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

NCT01564849 | Unknown

• 1 other identifier: 89-2011
• Study Type: observational
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhinitis; Sinusitis; Nasal Polyps

Keywords

Pomegranate fruit extract; Sinusitis; rhinitis; nasal polyps

Study Arms (6)

chronic rhinitis,

chronic sinusitis

nasal polyps

control rhinitis

control sinusitis

control polyps

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults suffering from chronic rhinitis, sinusitis and nasal polyps

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hillel Yaffe Medical Center: lead
• Gan shmuel Group: collaborator

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, Pob 169, 38100, Israel

RECRUITING

MeSH Terms

Conditions

Rhinitis; Sinusitis; Nasal Polyps

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Itzhak Braverman, MD

CONTACT

972-4-630-4549; braverman@hy.health.gov.il

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Otolarungology Head and Neck Surgery Unit

Study Record Dates

• First Submitted: March 25, 2012
• First Posted: March 28, 2012
• Study Start: April 1, 2012
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: November 15, 2016

Record last verified: 2016-11

Locations

IL (1)