Manuka Honey Nasal Rinse Study
- Conditions
- Rhinosinusitis
- Registration Number
- NCT02097576
- Lead Sponsor
- University of Florida
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Chronic Rhinosinusitis
- Nasal Polyposis stages 1-3
- Nasal Polyposis stage 4-5
- Cystic Fibrosis
- Immunocompromised patients
- Allergy to bees or honey
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in SNOT-22 Symptomatic Scores at 6 months 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.
Change in SNOT-22 Symptomatic Scores at 3 months 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 1 month 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.
- Secondary Outcome Measures
Name Time Method Change in Endoscopic Scores of CRS severity in the different treatment arms at 3 months Change in baseline at 3 months Change in Endoscopic Scores of CRS severity in the different treatment arms at 1 month Change in baseline at 1 month Change in Endoscopic Scores of CRS severity in the different treatment arms at 6 months Change in baseline at 6 months Change in Radiologic Scores of CRS severity in the different treatment arms at 3 months Change in baseline at 3 months