| CTRI Number |
CTRI/2025/09/094343 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Montelukast with Fexofenadine versus Montelukast with Levocetirizine in patients of Allergic Rhinitis in BRD Medical college,Gorakhpur. |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Preeti Sahani |
| Designation |
Junior Resident |
| Affiliation |
B.R.D.Medical College |
| Address |
3rd Floor Department of Pharmacology
B R D medical college
Gorakhpur
UTTAR PRADESH
India
B R D medical college
Gorakhpur
UTTAR PRADESH
India
Gorakhpur
UTTAR PRADESH
273013
India |
| Phone |
8546060202 |
| Fax |
|
| Email |
preetisahani.92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Kumar |
| Designation |
Associate Professor |
| Affiliation |
B.R.D.Medical College |
| Address |
3rd Floor Department of Pharmacology
B R D medical college
Gorakhpur
UTTAR PRADESH
India
B R D medical college
Gorakhpur
UTTAR PRADESH
India
Gorakhpur
UTTAR PRADESH
273013
India |
| Phone |
8303060884 |
| Fax |
|
| Email |
dranilk194@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preeti Sahani |
| Designation |
Junior Resident |
| Affiliation |
B.R.D.Medical College |
| Address |
3rd Floor Department of Pharmacology
B R D medical college
Gorakhpur
UTTAR PRADESH
India
B R D medical college
Gorakhpur
UTTAR PRADESH
India
Gorakhpur
UTTAR PRADESH
273013
India |
| Phone |
8546060202 |
| Fax |
|
| Email |
preetisahani.92@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pharmacology
Baba Raghav Das Medical College
Gorakhpur
273013
Uttar Pradesh
India |
|
|
Primary Sponsor
|
| Name |
Dr Preeti Sahani |
| Address |
100 seated PG girls hostel
B R D Medical College
Gorakhpur
273013
Uttar Pradesh
India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Preeti Sahani |
Baba Raghav Das Medical College |
3rd floor
Department Of
Pharmacology
BRD medical college
Gorakhpur
UTTAR PRADESH
Gorakhpur
UTTAR PRADESH |
08546060202
preetisahani.92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| College Research Council, B R D Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: J309||Allergic rhinitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Montelukast with Fexofanadiene |
10mg+120mg once a day then followup after 15 days,1month,2month,3month. |
| Comparator Agent |
Montelukast with Levocetirizine |
10mg+5mg once a day then followup after 15 days,1month,2month,3month. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in the Total Nasal Symptom Score over 15 days 1st
month 2nd month and 3rd month |
Reduction in the Total Nasal Symptom Score over 15 days 1st
month 2nd month and 3rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Safety assessment through monitoring adverse events
Patient reported quality of life using the Rhinoconjunctivitis Quality of
Life Questionnaire
Patient satisfaction assessed through a Visual Analog Scale |
15 days,1month,2month,3months. |
|
|
Target Sample Size
|
Total Sample Size="277"
Sample Size from India="277"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
18/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 |