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The role of oral steroids with itraconazole versus antibiotics in allergic fungal rhinosinusitis

Comparative study of the role of oral steroids with itraconazole antibiotics in allergic fungal rhinosinusitis - nil

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/074920
Enrollment
100
Registered
2024-10-08
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

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

Conditions

Health Condition 1: J308- Other allergic rhinitis

Interventions

Intervention1: Oral antibiotics and oral steroids: Oral antibiotics (amoxicillin and clavulanic acid 625 mg TDS for adults and children weighing more than 40 kg
if intolerance to Amoxycillin present then 3 rd generation cephalosporins will be administered) with steroids in tapering dose (1 mg/kg OD) in tapering doses for 15 days Control Intervention1: Oral It

Sponsors

Government Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of allergic fungal rhinosinusitis diagnosed on the basis of NCCT scan Nose Paranasal sinuses findings.

Exclusion criteria

Exclusion criteria: 1.History of previous surgery 2. Contraindications of steroid use: a. Diabetes mellitus b. Peptic ulcer disease c. Tuberculosis d. Osteoporosis e. Glaucoma f. Congestive heart failure g. Subcapsular cataract 3. Samter’s triad (bronchial asthma, nasal polyps, aspirin intolerance) 4. Hepatic disease 5. Drugs metabolised extensively by CYP3A4

Design outcomes

Primary

MeasureTime frame
Compare efficacy of oral itraconazole and oral antibiotics versus oral steroids in Allergic Fungal Rhinosinusitis using: 1. NCCT nose PNS (Lund and Mackey radiological scoring system) 2. serum Total IgE levels Timepoint: 15 days per participant

Secondary

MeasureTime frame
Compare efficacy of oral itraconazole and oral antibiotics versus oral steroids in Allergic Fungal Rhinosinusitis using: 1. nasal endoscopy (Kupferberg Endoscopic Scoring and Lund Kennedy scoring system) 2. Sinonasal Outcome Test -22 score and Visual analogue scale scores with respect to nasal endoscopic scoringTimepoint: 15 days per participant

Countries

India

Contacts

Public ContactTanisha Goel

Government Medical College and Hospital, Chandigarh

singhalsks@gmail.com9646121547

Outcome results

None listed

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