RhinosinusitisNCT02097576
Manuka Honey Nasal Rinse Study
A study testing Saline mixed with Manuka Honey and NeilMed Saline Sinus Rinse in people with Rhinosinusitis, run by University of Florida.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Rhinosinusitis
- What is being tested?
- Saline mixed with Manuka Honey and NeilMed Saline Sinus Rinse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic Rhinosinusitis
- Nasal Polyposis stages 1-3
Who cannot join
- Nasal Polyposis stage 4-5
- Cystic Fibrosis
- Immunocompromised patients
- Allergy to bees or honey
About this study
Official title: Effectiveness of Manuka Honey/Saline Nasal Rinses as an Adjunct to Standard Medical Therapy for Chronic Rhinosinusitis: A Prospective Clinical Trial
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.
Read the 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.
- Conditions
- Rhinosinusitis
- Being tested
- Saline mixed with Manuka Honey, NeilMed Saline Sinus Rinse
- Keywords
- Chronic Rhinosinusitis
- Medical subject headings
- Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline mixed with Manuka HoneyOther
Also called NeilMed® Sinus Rinse, 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 RinseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Saline mixed with Manuka Honey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Change from baseline at 6 months
Secondary outcomes (4)
Change in Endoscopic Scores of CRS severity in the different treatment arms at 1 month
Measured: Change in baseline at 1 month
Change in Endoscopic Scores of CRS severity in the different treatment arms at 3 months
Measured: Change in baseline at 3 months
Change in Endoscopic Scores of CRS severity in the different treatment arms at 6 months
Measured: Change in baseline at 6 months
Change in Radiologic Scores of CRS severity in the different treatment arms at 3 months
Measured: Change in baseline at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: Funding withdrawn.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinosinusitisStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- NeilMed Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Elizabeth Leon, MD, Principal investigator, University of Florida, Department of OtolaryngologyElizabeth Leon, MD, Principal investigator, Malcom Randall VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097576
- Sponsor's protocol ID
- 2014Leon
- Status last verified
- Apr 2020
- First submitted
- 24 Mar 2014
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Manuka Honey/Saline Nasal Rinses as an Adjunct to Standard Medical Therapy for Chronic Rhinosinusitis: A Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT02097576
- Acronym / sponsor ID
- 2014Leon
- Conditions
- Rhinosinusitis
- Keywords
- Chronic Rhinosinusitis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding withdrawn.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- NeilMed Pharmaceuticals
- Study start
- May 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 27 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NeilMed Saline Sinus Rinse | Active comparator | Other: NeilMed Saline Sinus RinseSaline 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. |
| Saline mixed with Manuka Honey | Active comparator | Other: Saline mixed with Manuka HoneySaline 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic Rhinosinusitis
- Nasal Polyposis stages 1-3
Key exclusion criteria (4 listed)
- Nasal Polyposis stage 4-5
- Cystic Fibrosis
- Immunocompromised patients
- Allergy to bees or honey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saline mixed with Manuka HoneyAlso: NeilMed® Sinus Rinse, Manuka HoneySaline 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 |
| NeilMed Saline Sinus RinseSaline 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 |
Primary outcome
Change in SNOT-22 Symptomatic Scores at 1 month
Time frame: Change from baseline 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 in SNOT-22 Symptomatic Scores at 3 months
Time frame: Change from baseline 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 in SNOT-22 Symptomatic Scores at 6 months
Time frame: Change from baseline 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.
4 secondary outcomes
Change in Endoscopic Scores of CRS severity in the different treatment arms at 1 month
Time frame: Change in baseline at 1 month
Change in Endoscopic Scores of CRS severity in the different treatment arms at 3 months
Time frame: Change in baseline at 3 months
Change in Endoscopic Scores of CRS severity in the different treatment arms at 6 months
Time frame: Change in baseline at 6 months
Change in Radiologic Scores of CRS severity in the different treatment arms at 3 months
Time frame: Change in baseline at 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
Related trials for Rhinosinusitis
Active, not recruitingPhase 2
Long-term Safety and Efficacy Evaluation of Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Clinical Study
Chronic Rhinosinusitis With Nasal Polyps
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 3
Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Not yet recruiting
FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Chronic Sinusitis, Nasal Polyposis
RecruitingObservational study
Prospective, Non-interventional Single-arm Study With Tezepelumab to Investigate the Change in Clinical and Patient-reported Outcomes in Patients With CRSwNP in Real-world (PETRICHOR)
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Leon, MD principal investigator
University of Florida, Department of Otolaryngology
Elizabeth Leon, MD principal investigator
Malcom Randall VA Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Saline mixed with Manuka Honey and NeilMed Saline Sinus Rinse in people with Rhinosinusitis, run by University of Florida.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SNOT-22 Symptomatic Scores at 1 month (time frame: Change from baseline at 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2020.