Manuka Honey Nasal Rinse Study

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02097576
• Other study ID #: 2014Leon
• Status: Withdrawn
• Phase: N/A
• Start date: May 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2020
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn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

Related Conditions & MeSH terms

• Rhinosinusitis
• Sinusitis

Intervention

Other:
• Saline mixed with Manuka Honey
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.
• NeilMed Saline Sinus Rinse
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	NeilMed Pharmaceuticals

Outcome

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