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Manuka Honey Nasal Rinse Study

Primary Purpose

Rhinosinusitis

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Saline mixed with Manuka Honey
NeilMed Saline Sinus Rinse
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinosinusitis focused on measuring Chronic Rhinosinusitis

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    NeilMed Saline Sinus Rinse

    Saline mixed with Manuka Honey

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Change in SNOT-22 Symptomatic Scores 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
    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
    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
    Change in Endoscopic Scores of CRS severity in the different treatment arms at 3 months
    Change in Endoscopic Scores of CRS severity in the different treatment arms at 6 months
    Change in Radiologic Scores of CRS severity in the different treatment arms at 3 months

    Full Information

    First Posted
    March 24, 2014
    Last Updated
    April 23, 2020
    Sponsor
    University of Florida
    Collaborators
    NeilMed Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02097576
    Brief Title
    Manuka Honey Nasal Rinse Study
    Official Title
    Effectiveness of Manuka Honey/Saline Nasal Rinses as an Adjunct to Standard Medical Therapy for Chronic Rhinosinusitis: A Prospective Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Funding withdrawn.
    Study Start Date
    May 2014 (undefined)
    Primary Completion Date
    December 2015 (Anticipated)
    Study Completion Date
    December 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Florida
    Collaborators
    NeilMed Pharmaceuticals

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rhinosinusitis
    Keywords
    Chronic Rhinosinusitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    NeilMed Saline Sinus Rinse
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Saline mixed with Manuka Honey
    Arm Type
    Active Comparator
    Arm Description
    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 Type
    Other
    Intervention Name(s)
    Saline mixed with Manuka Honey
    Other Intervention Name(s)
    NeilMed® Sinus Rinse, Manuka Honey
    Intervention Description
    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 Type
    Other
    Intervention Name(s)
    NeilMed Saline Sinus Rinse
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in SNOT-22 Symptomatic Scores at 1 month
    Description
    There are 22 questions, each scored 0 - 5. Possible scores are 0 - 110. The best score is 0, the worst score is 110.
    Time Frame
    Change from baseline at 1 month
    Title
    Change in SNOT-22 Symptomatic Scores at 3 months
    Description
    There are 22 questions, each scored 0 - 5. Possible scores are 0 - 110. The best score is 0, the worst score is 110.
    Time Frame
    Change from baseline at 3 months
    Title
    Change in SNOT-22 Symptomatic Scores at 6 months
    Description
    There are 22 questions, each scored 0 - 5. Possible scores are 0 - 110. The best score is 0, the worst score is 110.
    Time Frame
    Change from baseline at 6 months
    Secondary Outcome Measure Information:
    Title
    Change in Endoscopic Scores of CRS severity in the different treatment arms at 1 month
    Time Frame
    Change in baseline at 1 month
    Title
    Change in Endoscopic Scores of CRS severity in the different treatment arms at 3 months
    Time Frame
    Change in baseline at 3 months
    Title
    Change in Endoscopic Scores of CRS severity in the different treatment arms at 6 months
    Time Frame
    Change in baseline at 6 months
    Title
    Change in Radiologic Scores of CRS severity in the different treatment arms at 3 months
    Time Frame
    Change in baseline at 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    89 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elizabeth Leon, MD
    Organizational Affiliation
    University of Florida, Department of Otolaryngology
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Elizabeth Leon, MD
    Organizational Affiliation
    Malcom Randall VA Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Manuka Honey Nasal Rinse Study

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