Health Condition 1: J329- Chronic sinusitis, unspecified
Conditions
Interventions
Intervention1: Budesonide enhanced Ringers lactate: Budesonide enhanced Ringer s lactate solution: Each budesonide respule contains 0.5mg/2mL. 1 mg budesonide (2 respules) in 500ml Ringer s lactate pe
Sponsors
Dr Charumathi P C
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects aged from 18 to 65 years, irrespective of gender and willing to give written informed consent are eligible. 2.Subjects with unilateral or bilateral chronic rhinosinusitis with or without nasal polyp (diagnosed according to the criteria outlined in the EPOS 2020 guidelines) who have been documented with failed medical treatment and are planned for FESS for the treatment of CRS.
Exclusion criteria
Exclusion criteria: 1. Subjects with history of known allergies or hypersensitivity to budesonide or any component of Ringer s lactate irrigation solution. 2. Subjects diagnosed with cystic fibrosis, immotile cilia syndrome and sinonasal tumours or obstructive lesions. 3. Subjects using other intranasal medications or therapies (such as antihistamines or decongestants) during the study period will be excluded. 4. Subjects with other ENT conditions that could confound results, such as active middle ear disease, fungal sinusitis, cholesteatoma, or ossicular discontinuity. 5. Subjects who have undergone recent nasal surgeries or who have experienced nasal trauma in the past three months that could affect study results. 6. Subjects with hyperkalaemia, renal or hepatic impairment. 7. Subjects who are pregnant or lactating mothers. 8. Subjects who are immunocompromised (e.g., HIV/AIDS, those on chemotherapy or immunosuppressants).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SNOT-22 Score: Reduction in symptom severity measured by the SNOT 22 questionnaire at baseline (pre-operatively), 3rd week, and 6th week post intervention. 2. LKE Score: Improvement in nasal endoscopy scores (assessing oedema, discharge, polyps, and scarring) at baseline (pre-operatively), 3rd week and 6th week post-intervention. Timepoint: baseline (pre-operatively), 3rd week and 6th week post-intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| HRQL - measured via RSDI questionnaire at baseline, 6th week. 2. Tolerability parameter: Adverse events (e.g., nasal irritation, nasal dryness, burning or stinging sensation, epistaxis, secondary infections, allergic or hypersensitivity reactions) in both the study groups during the study period will be documented & assessed for tolerability.Timepoint: baseline, 6th week. | — |
Countries
India
Contacts
Public ContactDr Charumathi P C
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES
Outcome results
None listed