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A Placebo Controlled, Randomized, Double Blind Pilot Study to Evaluate the Use of Pomegranate Concentrate (POMx) for the Prevention of Experimental Rhinovirus Infection in Human Subjects


Phase 2
18 Years
45 Years
Not Enrolling
Both
Common Cold

Thank you

Trial Information

A Placebo Controlled, Randomized, Double Blind Pilot Study to Evaluate the Use of Pomegranate Concentrate (POMx) for the Prevention of Experimental Rhinovirus Infection in Human Subjects


Inclusion Criteria:



- Nonsmoker

- No recent history of respiratory disease

Exclusion Criteria:

- Serum positive for rhinovirus

- Pregnant or breastfeeding

- Recent immunization

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

The proportion of subjects who become infected in the active treatment group compared with the proportion of subjects who become infected in the placebo treatment group.

Outcome Time Frame:

Days 1-5

Safety Issue:

No

Principal Investigator

Ronald B Turner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Virginia

Authority:

United States: Institutional Review Board

Study ID:

A004

NCT ID:

NCT00655031

Start Date:

April 2008

Completion Date:

July 2008

Related Keywords:

  • Common Cold
  • Punicaceae
  • Pomegranate
  • Common Cold

Name

Location
Accelovance Inc. Huntsville, Alabama  35802
Accelovance Inc Melbourne, Florida  32935
University of Virginia School of Medicine Charlottesville, Virginia  22908