Health Condition 1: J019- Acute sinusitis, unspecified Health Condition 2: null- ALLERGIC RHINITIS
Conditions
Interventions
Intervention1: Montelukast + Olopatadine tablets: Once daily for 2 weeks
Control Intervention1: Montelukast + Levocetirizine tablets.: Once daily for 2 weeks
Sponsors
Ajanta PharmaLtd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patient with signs and symptoms of allergic rhinitis. 2.Availability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
Exclusion criteria
Exclusion criteria: Males or females, <18 or >60 years of age. Significant history or presence of gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of common medications. Any clinical significant illness during the 4 weeks prior to day 1 of this study. Pregnant, possibly pregnant, or lactating women. Maintenance therapy with any drug, or history of drug dependency, alcohol abuse, or serious neurological or psychological disease. Use of enzyme-modifying drugs within 30 days prior to day 1 of this study. HIV positive subjects. Participation in clinical trial with an investigation drug within 30 days proceeding day one of this study. Any condition that in the opinion of the investigator, does not justify the patient?s inclusion in the study. History of hypersensitivity to the study drug or similar class of drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sneezing, Nasal congestion, Nasal itching, Rhinorrhea, HeadacheTimepoint: Day 1, week 1 and week 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Global assessmentTimepoint: Week 2;Health Related Quality of Life Questionnaire for Allergic RhinitisTimepoint: Day 1 and week 2 | — |
Countries
India
Contacts
Public ContactDr Shailesh Singh
Ajanta Pharma Ltd, Advent
Outcome results
None listed