Clinical trial NCT02097576: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Rhinosinusitis
Keywords: Chronic Rhinosinusitis
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: NeilMed Pharmaceuticals
First posted: 2014-03-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in SNOT-22 Symptomatic Scores at 1 month
timeFrame: Change from baseline at 1 month
measure: Change in SNOT-22 Symptomatic Scores at 3 months
timeFrame: Change from baseline at 3 months
measure: Change in SNOT-22 Symptomatic Scores at 6 months
timeFrame: Change from baseline at 6 months
Secondary outcomes:
measure: Change in Endoscopic Scores of CRS severity in the different treatment arms at 1 month
timeFrame: Change in baseline at 1 month
measure: Change in Endoscopic Scores of CRS severity in the different treatment arms at 3 months
timeFrame: Change in baseline at 3 months
measure: Change in Endoscopic Scores of CRS severity in the different treatment arms at 6 months
timeFrame: Change in baseline at 6 months
measure: Change in Radiologic Scores of CRS severity in the different treatment arms at 3 months
timeFrame: Change in baseline at 3 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Florida, Department of Otolaryngology
name: Elizabeth Leon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Malcom Randall VA Medical Center
name: Elizabeth Leon, MD
role: PRINCIPAL_INVESTIGATOR
References: