Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00655031
Other study ID # A004
Secondary ID
Status Completed
Phase Phase 2
First received April 4, 2008
Last updated August 14, 2008
Start date April 2008
Est. completion date July 2008

Study information

Verified date August 2008
Source POM Wonderful LLC
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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 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 reducing symptoms of common cold, reducing blood pressure, improving endothelial function, anti-tumor activity, and its anti-atherosclerotic activity. This study will evaluate the protective effect of a pomegranate concentrate (POMx) in decreasing the incidence and duration of the common cold among healthy adults.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date July 2008
Est. primary completion date May 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Nonsmoker

- No recent history of respiratory disease

Exclusion Criteria:

- Serum positive for rhinovirus

- Pregnant or breastfeeding

- Recent immunization

Study Design

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


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Pomegranate Concentrate (POMx)
3.3 oz bottle containing antioxidants equivalent to 8 oz of pomegranate juice taken once daily for 7 days prior to infection and for 4 days after.
Placebo
3.3 oz bottle containing fruit flavored juice low in antioxidants taken once daily for 7 days prior to infection and for 4 days after.

Locations

Country Name City State
United States University of Virginia School of Medicine Charlottesville Virginia
United States Accelovance Inc. Huntsville Alabama
United States Accelovance Inc Melbourne Florida

Sponsors (1)

Lead Sponsor Collaborator
POM Wonderful LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Days 1-5 No
Secondary Comparison of symptom scores in the treatment groups Days 1-5 No
Secondary Determination of effects of treatment on immune function. Days 1-5 No
See also
  Status Clinical Trial Phase
Completed NCT05269290 - Efficacy and Safety of Ingavirin®, Syrup, 30 mg/5 ml, in Children With Influenza and Other Acute Respiratory Viral Infections Phase 3
Completed NCT02451163 - DBRCT on the Effect of Wheat Polysaccharides on Common Cold Infections in Elderly Phase 2
Completed NCT01944631 - Iota-Carrageenan Nasal Spray in Common Cold Phase 4
Completed NCT01651715 - Efficacy and Safety Study of Homeopathic Oral Antibodies to Treat Viral Upper Respiratory Tract Infections Phase 1/Phase 2
Completed NCT00963443 - Acetylsalicylic Acid Combined With Pseudoephedrine in Common Cold Phase 3
Completed NCT00778648 - Encapsulated Juice Powder Concentrate for Preventing Common Cold Symptoms N/A
Completed NCT00065715 - Echinacea Versus Placebo Effect in Common Cold (Physician Echinacea Placebo) Phase 3
Completed NCT00032500 - Evaluation of Echinacea for the Common Cold Phase 2
Not yet recruiting NCT05070650 - Efficacy and Safety of the Combination of Acetylcysteine, Paracetamol and Phenylephrine for the Treatment of Common Cold Phase 3
Completed NCT04144491 - Effect of L. Rhamnosus Yoba on RTI and Other Health Outcomes Among Children (3-6 Years) in Uganda N/A
Not yet recruiting NCT04073511 - Herbal Medicine 'Eungyosan' and 'Samsoeum' for Common Cold N/A
Completed NCT03189537 - Study of Post-Exposure Ingavirin® Prophylaxis of Influenza and Acute Respiratory Viral Infections Phase 3
Terminated NCT01964885 - Benefit and Tolerability of IQP-AS-105 in Reducing Susceptibility to Upper Respiratory Tract Infections Phase 3
Completed NCT01277081 - Effect of Paracetamol on the Common Cold Phase 2
Completed NCT01728090 - Effectiveness of a Handwashing Programme in the Prevention of School Absenteeism Due to Respiratory Infections Phase 4
Completed NCT00405509 - The Natural History of Viral Upper Respiratory Infections in Children Aged 6 to Less Than 14 Years N/A
Completed NCT01033526 - Symptomatic Treatment of Common Cold Symptoms Phase 4
Completed NCT05556148 - Otrivine: Quality of Life (QoL) Impact in a Real-World Setting Phase 4
Terminated NCT03339726 - Randomized, Double-blind, Placebo-Controlled, Efficacy Study of a New Formulation of Phenylephrine HCL in the Common Cold Phase 2
Completed NCT01361399 - Active and Placebo Controlled Study to Test the Efficacy and Safety of an Aspirin-Lidocaine Lozenge in the Symptomatic Treatment of Sore Throat Associated With a Common Cold Phase 3