Health Condition 1: J324- Chronic pansinusitis
Conditions
Interventions
Intervention1: Ringers Lactate Nasal Douching Solution: Ringers Lactate Nasal Douching Solution:
The Ringers lactate nasal douching solution will serve as one of the two treatment arms in this randomi
Sponsors
Indira Gandhi medical College and hospital Shimla
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1. Age And Gender: Adults aged between eighteen to sixty-five years, regardless of gender. 2. Diagnosis Of Chronic Rhinosinusitis (CRS): Diagnosed with Chronic Rhinosinusitis based on the European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS Two Thousand Twenty) criteria, characterized by the following: Symptom Duration: Presence of symptoms for a minimum of twelve weeks. Symptoms: Presence of two or more of the following symptoms, one of which must be either nasal blockage, nasal obstruction, nasal congestion, or nasal discharge (either anterior or posterior nasal drip): Mucopurulent drainage (anterior or posterior) Nasal obstruction or congestion Facial pain, pressure, or fullness Decreased or loss of sense of smell Objective Confirmation: Symptomatology must be confirmed by either: Endoscopic Signs: Presence of nasal polyps, mucopurulent discharge from the middle meatus, or mucosal edema or obstruction in the middle meatus. CT Imaging: Evidence of mucosal alterations in the osteomeatal complex and or sinuses. 3. Inflammatory Documentation: Evidence of sinonasal inflammation must be documented by one or more of the following: Purulent (non-clear) mucus or edema in the middle meatus or ethmoid region Presence of nasal polyps in the nasal cavity or middle meatus Radiographic imaging showing inflammation in the paranasal sinuses 4. Willingness To Participate: Patients must be willing to provide informed consent and agree to adhere to all study protocols.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Pregnancy And Lactation: Pregnant or breastfeeding women. 2. Severe Comorbid Conditions: Presence of severe uncontrolled comorbidities such as: Uncontrolled diabetes Autoimmune diseases Severe cardiovascular or respiratory diseases 3. Known Allergies: Allergies to components of the nasal irrigation solutions, including Ringers lactate or buffered hypertonic saline. 4. Language Barrier: Patients unable to speak or understand Hindi or English. 5. Mucociliary Disorders: History of primary ciliary dyskinesia, cystic fibrosis, or other significant mucociliary dysfunction. 6. Dependence On Corticosteroids: Patients requiring prolonged systemic corticosteroid therapy for comorbid conditions like asthma or chronic obstructive pulmonary disease. 7. Infections And Other Nasal Conditions: History of cerebrospinal fluid leak Current infection or history of: Tuberculosis lung infection Herpes infection of the eye 8. Surgical History And Disorders: Previous nasal or sinus surgery within the last three months unrelated to the current chronic rhinosinusitis condition. 9. SNOT Twenty Two Score: Patients with baseline SNOT Twenty Two scores below nine, as they may not achieve a minimally clinically significant improvement in the study. 10. Bleeding Disorders Or Allergy To Anesthetics: Known bleeding disorders, use of blood thinners, or allergies to topical or injectable lidocaine. 11. Other Exclusions: Patients unwilling or unable to comply with study protocols or follow-up visits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome: Change in Sino Nasal Outcome Test Twenty Two (SNOT Twenty Two) Scores: The primary outcome is the change in SNOT Twenty Two scores from baseline to the end of the treatment period, which is six weeks. SNOT Twenty Two is a validated patient reported outcome measure assessing the severity of sinonasal symptoms and their impact on quality of life. Scores range from zero to one hundred ten, with higher scores indicating worse symptoms. Changes in SNOT Twenty Two will be compared between the Buffered Hypertonic Saline and Ringer?s Lactate groups. Timepoint: Baseline to the end of the treatment period, which is six weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Lund Kennedy?s Score via Nasal Endoscopy Findings Patient comfort levels will be assessed using a Likert scale (1-10) Adherence to the nasal irrigation regimen will be monitored through self-reported usage logs collected during each follow-up visitTimepoint: Baseline to the end of the treatment period, which is six weeks | — |
Countries
India
Contacts
Public ContactProfessor Dr Ramesh Azad
Indira Gandhi medical College and hospital
Outcome results
None listed