Efficacy and Safety of Resveratrol and Carbossimetyl Beta Glucan in Treatment of Upper Airways Disease in Infancy

Study Overview
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Brief Summary
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outpatient infants (0-6 months of life), affected by symptoms of upper airways disease will be randomly assigned to two type of intervention: A: treatment group, receiving resveratrol and carbossimetyl beta glucan; B: control group, receiving saline solution. Each subject underwent clinical history, objective examination and detection of rinovirus in the nasal secretions at enrollment, after 48 hours and after 7 and 30 days.

Detailed Description
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Consecutive outpatient infants (0 - 6 months) with common cold symptoms were enrolled and randomly divided into two groups: resveratrol plus carboxymethyl-β-glucan solution or saline isotonic solution randomized treatment (3 drops in each nasal fossa, 4 time daily for seven days). Each patient underwent clinical evaluation at enrollment, after 48 hours and after 7 and 30 days. Common cold symptoms were specifically evaluated according to CARIFS Scale. Nasal swabs for HRV research will performed at enrollment, after 48 hours and after 7 and 30 days.

Official Title
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Efficacy and Safety of a New Medical Device Based on Resveratrol and Carbossimetyl Beta Glucan in Treatment of Upper Airways Disease in Infancy

Conditions
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Common Cold

Intervention / Treatment
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* Drug: Resveratrol and Carbossimetyl Beta Glucan
* Other: Saline Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: common cold syndrome Exclusion Criteria: main comorbidities

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resveratrol and Carbossimetyl Beta Glucan<br> | Drug: Resveratrol and Carbossimetyl Beta Glucan<br>* Medical device based on Resveratrol and Carbossimetyl Beta Glucan. 3 drops, 4 times a day for 1 week.<br>|
| Placebo Comparator: Saline solution<br> | Other: Saline Solution<br>* Medical device based on Saline Solution. 3 drops, 4 times a day for 1 week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Canadian Acute Respiratory Illness and Flu Scale (CARIFS) | The CARIFS score consisted of 18 items each answered on a 4-point scale (no problem = 0, minor problem = 1, moderate problem = 2, major problem = 3). Some CARIFS items such as headache, sore-throat, muscle aches or pains were not applicable to infants. The mean of the point of all applicable items was considered as a measure of child's overall illness level. | enrollment, after 48 hours and after 7 and 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of Rinovirus in the nasal secretions | Difference in Human Rhinovirus replication will by the use of nasal swab analysis. | after 48 hours and 7 days | 
| 30-day relapses | Number of relapses | 30-day after treatment |