Pomegranate Products for Prevention of Common Cold

Completed · Phase 3 · Has a placebo group

Conditions studied: Influenza, Common Cold, Cough, Headache, Fever

In brief

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 pomegranate polyphenols (primarily the ellagitannin punicalagin) and their health effects. A vast number of animal and human clinical studies have provided evidence on effect of pomegranate products on improving blood lipid profile, reducing blood pressure, improving endothelial function, anti-tumor activity, and its anti-atherosclerotic activity. We studied the protective effect of a pomegranate concentrate (POM Flu and Cold Formula®) in decreasing the incidence and duration of influenza-like illnesses and common cold among healthy adults.

Key facts

Study ID

NCT00617318

Run by

Texas Heart Institute

People needed

461

Starts

2007-01-01

Expected to finish

2007-06-01

Last updated by the study team

2008-02-18

Who can join

Age: 21 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Site 01 — San Diego, California, United States

Full record on ClinicalTrials.gov

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