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

January 15, 2019 updated by: BioHealth Technologies Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Hialeah, Florida, United States, 33010
        • Sunflower Preschool & Day Care
      • Miami, Florida, United States, 33125
        • Sunflower Preschool Childcare
      • Miami, Florida, United States, 33125
        • Sunflowers Academy
      • Miami, Florida, United States, 33135
        • Sunflowers Academy
      • Miami, Florida, United States, 33135
        • Sunflowers Preschool Childcare
      • Miami Beach, Florida, United States, 33141
        • Mt Sinai Day Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PrevinC
PrevinC contains isopropyl alcohol, sesame oil, aloe vera oil extract, and lemon oil.
Other: PrevinC
PLACEBO_COMPARATOR: Control solution
The control solution (distilled water and lemon oil) was similar in color, oily consistency and odor to that of PrevinC.
Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rhinitis
Time Frame: weekly from February 2005 to May 2005, up to 3 months
The incidence of rhinitis was measured on a weekly basis through evaluation of study diaries.
weekly from February 2005 to May 2005, up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioHealth Technologies Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (ACTUAL)

May 1, 2005

Study Completion (ACTUAL)

May 1, 2005

Study Registration Dates

First Submitted

August 23, 2014

First Submitted That Met QC Criteria

August 25, 2014

First Posted (ESTIMATE)

August 26, 2014

Study Record Updates

Last Update Posted (ACTUAL)

January 16, 2019

Last Update Submitted That Met QC Criteria

January 15, 2019

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Previn-C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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