NCT03683108

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Policlinico Hospital · Academic / Other
• Sex: All
• Age: 1 Day – 6 Months
• Healthy volunteers: Accepted

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.

Conditions

• Common Cold

Interventions

Type	Name	Description
DRUG	Resveratrol and Carbossimetyl Beta Glucan	Medical device based on Resveratrol and Carbossimetyl Beta Glucan. 3 drops, 4 times a day for 1 week.
OTHER	Saline Solution	Medical device based on Saline Solution. 3 drops, 4 times a day for 1 week.

Timeline

• Start date: 2015-12-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2018-09-25
• Last updated: 2019-03-20

Locations

1 site across 1 country: Italy