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临床试验/CTRI/2025/09/094343
CTRI/2025/09/094343尚未招募4 期

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 个研究点 分布在 1 个国家目标入组 277 人开始时间: 2025年9月18日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
277
试验地点
1
主要终点
Reduction in the Total Nasal Symptom Score over 15 days 1st

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

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

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

month 2nd month and 3rd month

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

次要结局

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

研究者

发起方
Dr Preeti Sahani
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Preeti Sahani

B.R.D.Medical College

研究点 (1)

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