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Pilot, comparative, randomized, controlled trial assessing the safety and efficacy of manuka honey in the treatment of sinonasal bacterial infections in chronic rhinosinusitis

Not Applicable
Completed
Conditions
Chronic rhinosinusitis
Infection - Studies of infection and infectious agents
Registration Number
ACTRN12616000136404
Lead Sponsor
Adelaide University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
20
Inclusion Criteria

(1)Those who have had symptoms of chronic rhinosinusitis (nasal discharge, postnasal drip, nasal obstruction, facial pain and pressure, lack of sense of smell) that has been previously persistent for greater than 3 months
(2)Have had at least one operation for their chronic rhinosinusitis
(3)Continue to have ongoing symptoms despite surgical management
(4)Have a positive sinonasal swab that indicates a bacterial infection
(5)Over 18 years of age
(6)Are able to give written informed consent
(7)Are local patients who will be returning to this centre for postoperative follow-up care

Exclusion Criteria

(1)A diagnosis of cystic fibrosis
(2)Pregnant or breastfeeding
(3)Immunocompromised patients
(4)Patients actively taking oral steroids
(5)Patients who have used antibiotics within 1 month prior to the trial.
(6)Fructose intolerance/allergy

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Removal of active infection. This will be assess through endoscopic evaluation of the nose as well as by taking a swab from the patients nose to identify if any pathogenic bacteria are present.[Immediately post-treatment ];Assessment of endoscopic score. This will be assessed by endoscopically examining the nasal passage of the patients and recording this examination. The video will then be scored by a blinded observer using the Lund-Kennedy scoring system.[Immediately post-treatment];Assessing the safety of the manuka honey flushes. This will be done by having patients self report any discomfort, pain or health problems that occur during the treatment period. [Immediately post-treatment]
Secondary Outcome Measures
NameTimeMethod
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