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

Overview

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.

Full Title of Study: “Efficacy and Safety of a New Medical Device Based on Resveratrol and Carbossimetyl Beta Glucan in Treatment of Upper Airways Disease in Infancy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2018

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Resveratrol and Carbossimetyl Beta Glucan
  • Placebo Comparator: Saline solution

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
  • 30-day relapses
    • Time Frame: 30-day after treatment
    • Number of relapses

Participating in This Clinical Trial

Inclusion Criteria

  • common cold syndrome Exclusion Criteria:

  • main comorbidities

Gender Eligibility: All

Minimum Age: 1 Day

Maximum Age: 6 Months

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Policlinico Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Prof. Maria Elisabetta Baldassarre, Researcher – Policlinico Hospital

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.