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

NCT03683108 | Completed Phase 3

• 1 other identifier: VIRNEO1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Common Cold

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Detection of Rinovirus in the nasal secretions

  after 48 hours and 7 days

• 30-day relapses

  30-day after treatment

Study Arms (2)

Resveratrol and Carbossimetyl Beta Glucan

EXPERIMENTAL

Drug: Resveratrol and Carbossimetyl Beta Glucan

Saline solution

PLACEBO COMPARATOR

Other: Saline Solution

Interventions

Resveratrol and Carbossimetyl Beta Glucan DRUG

Medical device based on Resveratrol and Carbossimetyl Beta Glucan. 3 drops, 4 times a day for 1 week.

Resveratrol and Carbossimetyl Beta Glucan

Saline Solution OTHER

Medical device based on Saline Solution. 3 drops, 4 times a day for 1 week.

Saline solution

Eligibility Criteria

• Age: 1 Day - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• common cold syndrome

You may not qualify if:

• main comorbidities

Sponsors & Collaborators

• Policlinico Hospital: lead

Study Sites (1)

Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital

Bari, 70124, Italy

Location

MeSH Terms

Conditions

Common Cold

Interventions

Resveratrol; Saline Solution

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: September 25, 2018
• Study Start: December 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: March 20, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)