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Clinical Trials/CTRI/2025/09/094343
CTRI/2025/09/094343
Not yet recruiting
Phase 4

A comparative study to evaluate the safety and efficacy of Tablet Montelukast with Fexofenadine versus Tablet Montelukast with Levocetirizine in patient of Allergic Rhinitis in tertiary care centre.

Dr Preeti Sahani1 site in 1 country277 target enrollmentStarted: September 18, 2025Last updated:

Overview

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Dr Preeti Sahani
Enrollment
277
Locations
1
Primary Endpoint
Reduction in the Total Nasal Symptom Score over 15 days 1st

Overview

Brief Summary

Allergic rhinitis AR is a common chronic IgE mediated inflammatory condition of the nasal mucosa triggered by allergens presenting with symptoms such as sneezing nasal congestion rhinorrhea and nasal itching Combination therapy with leukotriene receptor antagonists and antihistamines is widely used to achieve better symptom control This study aims to compare the safety and efficacy of two such combinations Montelukast with Fexofenadine versus Montelukast with Levocetirizine in patients diagnosed with allergic rhinitis attending a tertiary care centre This prospective randomized open label study will involve 277 patients aged 18 to 65 years divided equally into two groups Group A will receive Montelukast 10 mg with Fexofenadine 120 mg once daily while Group B will receive Montelukast 10 mg with Levocetirizine 5 mg once daily The follow up will be done at 15 days one month and two months Efficacy will be assessed using the Total Nasal Symptom Score TNSS and quality of life questionnaires Safety will be evaluated based on reported adverse effects particularly sedation and any laboratory parameters if required It is anticipated that both combinations will offer significant symptomatic relief Montelukast Fexofenadine may show better tolerability with fewer sedative effects whereas Montelukast Levocetirizine may provide slightly superior symptom control with more sedation The findings may help clinicians choose the most appropriate and patient friendly option for allergic rhinitis Ethical approval and informed consent will be ensured throughout the study

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Male & females aged 18 years and 65 years All diagnosed patients with Allergic Rhinitis attending the outpatient department BRD Medical college Gorakhpur Patients giving written informed consent will be taken.

Exclusion Criteria

  • Patients with a history of hypersensitivity to study drugs Significant comorbid conditions such as Hypertension and Diabetes Mellitus Those on concurrent medications that might interfere with the study Pregnant and Lactating women Not giving consent.

Outcomes

Primary Outcomes

Reduction in the Total Nasal Symptom Score over 15 days 1st

Time Frame: Reduction in the Total Nasal Symptom Score over 15 days 1st | month 2nd month and 3rd month

month 2nd month and 3rd month

Time Frame: Reduction in the Total Nasal Symptom Score over 15 days 1st | month 2nd month and 3rd month

Secondary Outcomes

  • Safety assessment through monitoring adverse events(Patient reported quality of life using the Rhinoconjunctivitis Quality of)

Investigators

Sponsor
Dr Preeti Sahani
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Preeti Sahani

B.R.D.Medical College

Study Sites (1)

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