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Gulf War Illness Nasal Irrigation Study

NCT01700725 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-05-21

Study results available
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Summary

The purpose of this study is to determine whether nasal irrigation with Xylitol or saline are effective in the treatment of chronic rhinosinusitis and fatigue symptoms associated with Gulf War Illness.

Conditions

  • Persian Gulf Syndrome
  • Chronic Sinusitis
  • Fatigue
  • Acute Sinusitis

Interventions

OTHER

Nasal Irrigation - Saline

Liquid-based nasal irrigation (NI) is performed using a nasal irrigation cup ("neti pot"), a simple hand-held vessel that uses the force of gravity to gently irrigate the user's nasal cavity. Subjects will be requested to perform NI twice daily. The subjects will prepare the saline solution by themselves using the study-provided kit which will include packets of salt powder and the neti pot; subjects will dissolve the powder in lukewarm tap water to achieve a 2% buffered saline solution. The solution is then delivered to the nasal cavity using neti pot.

DRUG

Nasal Irrigation - Xylitol

Liquid-based nasal irrigation (NI) is performed using a nasal irrigation cup ("neti pot"), a simple hand-held vessel that uses the force of gravity to gently irrigate the user's nasal cavity. Subjects will be requested to perform NI twice daily. The subjects will prepare the Xylitol solution by themselves using the study-provided kit which will include packets of Xylitol powder and the neti pot; subjects will dissolve the powder in lukewarm tap water to achieve a 5% Xylitol solution. The solution is then delivered to the nasal cavity using neti pot.

Sponsors & Collaborators

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Rachel Molander, MD · US Department of Veterans Affairs, William S. Middleton Memorial Veterans Hospital

  • David P Rabago, MD · University of Wisconsin, Madison

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2016-06-30
Completion
2017-05-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01700725 on ClinicalTrials.gov