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

NCT ID: NCT03683108

Last Updated: 2019-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2018-03-31

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.

Conditions

Common Cold

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Resveratrol and Carbossimetyl Beta Glucan

Group Type: EXPERIMENTAL

Resveratrol and Carbossimetyl Beta Glucan

Intervention Type: DRUG

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

Saline solution

Group Type: PLACEBO_COMPARATOR

Saline Solution

Intervention Type: OTHER

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

Interventions

Resveratrol and Carbossimetyl Beta Glucan

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

Intervention Type: DRUG

Saline Solution

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• common cold syndrome

Exclusion Criteria

• main comorbidities

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Policlinico Hospital

OTHER

Sponsor Role: lead

Responsible Party

Prof. Maria Elisabetta Baldassarre

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Bari, , Italy

Countries

Italy

Other Identifiers

VIRNEO1

Identifier Type: -

Identifier Source: org_study_id