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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resveratrol and Carbossimetyl Beta Glucan | Experimental |
| |
| Saline solution | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resveratrol and Carbossimetyl Beta Glucan | Drug | Medical device based on Resveratrol and Carbossimetyl Beta Glucan. 3 drops, 4 times a day for 1 week. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital | Bari | 70124 | Italy |
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| ID | Term |
|---|---|
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D000077185 | Resveratrol |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000081225 | Stilbestrols |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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| Saline Solution | Other | Medical device based on Saline Solution. 3 drops, 4 times a day for 1 week. |
|
| 30-day after treatment |
| D014777 |
| Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D059808 | Polyphenols |
| D010636 | Phenols |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |