Manuka Honey Nasal Rinse Study

NCT02097576 | Withdrawn

• 1 other identifier: 2014Leon
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rhinosinusitis

Keywords

Chronic Rhinosinusitis

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (4)

• 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

• 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

Study Arms (2)

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.

Other: NeilMed Saline Sinus Rinse

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.

Other: Saline mixed with Manuka Honey

Interventions

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.

Also known as: NeilMed® Sinus Rinse, Manuka Honey

Saline mixed with Manuka Honey

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.

NeilMed Saline Sinus Rinse

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic Rhinosinusitis
• Nasal Polyposis stages 1-3

You may not qualify if:

• Nasal Polyposis stage 4-5
• Cystic Fibrosis
• Immunocompromised patients
• Allergy to bees or honey

Sponsors & Collaborators

• University of Florida: lead
• NeilMed Pharmaceuticals: collaborator

MeSH Terms

Conditions

Rhinosinusitis

Condition Hierarchy (Ancestors)

Rhinitis; Respiratory Tract Infections; Infections; Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Elizabeth Leon, MD

  University of Florida, Department of Otolaryngology

  PRINCIPAL INVESTIGATOR

• Elizabeth Leon, MD

  Malcom Randall VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: March 27, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 27, 2020

Record last verified: 2020-04