A clinical trial to study the efficacy, safety and tolerability of Montelukast + Olopatadine Tablets vs. Montelukast + Levocetrizine Tablets in patients with Allergic Rhinitis.
- Conditions
- Health Condition 1: J019- Acute sinusitis, unspecifiedHealth Condition 2: null- ALLERGIC RHINITIS
- Registration Number
- CTRI/2010/091/002974
- Lead Sponsor
- Ajanta PharmaLtd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sneezing, Nasal congestion, Nasal itching, Rhinorrhea, HeadacheTimepoint: Day 1, week 1 and week 2
- Secondary Outcome Measures
Name Time Method Global assessmentTimepoint: Week 2;Health Related Quality of Life Questionnaire for Allergic RhinitisTimepoint: Day 1 and week 2