| CTRI Number |
CTRI/2025/09/094057 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study on the Effectiveness, Safety, and Cost-Effectiveness of Two Allergy Medications in South Indian Patients with Allergic Rhinitis |
|
Scientific Title of Study
|
A prospective comparative study to evaluate the efficacy, safety and cost-effectiveness of montelukast-fexofenadine and montelukast-bilastine in patients with allergic rhinitis in south indian population |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gokula Kannan S |
| Designation |
PG student |
| Affiliation |
ACS Medical College and Hospital |
| Address |
Department of Pharmacology, ACS Medical College, Velappanchavadi , Thiruvallur,
Tamilnadu,
India
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
6383916422 |
| Fax |
|
| Email |
vssclinic1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B Kalaiselvi |
| Designation |
Professor and Unit chief |
| Affiliation |
ACS Medical College and Hospital |
| Address |
Department of Pharmacology, ACS Medical College, Velappanchavadi , Thiruvallur,
Tamilnadu,
India
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9840311021 |
| Fax |
|
| Email |
drbkalaiselvi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gokula Kannan S |
| Designation |
PG student |
| Affiliation |
ACS Medical College and Hospital |
| Address |
Department of Pharmacology, ACS Medical College, Velappanchavadi , Thiruvallur,
Tamilnadu,
India
TAMIL NADU
600077
India |
| Phone |
6383916422 |
| Fax |
|
| Email |
vssclinic1@gmail.com |
|
|
Source of Monetary or Material Support
|
| ACS medical college and hospital, Velappanchavadi, Tiruvallur, Tamilnadu, India - 600077 |
|
|
Primary Sponsor
|
| Name |
Dr Gokula Kannan S |
| Address |
Department of Pharmacology, ACS Medical College, Velappanchavadi , Thiruvallur,
Tamilnadu,
India - 600077 |
| 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 Gokula Kannan S |
ACS medical college and hospital |
Room no. 11, 1st floor, Department of Pharmacology, College block
Thiruvallur
TAMIL NADU |
6383916422
vssclinic1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGR INSTITUTE (ACS MEDICAL COLLEGE AND HOSPITAL |
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 |
| Comparator Agent |
Montelukast-Bilastine |
Persons diagnosed with Allergic Rhinitis will be divided randomly into two groups, A (Montelukast-Fexofenadine) and B (Montelukast-Bilastine) will be given daily at night in empty stomach and they will be followed up after 4 weeks with the TNSS score questionnaire.
|
| Intervention |
Montelukast-Fexofenadine |
Persons diagnosed with Allergic Rhinitis will be divided randomly into two groups, A (Montelukast-Fexofenadine) and B (Montelukast-Bilastine) will be given daily at night in empty stomach and they will be followed up after 4 weeks with the TNSS score questionnaire.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age group of 18 to 65 years
Both gender having moderate to severe intermittent or mild persistent Allergic rhinitis
Patients with positive history of Bronchial Asthma
Not treated with antihistaminics in the previous week
Patients willing to sign written informed consent
Complying with the study procedure
Free of any clinically significant disease and having normal electrocardiography
|
|
| ExclusionCriteria |
| Details |
Age less than 18 years
Pregnant female
Nursing mothers
History of allergies to study medication or tolerance to antihistamines and use of study drug in the past 7 days
Patients with significant hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric or autoimmune diseases are excluded from the study |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Montelukast-Fexofenadine and Montelukast-Bilastine combination in patients with Allergic Rhinitis using TNSS scoring system. |
After 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the safety of Montelukast-Fexofenadine and Montelukast-Bilastine combination in patients with Allergic Rhinitis by vigilant follow-up of patients for the treatment of emergent adverse events
|
After 1 month |
To evaluate the cost-effectiveness of Montelukast-Fexofenadine and Montelukast-Bilastine combination in patients with Allergic Rhinitis
|
After 1 month |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
01/10/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Persons diagnosed with Allergic Rhinitis will be divided randomly into two groups, A (Montelukast and Fexofenadine) and B (Montelukast and Bilastine) will be given daily at night in empty stomach and they will be followed up after 4 weeks with the TNSS score questionnaire. Blood parameters such as CBC, LFT, RFT at baseline and after 4 weeks will be assessed. Primary outcome will be the composite TNSS score at baseline and at 4th week. Secondary outcome will be any adverse effects and cost effectiveness of the drugs. Cost-effectiveness ratio is equal to cost divided by outcome Outcome will be measured in terms of effectiveness. TNSS parameter is the main effectiveness parameter. |