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Manuka Honey Nasal Rinse Study

This study has been withdrawn prior to enrollment.
(Funding withdrawn.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02097576
First Posted: March 27, 2014
Last Update Posted: July 18, 2014
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.
Collaborators:
NeilMed Pharmaceuticals
Wedderspoon USA
Information provided by (Responsible Party):
University of Florida
  Purpose

The purpose of this study is to evaluate whether high-volume nasal rinses with a manuka honey/saline mixture will improve symptom scores, nasal endoscopic findings and CT scan findings compared to nasal saline rinse without manuka honey in patients with chronic rhinosinusitis.

Manuka honey is a honey made from bees that drink the nectar from tea (manuka) trees in New Zealand. It has been shown to have antibacterial activity against common bacteria that cause chronic sinusitis.


Condition Intervention
Rhinosinusitis Other: Saline mixed with Manuka Honey Other: NeilMed Saline Sinus Rinse

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Manuka Honey/Saline Nasal Rinses as an Adjunct to Standard Medical Therapy for Chronic Rhinosinusitis: A Prospective Clinical Trial

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Change in SNOT-22 Symptomatic Scores at 1 month [ Time Frame: Change from baseline at 1 month ]
    There are 22 questions, each scored 0 - 5. Possible scores are 0 - 110. The best score is 0, the worst score is 110.

  • Change in SNOT-22 Symptomatic Scores at 3 months [ Time Frame: Change from baseline at 3 months ]
    There are 22 questions, each scored 0 - 5. Possible scores are 0 - 110. The best score is 0, the worst score is 110.

  • Change in SNOT-22 Symptomatic Scores at 6 months [ Time Frame: Change from baseline at 6 months ]
    There are 22 questions, each scored 0 - 5. Possible scores are 0 - 110. The best score is 0, the worst score is 110.


Secondary Outcome Measures:
  • Change in Endoscopic Scores of CRS severity in the different treatment arms at 1 month [ Time Frame: Change in baseline at 1 month ]
  • Change in Endoscopic Scores of CRS severity in the different treatment arms at 3 months [ Time Frame: Change in baseline at 3 months ]
  • Change in Endoscopic Scores of CRS severity in the different treatment arms at 6 months [ Time Frame: Change in baseline at 6 months ]
  • Change in Radiologic Scores of CRS severity in the different treatment arms at 3 months [ Time Frame: Change in baseline at 3 months ]

Enrollment: 0
Study Start Date: May 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NeilMed Saline Sinus Rinse
Saline nasal rinses will be performed using a NeilMed® Sinus Rinse 240 ml bottle and one NeilMed® packet containing sodium chloride/sodium bicarbonate at a concentration to make an isotonic solution when mixed with distilled or previously boiled water.
Other: NeilMed Saline Sinus Rinse
Saline nasal rinses will be performed using a NeilMed® Sinus Rinse 240 ml bottle and one NeilMed® packet containing sodium chloride/sodium bicarbonate at a concentration to make an isotonic solution when mixed with distilled or previously boiled water.
Active Comparator: Saline mixed with Manuka Honey
Saline mixed with MH nasal rinses participants will be instructed how to mix a rounded teaspoon of MH (Wedderspoon® 100% Raw Manuka Honey Active 16+) with 4-6 oz of lukewarm distilled or previously boiled water, to add along with distilled or previously boiled water and the NeilMed® Sinus Rinse packet to the rinse bottle to a final volume of 240 ml. Participants will be instructed to rinse slowly with the MH/saline rinse mixture to maximize contact time with the MH/saline mixture.
Other: Saline mixed with Manuka Honey
Saline mixed with MH nasal rinses participants will be instructed how to mix a rounded teaspoon of MH (Wedderspoon® 100% Raw Manuka Honey Active 16+) with 4-6 oz of lukewarm distilled or previously boiled water, to add along with distilled or previously boiled water and the NeilMed® Sinus Rinse packet to the rinse bottle to a final volume of 240 ml. Participants will be instructed to rinse slowly with the MH/saline rinse mixture to maximize contact time with the MH/saline mixture.
Other Names:
  • NeilMed® Sinus Rinse
  • Manuka Honey

Detailed Description:
If the subject chooses to participate in the study, the subject will be asked to fill out a symptom questionnaire at the beginning of the study and at each follow-up visit. The subject will be randomly assigned (much like the flip of a coin) to one of two treatment arms in addition to the prescribed medical treatments: 1) nasal rinses twice daily with a saline solution (standard therapy) or 2) nasal rinses with a saline solution mixed with manuka honey (the experimental therapy.) Subjects in the manuka honey/saline rinse arm will perform the experimental rinses twice daily for one month, and then will continue with saline rinses twice daily, with manuka honey added to the rinses only as needed. Nasal rinsing of some kind will be continued through the entire study period.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic Rhinosinusitis
  • Nasal Polyposis stages 1-3

Exclusion Criteria:

  • Nasal Polyposis stage 4-5
  • Cystic Fibrosis
  • Immunocompromised patients
  • Allergy to bees or honey
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02097576


Sponsors and Collaborators
University of Florida
NeilMed Pharmaceuticals
Wedderspoon USA
Investigators
Principal Investigator: Elizabeth Leon, MD University of Florida, Department of Otolaryngology
Principal Investigator: Elizabeth Leon, MD Malcom Randall VA Medical Center
  More Information

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02097576     History of Changes
Other Study ID Numbers: 2014Leon
First Submitted: March 24, 2014
First Posted: March 27, 2014
Last Update Posted: July 18, 2014
Last Verified: July 2014

Keywords provided by University of Florida:
Chronic Rhinosinusitis

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases