Status:
COMPLETED
Pomegranate Products for Prevention of Common Cold
Lead Sponsor:
Texas Heart Institute
Collaborating Sponsors:
POM Wonderful LLC
Conditions:
Influenza
Common Cold
Eligibility:
All Genders
21-49 years
Phase:
PHASE3
Brief Summary
Pomegranate has a long history of use in folk medicine. There is vast data on the health benefits of pomegranate fruit and juice. Multiple studies have established the strong antioxidative effects of ...
Detailed Description
Pomegranate has a long history of use in folk medicine. Widely grown and consumed in most countries, pomegranate fruit and its products are now being produced and used more extensively in the US. The ...
Eligibility Criteria
Inclusion
- Subjects must meet all of the inclusion criteria in order to be eligible to participate in the study:
- Subject must be able to read and sign Informed Consent Form (ICF).
- Subject must be male or female \> 21 and \< 49 years of age at the time the ICF is signed.
- Subject must have made a personal decision NOT to receive influenza vaccine this season.
Exclusion
- A subject meeting any of the exclusion criteria at baseline will be excluded from study participation:
- Subject who has a known allergy to pomegranate and POM products. Subject who has an intercurrent infection and fever during the week before the investigational product administration is to begin.
- Subject who has experienced acute respiratory tract infection, otitis media, bronchitis or sinusitis, or who had been treated with an antiviral drug, systemic steroids, or immunosuppressants within two weeks of the Screening/Randomization Visit.
- Subject who has uncontrolled chronic medical disorders (e.g., subjects with evidence of evolving hepatic or renal failure, congestive heart failure Killip Class IV, or any terminal disease).
- Subject who reports HIV infection.
- Subject who abuses alcohol or other drugs of abuse.
- Subject who has clinical evidence of current malignancy.
- Female subject with positive pregnancy test, or who is sexually active and not using adequate contraception regularly, or who is a nursing mother.
- Subject who has taken other experimental products within one month prior to study entry.
- Subject who has any medical condition that may interfere with study protocol adherence.
- Subject has any disorder (excluding illiteracy or visual impairment) that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
- Subject who in the opinion of the study investigator has a risk of non-compliance with study procedures, or cannot read, understand or complete study related materials.
- Subject who has a foreseeable inability to complete the scheduled follow-ups.
- Subject who meets one or more of the criteria for influenza immunization according to the current CDC List of Priority Groups for Vaccination.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
461 Patients enrolled
Trial Details
Trial ID
NCT00617318
Start Date
January 1 2007
End Date
June 1 2007
Last Update
February 18 2008
Active Locations (1)
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1
Site 01
San Diego, California, United States, 92108