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The Effectiveness of Topical Silver Colloid in Treating Patients With Recalcitrant Chronic Rhinosinusitis (CRS)

This study is currently recruiting participants.
Verified September 2016 by Leigh Sowerby, Lawson Health Research Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT02403479
First Posted: March 31, 2015
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Leigh Sowerby, Lawson Health Research Institute
  Purpose
Chronic rhinosinusitis without polyposis (CRSsP) is a very common condition that occurs when the lining of the sinuses becomes persistently irritated. Standard management options include topical steroids, antibiotics and surgery, but treatment-resistant CRSsP is frequently encountered. Bacterial biofilms are routinely detected within the nasal mucosa of CRSsP patients and are now thought to play an important role in the protracted nature of the disease. Colloidal silver is a widely used naturopathic agent that has recently been shown to eliminate bacteria, and in particular in vitro sinusitis biofilms, in laboratory studies. Although silver is currently used in a variety of chronic wound therapies, it has not yet been formally studied in people with CRSsP. It is our intention with this project to determine whether colloidal silver is a useful treatment strategy for patients with refractory CRS.

Condition Intervention Phase
Rhinosinusitis Drug: Topical silver colloid Other: Topical Saline Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Phase 2 Study Examining the Effects of Topical Intranasal Silver Colloid in Patients With Recalcitrant Chronic Rhinosinusitis

Further study details as provided by Leigh Sowerby, Lawson Health Research Institute:

Primary Outcome Measures:
  • Number of participants with clinical improvement of sinonasal symptoms as a measure of post treatment changes in SNOT-22, Lund Kennedy and SIT test scores [ Time Frame: Three months ]

Secondary Outcome Measures:
  • The reduction of overall cost of treatment of recalcitrant CRS as a comparable measure between the price of silver colloid and standard therapies [ Time Frame: Three months ]

Estimated Enrollment: 20
Study Start Date: September 2015
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
Cross-over control Each participant does 6 weeks of topical nasal saline, followed by 6 weeks of topical nasal silver colloid (Dose= 6.7mcg silver daily; Frequency= 2 sprays in each nostril daily; Route= Topical intra-nasal spray; Duration= 3 months)
Drug: Topical silver colloid
Patients will be provided with a standardized silver colloid spray and asked to place two sprays into each nostril daily for a total of three consecutive months. The commercially available silver colloid product, Sovereign Silver Mineral Supplement, will be used.
Other Name: Silver Hydrosyl by Sovereign Silver
Other: Topical Saline
Active Comparator: Experimental
Each participant receives the full 12 weeks of topical nasal silver colloid (Dose= 6.7mcg silver daily; Frequency= 2 sprays in each nostril daily; Route= Topical intra-nasal spray; Duration= 3 months)
Drug: Topical silver colloid
Patients will be provided with a standardized silver colloid spray and asked to place two sprays into each nostril daily for a total of three consecutive months. The commercially available silver colloid product, Sovereign Silver Mineral Supplement, will be used.
Other Name: Silver Hydrosyl by Sovereign Silver

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A history of twelve or more weeks with at least 2 of the following:

    • Nasal congestion
    • Mucus discharge from the nose or mucus that drips down the back of the throat
    • Facial pain or pressure
    • A decrease sense of smell
  • A history of at least 2 of the following

    • One or more failed functional endoscopic sinus surgeries for CRS
    • Failed oral, culture-directed antibiotic therapy for CRS
    • Failed oral or topical steroid therapy for CRS
    • Failed baby shampoo nasal irrigation therapy for CRS
    • Failed topical mupirocin therapy for CRS
    • Failed Manuka honey irrigations for CRS
    • Failed budesonide irrigations for CRS

Exclusion Criteria:

  • Patients with nasal polyposis
  • Patients with existing autoimmune disorders
  • Patients with an allergy to silver
  • Patients with diabetes
  • Patients that have previously used colloidal silver as a naturopathic remedy
  • Patients that are pregnant, attempting/planning to become pregnant or breastfeeding
  • Patients below the age of 18 years
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02403479


Contacts
Contact: Leigh Sowerby, MD 519-646-6143 leigh.sowerby@sjhc.london.on.ca
Contact: John R Scott, MD 519-902-7737 jscott79@uwo.ca

Locations
Canada, Ontario
Saint Joseph's Health Care Recruiting
London, Ontario, Canada, N6A 4V2
Contact: Leigh Sowerby, MD, MHM, FRCSC       leigh.sowerby@gmail.com   
Contact: John Scott, MD    519-902-7737    jscott79@uwo.ca   
St. Joseph's Health Care Recruiting
London, Ontario, Canada
Contact: Leigh Sowerby         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Leigh Sowerby, MD Schulich School of Medicine and Dentistry/Otolaryngology
  More Information

Responsible Party: Leigh Sowerby, Assistant Professor, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02403479     History of Changes
Other Study ID Numbers: 106309
First Submitted: March 1, 2015
First Posted: March 31, 2015
Last Update Posted: October 12, 2017
Last Verified: September 2016

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases