Children who have participated in previous studies with experimental products within the last month * Children with asthma or suspected diagnosis of asthma * Children with bacterial diseases - Pneumonia, Sepsis * Children with diabetes because of the high content of sugar of the study products - ABO/MEG-B-09 and placebo * Children allergic to any study product ingredients * Children/Parents/legal tutors with psychological condition that may, in the investigator's opinion, adversely affect their co-operation with the study protocol - syrup administration or compilation of the diary
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cough score variation | Measured at Baseline Visit (day 0) and at the Last Visit (day 8) | Clinical diurnal and nocturnal cough score (Chung) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cough reflex sensitivity | Measured at Baseline Visit (day 0) and at the Last Visit (day 8) | Capsaicin test - Cough Reflex Index (CRI) - |
| Objective breath sounds | Measured at Baseline Visit (day 0) and at the Last Visit (day 8) | Wheezometer test |
| The ventilation of the various pulmonary zones | Measured at Baseline Visit (day 0) and at the Last Visit (day 8) | Vibration Response Imaging (VRI) xp test |
| Quality of life | Measured at Baseline Visit (day 0) and at the Last Visit (day 8) | Quality of life questionnaire (QoL) |
Countries
Italy
Outcome results
None listed