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Completed

NCT Number: NCT03683108

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

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.

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Key information

Conditions

Common Cold Infections Picornaviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

1 day–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Bari, 70124, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • common cold syndrome

Exclusion criteria

  • main comorbidities

Treatment and study plan

Resveratrol and Carbossimetyl Beta Glucan

Drug

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

Saline solution

Other

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

Primary outcomes

  1. Canadian Acute Respiratory Illness and Flu Scale (CARIFS)

    Time frame: 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 outcomes

  1. Detection of Rinovirus in the nasal secretions

    Time frame: after 48 hours and 7 days

    Difference in Human Rhinovirus replication will by the use of nasal swab analysis.

  2. 30-day relapses

    Time frame: 30-day after treatment

    Number of relapses

Sponsors and collaborators

Lead sponsor

Policlinico Hospital

Other

Registry information

Official study title

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

Acronym: VIRNEO

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 25, 2018
Registry last updated
Mar 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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