Common Cold
Conditions
Brief summary
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
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.
Interventions
OTHERSaline Solution
Medical device based on Saline Solution. 3 drops, 4 times a day for 1 week.
DRUGResveratrol and Carbossimetyl Beta Glucan
Medical device based on Resveratrol and Carbossimetyl Beta Glucan. 3 drops, 4 times a day for 1 week.
Sponsors
Policlinico Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 6 Months
Healthy volunteers
Yes
Inclusion criteria
* common cold syndrome
Exclusion criteria
* main comorbidities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Canadian Acute Respiratory Illness and Flu Scale (CARIFS) | enrollment, after 48 hours and after 7 and 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detection of Rinovirus in the nasal secretions | after 48 hours and 7 days | Difference in Human Rhinovirus replication will by the use of nasal swab analysis. |
| 30-day relapses | 30-day after treatment | Number of relapses |
Countries
Italy
Outcome results
None listed