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Funding withdrawn.
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| Name | Class |
|---|---|
| NeilMed Pharmaceuticals | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NeilMed Saline Sinus Rinse | Active Comparator | 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. |
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| Saline mixed with Manuka Honey | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline mixed with Manuka Honey | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 3 months | Change in baseline at 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Leon, MD | University of Florida, Department of Otolaryngology | Principal Investigator |
| Elizabeth Leon, MD | Malcom Randall VA Medical Center | Principal Investigator |
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| ID | Term |
|---|---|
| D000096825 | Rhinosinusitis |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D012852 | Sinusitis |
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| NeilMed Saline Sinus Rinse | Other | 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. |
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| 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 |
| D010254 |
| Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |