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Silver Nanoparticle Investigation for Treating Chronic Sinusitis

The Efficacy and Safety of Intranasal Colloidal Silver Nanoparticles for Chronic Rhinosinusitis: A Proof-Of-Concept, Double-Blinded, Placebo-Controlled, Randomized Trial

Status
Withdrawn
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03243201
Acronym
SNITCH
Enrollment
0
Registered
2017-08-08
Start date
2018-01-31
Completion date
2018-12-31
Last updated
2018-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Rhinosinusitis (Diagnosis)

Brief summary

Chronic rhinosinusitis is a highly prevalent disease resulting in high economic burden. Effective therapeutic options are needed. Rhinosinusitis-related biofilms are a likely contributor to recalcitrant disease. Emerging evidence shows that colloidal silver nanoparticles may be effective for reducing biofilms. The investigators intend to perform a randomized, double-blinded, placebo-controlled clinical trial to evaluate the effectiveness and safety of intranasal colloidal silver nanoparticles in adult patients with chronic rhinosinusitis. The investigators hypothesize that compared to placebo, treatment with intranasal colloidal silver for chronic rhinosinusitis will lead to a significant improvement in symptom scores and will not be associated with increased rate of adverse effects.

Interventions

DRUGColloidal silver nanoparticles

Contains 10ppm colloidal silver nanoparticles

Purified water will be given as placebo

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Twelve (12) weeks or longer of two or more of the following signs and symptom consistent with chronic rhinosinusitis (CRS): * mucopurulent drainage (anterior, posterior, or both), nasal obstruction (congestion), facial pain-pressure-fullness, or decreased sense of smell AND inflammation is documented by one or more of the following findings: * purulent (not clear) mucus or edema in the middle meatus or ethmoid region * polyps in nasal cavity or the middle meatus * and/or radiographic imaging showing inflammation of the paranasal sinuses

Exclusion criteria

* Unable to speak English * History of nasal or sinus surgery within past 6 weeks * History of comorbid ciliary dyskinesia, cystic fibrosis or any other mucociliary condition * Dependence on prolonged corticosteroid therapy for comorbid condition * History of renal impairment * History of cerebrospinal fluid leak

Design outcomes

Primary

MeasureTime frameDescription
Sino-Nasal Outcome Test (SNOT-22)Four weeksAssess change in SNOT-22 score

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026