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

Policlinico Hospital

Status and phase: Completed; Phase 3

Conditions: Common Cold

Treatments: Drug: Resveratrol and Carbossimetyl Beta Glucan; Other: Saline Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03683108

VIRNEO1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 1 day to 6 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• common cold syndrome

Exclusion criteria

• main comorbidities

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Resveratrol and Carbossimetyl Beta Glucan

Experimental group

Treatment:

Drug: Resveratrol and Carbossimetyl Beta Glucan

Saline solution

Placebo Comparator group

Treatment:

Other: Saline Solution