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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Hillel Yaffe Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Gan Shmuel Food LTD. Kibbutz Gan Shmuel. POB HEFER 30010.
Information provided by:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01564849
First received: March 25, 2012
Last updated: March 27, 2012
Last verified: March 2012
  Purpose

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
Rhinitis
Sinusitis
Nasal Polyps

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hillel Yaffe Medical Center:

Estimated Enrollment: 198
Study Start Date: April 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
chronic rhinitis,
chronic sinusitis
nasal polyps
control rhinitis
control sinusitis
control polyps

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults suffering from chronic rhinitis, sinusitis and nasal polyps

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01564849

Contacts
Contact: Itzhak Braverman, MD 972-4-630-4549 braverman@hy.health.gov.il

Locations
Israel
Hillel Yaffe Medical Center Not yet recruiting
Hadera, Pob 169, Israel, 38100
Sponsors and Collaborators
Hillel Yaffe Medical Center
Gan Shmuel Food LTD. Kibbutz Gan Shmuel. POB HEFER 30010.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01564849     History of Changes
Other Study ID Numbers: 89-2011
Study First Received: March 25, 2012
Last Updated: March 27, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Hillel Yaffe Medical Center:
Pomegranate fruit extract
Sinusitis
rhinitis
nasal polyps

Additional relevant MeSH terms:
Rhinitis
Polyps
Sinusitis
Nasal Polyps
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Pathological Conditions, Anatomical
Paranasal Sinus Diseases

ClinicalTrials.gov processed this record on October 01, 2014