A Study to Evaluate the Efficacy of the Nasal Antiseptic, PrevinC, When Administered for the RiskReduction of Rhinitis in Subjects Who Work for Child Day Care Centers

NCT ID: NCT02225912

Last Updated: 2019-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2005-05-31

Brief Summary

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The hypothesis was to establish whether the use of PrevinC administered nasally 2-3 times a day will prevent upper respiratory infections in otherwise healthy adults working in child day care centers.

Detailed Description

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Conditions

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Upper Respiratory Infections

Study Design

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Intervention Model

CROSSOVER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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PrevinC

PrevinC contains isopropyl alcohol, sesame oil, aloe vera oil extract, and lemon oil.

Group Type EXPERIMENTAL

PrevinC

Intervention Type OTHER

Control solution

The control solution (distilled water and lemon oil) was similar in color, oily consistency and odor to that of PrevinC.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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PrevinC

Intervention Type OTHER

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subject must provide written informed consent prior to the conduct of any study
* Male or female
* 18-65 years of age
* Inclusive
* Employed by one of seven selected Day Care Centers

Exclusion Criteria

* Recent symptoms of upper respiratory infection, respiratory disease
* Received medication for colds or allergies within 3 weeks of enrolling
* Had nasal surgery within 2 months of enrolling
* Had a pierced nose or wore nose jewelry
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BioHealth Technologies Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sunflower Preschool & Day Care

Hialeah, Florida, United States

Site Status

Sunflower Preschool Childcare

Miami, Florida, United States

Site Status

Sunflowers Academy

Miami, Florida, United States

Site Status

Sunflowers Academy

Miami, Florida, United States

Site Status

Sunflowers Preschool Childcare

Miami, Florida, United States

Site Status

Mt Sinai Day Care

Miami Beach, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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Previn-C

Identifier Type: -

Identifier Source: org_study_id

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