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To compare the efficacy of three postoperative treatment modalities combined itraconazole and topical steroids

To compare the efficacy of Combined itraconazole with topical steroid, systemic steroids with the topical steroid and the topical steroid alone in post-operative patients with allergic fungal rhinosinusitis . - NIL

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089528
Enrollment
75
Registered
2025-06-25
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Health Condition 1: J324- Chronic pansinusitis

Interventions

Intervention1: Group A-Oral Itraconazole and Fluticasone Propionate Nasal Spray: Oral Itraconazole 100 mg OD for 3 Months Fluticasone Propionate Nasal Spray 2 puffs (100mcg) twice daily for 6 Mont

Sponsors

Government Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -Patients aged 18 to 60 years. -Post operative AFRS patient Diagnosed with AFRS based on Bent and Kuhn criteria.

Exclusion criteria

Exclusion criteria: -Patients with invasive fungal sinusitis. -Uncontrolled DM -Recurrent cases. -Known allergy or contraindication to itraconazole. -Pre-existing liver disease or abnormal LFTs. -Pregnancy or Lactation. -Patient refused to give consent

Design outcomes

Primary

MeasureTime frame
To assess the rate of disease recurrence in each treatment group from baseline to end of treatmentTimepoint: From Baseline to End of treatment.

Secondary

MeasureTime frame
To evaluate the changes in serum IgE levels and eosinophil countTimepoint: from baseline to end of treatment.

Countries

India

Contacts

Public ContactDr Nikhil Kumar

Government Institute of Medical Sciences

nikhilkumar17064362@gmail.com8182067048

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026