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Effectiveness of montelukast plus bilastine vs montelukast plus levocetirizine in allergic rhinitis.

Comparison of efficacy, safety and cost effectiveness of montelukast plus bilastine versus montelukast plus levocetirizine in patients of allergic rhinitis: prospective , randomised, open label parallel study - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/071971
Enrollment
66
Registered
2024-08-06
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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 plus Bilastine: Tab Montelukast 10 mg + Bilastine 20 mg (FDC) once daily for 4 weeks. Control Intervention1: Montelukast plus levocetirizine: Tab Montelukast 10 mg + Levocet

Sponsors

Dr Ganesh Dakhale
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients suffering from non-specific allergic rhinitis of either gender, in age group 18 to 65 years. 2. History of intermittent or persistent allergic rhinitis of any severity with no obvious cause prior to inclusion in study. 3. Patients with TNSS greater than 8 not treated with anti-histamines in last 7 days.

Exclusion criteria

Exclusion criteria: 1. History of asthma requiring chronic use of inhaled corticosteroids. 2. Had been unresponsive to anti-histamine in the past. 3. History of allergy to the study medication or unable to tolerate anti-histamines. 4. Use of study drug in last 1 week prior to baseline. 5. Pregnant and nursing women. 6. Subjects with history of significant haematopoietic, hepatic, renal, cardiovascular, neurological, psychiatric or autoimmune disease.

Design outcomes

Primary

MeasureTime frame
Change in total nasal symptom score (TNSS)Timepoint: at baseline, week 2, week 4

Secondary

MeasureTime frame
Number of adverse events in group A & Group BTimepoint: during 4 weeks of study period;To compare Cost effectiveness ratio between group A & group BTimepoint: at 4 weeks

Countries

India

Contacts

Public ContactDr Ganesh Dakhale

All India Institute of Medical Sciences, Nagpur

drmkumar1994@gmail.com7814523047

Outcome results

None listed

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