| CTRI Number |
CTRI/2025/09/095235 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
14/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISON OF drug ORAL BILASTINE WITH ORAL CETIRIZINE IN ALLERGIC RHINITIS |
|
Scientific Title of Study
|
COMPARISON OF EFFICACY AND SAFETY OF ORAL BILASTINE WITH ORAL CETIRIZINE IN ALLERGIC RHINITIS-AN OPEN LABEL RANDOMISED CONTROLLED TRIAL |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Anwesha1327 |
NIL |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anwesha Das |
| Designation |
Post Graduate Resident Doctor |
| Affiliation |
Agartala Government Medical College and GBP Hospital |
| Address |
Agartala Government Medical College and GBP Hospital Kunjaban Agartala Tripura West
Gajaria S D Mission Agartala Tripura West
West Tripura
TRIPURA
799006
India |
| Phone |
8258802853 |
| Fax |
|
| Email |
anweshadas1399@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Debasis Ray |
| Designation |
Professor and HOD |
| Affiliation |
Agartala Government Medical College and GBP Hospital |
| Address |
Agartala Government Medical College and GBP Hospital Kunjaban Agartala Tripura West
Badharghat Agartala Tripura West
West Tripura
TRIPURA
799006
India |
| Phone |
9436125100 |
| Fax |
|
| Email |
contactdebasisray@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Debasis Ray |
| Designation |
Professor and HOD |
| Affiliation |
Agartala Government Medical College and GBP Hospital |
| Address |
Agartala Government Medical College and GBP Hospital Kunjaban Agartala Tripura West
Badharghat Agartala Tripura West
West Tripura
TRIPURA
799006
India |
| Phone |
9436125100 |
| Fax |
|
| Email |
contactdebasisray@gmail.com |
|
|
Source of Monetary or Material Support
|
| Agartala Government Medical Colllege and GBP Hospital kunjaban Agartala Tripura west PIN 799006 India |
|
|
Primary Sponsor
|
| Name |
Anwesha Das |
| Address |
Agratala Government Medical College and GBP Hospital |
| 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 |
| Anwesha Das |
Agartala Government Medical College & GBP Hospital |
Department of Pharamacology and otorhinolaryngology
West Tripura
TRIPURA |
8258802853
anweshadas1399@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Clinical studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00||Acute nasopharyngitis [common cold], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tab Cetirizine 10mg |
Tab Cetirizine 10mg once daily at bed time for 14 days |
| Intervention |
Tab. Bilastine 20mg |
Tab. Bilastine 20mg once daily at bed time for 14 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All the newly diagnosed Seasonal Allergic Rhinitis patients attending ENT OPD of a Tertiary Care Hospital in the age group of 18 years & above shall be included the study |
|
| ExclusionCriteria |
| Details |
i Patient is suffering from perennial allergic rhinitis & and also from other from rhinitis like vasomotor rhinitis & URTI
ii Patient having any other associated nasal condition like nasal polyp, tumour of nose, rhinosinusitis, any neoplastic condition of nose & PNS
iii Those who have received any form of treatment for allergic rhinitis for last one month or receives steroids
i All diagnosed patients of allergic fungal rhinosinusitis shall be excluded from the study
v Pregnant women and lactating mother shall be excluded from the study
vi Immunocompromised patients shall be excluded from the study
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
a. Total Nasal Symptom Score
b. Total Non-Nasal Symptom Score
c. Mean Total Symptom Score
|
at day 0 day 7 and day 14
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
N/A |
|
Date of First Enrollment (India)
|
13/10/2025 |
| 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="6"
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
|
Thesis Protocol titled COMPARISON OF EFFICACY AND SAFETY OF ORAL BILASTINE WITH ORAL CETIRIZINE IN ALLERGIC RHINITIS AN OPEN LABEL RANDOMISED CONTROLLED TRIAL will be done in North East India in department of pharmacology and otorhinolaryngology to compare the efficacy and safety of the most commonly used drugs for treamtents of Allergic Rhinitis that is oral bilastine and cetirizine Among 2nd generation antihistaminic as an antiallergic only cetirizine has been included in NLEM 2022 But it has been reported that it has some adverse effect like headache sedation and dizziness so if a drug with better efficacy and safety profile can be identified through comparative studies it will be of great help for the patients suffering from Allergic Rhinitis hence this study has been taken up for comparison of the two molecules study period is of 78weeks, 70 weeks for data collection and sample size Case-Record Form containing History general physical examination systemic & local examination along with total nasal & non nasal symptoms score will be used the study tool Consent from particapnts will be taken Data will be entered & analysed in the SPSS version statistical software |