A Study on the Effectiveness, Safety, and Cost-Effectiveness of Two Allergy Medications in South Indian Patients with Allergic Rhinitis

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 - Nil

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/094057

Enrollment

110

Registered

2025-09-01

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J309- Allergic rhinitis, unspecified

Interventions

Intervention1: Montelukast-Fexofenadine: Persons diagnosed with Allergic Rhinitis will be divided randomly into two groups, A (Montelukast-Fexofenadine) and B (Montelukast-Bilastine) will be given dai

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of Montelukast-Fexofenadine and Montelukast-Bilastine combination in patients with Allergic Rhinitis using TNSS scoring system.Timepoint: After 1 month	—

Secondary

Measure	Time frame
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 Timepoint: After 1 month;To evaluate the cost-effectiveness of Montelukast-Fexofenadine and Montelukast-Bilastine combination in patients with Allergic Rhinitis Timepoint: After 1 month	—

Countries

India

Contacts

Public ContactGokula Kannan S

ACS Medical College and Hospital

drbkalaiselvi@gmail.com9840311021

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026