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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
102
Syrup: AboMeg-B-09 5ml to be taken 4 times a day during the entire study period
Placebo syrup: 5ml to be taken 4 times a day during the entire study period
Santa Maria della Misercordia di Udine Hospital
Udine, Udine, Italy
Cough score variation
Clinical diurnal and nocturnal cough score (Chung)
Time frame: Measured at Baseline Visit (day 0) and at the Last Visit (day 8)
Cough reflex sensitivity
Capsaicin test - Cough Reflex Index (CRI) -
Time frame: Measured at Baseline Visit (day 0) and at the Last Visit (day 8)
Objective breath sounds
Wheezometer test
Time frame: Measured at Baseline Visit (day 0) and at the Last Visit (day 8)
The ventilation of the various pulmonary zones
Vibration Response Imaging (VRI) xp test
Time frame: Measured at Baseline Visit (day 0) and at the Last Visit (day 8)
Quality of life
Quality of life questionnaire (QoL)
Time frame: Measured at Baseline Visit (day 0) and at the Last Visit (day 8)
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