Silver Nanoparticle Investigation for Treating Chronic Sinusitis

NCT ID: NCT03243201

Last Updated: 2018-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-31

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Rhinosinusitis (Diagnosis)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Colloidal Silver

The colloidal silver arm will administer intranasal colloidal silver, 2 sprays each nostril twice daily, for a total volume of 0.8ml per day (8 mcg of silver per day), for 28 days.

Group Type EXPERIMENTAL

Colloidal silver nanoparticles

Intervention Type DRUG

Contains 10ppm colloidal silver nanoparticles

Purified Water

The placebo arm will administer intranasal purified water, 2 sprays each nostril twice daily, for a total volume of 0.8ml per day, for 28 days.

Group Type PLACEBO_COMPARATOR

Purified Water

Intervention Type OTHER

Purified water will be given as placebo

Interventions

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Colloidal silver nanoparticles

Contains 10ppm colloidal silver nanoparticles

Intervention Type DRUG

Purified Water

Purified water will be given as placebo

Intervention Type OTHER

Other Intervention Names

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Sovereign Silver, Bio-Active Silver Hydrosol

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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159084

Identifier Type: -

Identifier Source: org_study_id

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