Rhinosinusitis Clinical Trial
Official title:
Effectiveness of Manuka Honey/Saline Nasal Rinses as an Adjunct to Standard Medical Therapy for Chronic Rhinosinusitis: A Prospective Clinical Trial
NCT number | NCT02097576 |
Other study ID # | 2014Leon |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2014 |
Est. completion date | December 2015 |
Verified date | April 2020 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Florida | NeilMed Pharmaceuticals |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 from baseline at 1 month | |
Primary | 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 from baseline at 3 months | |
Primary | 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. | Change from baseline at 6 months | |
Secondary | Change in Endoscopic Scores of CRS severity in the different treatment arms at 1 month | Change in baseline at 1 month | ||
Secondary | Change in Endoscopic Scores of CRS severity in the different treatment arms at 3 months | Change in baseline at 3 months | ||
Secondary | Change in Endoscopic Scores of CRS severity in the different treatment arms at 6 months | Change in baseline at 6 months | ||
Secondary | Change in Radiologic Scores of CRS severity in the different treatment arms at 3 months | Change in baseline at 3 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT02636790 -
Early Versus Late Surgical Wait Times
|
Early Phase 1 | |
Completed |
NCT02712502 -
Levofloxacin in Bacterial Rhinosinussitis
|
N/A | |
Completed |
NCT00986830 -
Healthcare Utilization and Outcomes of FinESS Treatment in the Office
|
N/A | |
Completed |
NCT00534079 -
Nasal Inhalation of Pulmozyme in Patients With Cystic Fibrosis and Chronic Rhinosinusitis
|
Phase 3 | |
Completed |
NCT05442606 -
Physiotherapy Protocol in Treating Chronic Rhinosinusitis
|
N/A | |
Completed |
NCT01955980 -
Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis
|
Phase 1/Phase 2 | |
Completed |
NCT04123405 -
Efficacy and Safety of Acetylcysteine for the Treatment of Acute Uncomplicated Rhinosinusitis
|
Phase 3 | |
Completed |
NCT00797004 -
Olfactory Dysfunction of Rhinosinusitis
|
N/A | |
Recruiting |
NCT05494346 -
Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction
|
N/A | |
Not yet recruiting |
NCT05836935 -
Role of Imaging in Complications of Sinusitis
|
N/A | |
Completed |
NCT01132781 -
Theophylline in Rhinitis
|
Phase 2 | |
Recruiting |
NCT00948519 -
Laser Assisted Treatment of Chronic Sinusitis With and Without Light Activated Agents
|
N/A | |
Completed |
NCT00554190 -
Study to Evaluate Safety and Effectiveness of AdvaCoat Sinus Gel
|
Phase 4 | |
Recruiting |
NCT03729258 -
Efficacy and Safety of Modified Release Cefpodoxime Formulation in the Treatment of Acute Sinusitis.
|
Phase 3 | |
Withdrawn |
NCT03729310 -
Comparison of Two Steroid Nasal Implants Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis
|
Early Phase 1 | |
Recruiting |
NCT01296919 -
The Clinical Significance of the Uncinate Process Histopathology in Chronic Rhinosinusitis
|
N/A | |
Completed |
NCT01086839 -
Sino-nasal Inhalation of Sodium Chloride 6,0% in Patients With Cystic Fibrosis and Chronic Rhinosinusitis
|
N/A | |
Completed |
NCT00849953 -
FinESS Registry Study
|
N/A | |
Withdrawn |
NCT00669799 -
Topical Antibiotic Use In Chronic Rhinosinusitis A Double-Blinded, Randomized, Placebo Controlled Study
|
N/A | |
Completed |
NCT03229551 -
Xylitol for Chronic Sinusitis
|
Phase 2/Phase 3 |