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Manuka Honey Nasal Rinse Study

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.
 
ClinicalTrials.gov Identifier: NCT02097576
Recruitment Status : Withdrawn (Funding withdrawn.)
First Posted : March 27, 2014
Last Update Posted : April 27, 2020
Sponsor:
Collaborator:
NeilMed Pharmaceuticals
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE March 24, 2014
First Posted Date  ICMJE March 27, 2014
Last Update Posted Date April 27, 2020
Study Start Date  ICMJE May 2014
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2014)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Manuka Honey Nasal Rinse Study
Official Title  ICMJE Effectiveness of Manuka Honey/Saline Nasal Rinses as an Adjunct to Standard Medical Therapy for Chronic Rhinosinusitis: A Prospective Clinical Trial
Brief Summary

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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rhinosinusitis
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: NeilMed Saline Sinus Rinse
  • 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.
    Intervention: Other: Saline mixed with Manuka Honey
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: July 17, 2014)
0
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2014)
150
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT02097576
Other Study ID Numbers  ICMJE 2014Leon
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE NeilMed Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Elizabeth Leon, MD University of Florida, Department of Otolaryngology
Principal Investigator: Elizabeth Leon, MD Malcom Randall VA Medical Center
PRS Account University of Florida
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP