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

Common Cold Clinical Trial

— VIRNEO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03683108
• Other study ID #: VIRNEO1
• Status: Completed
• Phase: Phase 3
• Start date: December 2015
• Est. completion date: March 2018

Study information

• Verified date: March 2019
• Source: Policlinico Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

• common cold syndrome

Exclusion Criteria:

• main comorbidities

Related Conditions & MeSH terms

• Common Cold

Intervention

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.

Locations

Country	Name	City	State
Italy	Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital	Bari

Sponsors (1)

Lead Sponsor	Collaborator
Policlinico Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	30-day relapses	Number of relapses	30-day after treatment