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

Phase 3

Completed

• Conditions: Common Cold
• Interventions: Drug: Resveratrol and Carbossimetyl Beta Glucan; Other: Saline Solution

• Registration Number: NCT03683108
• Lead Sponsor: Policlinico Hospital

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.

Study Timeline

• Study Start: 2015-12
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Study First Submitted: 2018-03-07
• Study First Submitted QC: 2018-09-21
• Study First Posted: 2018-09-25
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-18
• Last Update Posted: 2019-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• common cold syndrome

Exclusion Criteria

• main comorbidities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resveratrol and Carbossimetyl Beta Glucan	Resveratrol and Carbossimetyl Beta Glucan	-
Saline solution	Saline Solution	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital; 🇮🇹 Bari, Italy