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Itraconazole and clinical and radiologic findings in patients with recurrent chronic rhinosinusitis and nasal polyposis

Phase 2
Conditions
Condition 1: nasal polyposis. Condition 2: Chronic rhinitis.
Nasal polyp
Chronic rhinitis
Registration Number
IRCT201211062106N4
Lead Sponsor
Isfahan University of Medical Sciences, Vice Challenry
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
22
Inclusion Criteria

The inclusion criteria contained patients at least 15 years old without history of hepatic disease and heart failure; without allergy to Itraconazole, and usage of interacting medications (cisapride, dofetilide, ergot derivatives, levomethadyl lovastatin, midazolam (oral), nisoldipine, pimozide, quinidine, simvastatin, or triazolam). Exclusion criteria of the study were no compliance for follow up; side effects of Itraconazole like rising in hepatic enzyme; nausea, vomiting or starting a new treatment during the study.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Severity of rhinorrhea, nasal obstruction, hyposmia, dyspnea. Timepoint: 0, 1st, 3rd and 6th months. Method of measurement: Asking the patient about the score of none, mild, moderate and severe.
Secondary Outcome Measures
NameTimeMethod
Quality of life. Timepoint: 0,1st, 3rd and 6th months. Method of measurement: SNOT-20.;Serum IgE. Timepoint: 0 and 3rd months. Method of measurement: Unit.;Score of CT scan. Timepoint: 0 and 3rd months. Method of measurement: Lund-Mackay scale.;Side effects like elevated liver enzyme, diarrhea and nausea. Timepoint: 0,1st, 3rd and 6th months. Method of measurement: Ask a patient.
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