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The Clinical Efficacy of Topical Nasal Pomegranate Fruit Extract for Patients With Chronic Rhinosinusitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01564849
Recruitment Status : Unknown
Verified November 2016 by Itzhak Braverman, Hillel Yaffe Medical Center.
Recruitment status was:  Recruiting
First Posted : March 28, 2012
Last Update Posted : November 15, 2016
Gan shmuel Group
Information provided by (Responsible Party):
Itzhak Braverman, Hillel Yaffe Medical Center

Brief Summary:

An explosion of interest in the numerous therapeutic properties of Punica granatum over the last decade has led to numerous in vitro, animal, and clinical trials. Pomegranate is a potent antioxidant, superior to red wine and equal to or better than green tea. In addition, anticarcinogenic and anti-inflammatory properties suggest its possible use as a therapy or adjunct for prevention and treatment of several types of cancer and cardiovascular disease. Because of pomegranate's antimicrobial properties, it may aid in preventing infection by dental pathogens, pathogenic E. coli O157:H7, and antibiotic-resistant organisms such as methicillin-resistant Staphylococcus aureus (MRSA) Pomegranate's effect on bacterial pathogens has only been tested in vitro, however, necessitating human trials to refute or substantiate any clinical effect.

The possibility that pomegranate extracts may also have an effect on several other disease processes, such as Alzheimer's and obesity, underscores the need for more clinical research. Currently, numerous clinical trials are in progress exploring the therapeutic potential of pomegranate extracts.

Aim The investigators want to evaluate the effect of Punica granatum components on Chronic sinusitis, nasal polyps and chronic rhinitis.

Condition or disease
Rhinitis Sinusitis Nasal Polyps

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Study Type : Observational
Estimated Enrollment : 198 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Clinical Efficacy of Topical Nasal Pomegranate Fruit Extract (PFE) for Patients With Chronic Rhinitis, Chronic Sinusitis With or Without Nasal Polyps
Study Start Date : April 2012
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis

chronic rhinitis,
chronic sinusitis
nasal polyps
control rhinitis
control sinusitis
control polyps

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults suffering from chronic rhinitis, sinusitis and nasal polyps

Inclusion Criteria:

  • above age 18
  • under age 80
  • patients with chronic rhinitis, sinusitis and nasal polyps
  • patients candidates for surgery or medical therapy

Exclusion Criteria:

  • Patients that had nasal surgery before
  • smokers
  • Diabetes, chemotherapy or radiation therapy
  • Allergy to yeasts or pomegranate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01564849

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Contact: Itzhak Braverman, MD 972-4-630-4549

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Hillel Yaffe Medical Center Recruiting
Hadera, Pob 169, Israel, 38100
Contact: Ahud Sternberg, MD   
Sponsors and Collaborators
Hillel Yaffe Medical Center
Gan shmuel Group

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Responsible Party: Itzhak Braverman, Head Otolarungology Head and Neck Surgery Unit, Hillel Yaffe Medical Center Identifier: NCT01564849    
Other Study ID Numbers: 89-2011
First Posted: March 28, 2012    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016
Keywords provided by Itzhak Braverman, Hillel Yaffe Medical Center:
Pomegranate fruit extract
nasal polyps
Additional relevant MeSH terms:
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Nasal Polyps
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Pathological Conditions, Anatomical
Paranasal Sinus Diseases