Health Condition 1: J309- Allergic rhinitis, unspecified
Conditions
Interventions
Intervention1: Tablet.Bilastine 20mg: This oral tablet in this study group will be advised to be taken once daily.The total period of study will be 2 weeks.Follow up will be conducted telephonically a
Sponsors
Government medical college and hospital nagpur
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients between 18 and 65 years of either Gender 2. Patients with diagnosis of intermittent or persistent (mild,moderate,severe) Allergic rhinitis by an ENT Surgeon 3. Patients with TNSS of more than or equal to 8 not treated wiht antihistamines in the last 3 days 4. Patients who can understand and are able to adhere to the dosing and visit schedules 5. Patients who will agree to record the adverse events in the subject diary provided to them accurately and consistently
Exclusion criteria
Exclusion criteria: 1. Patients with H/O asthma requiring chronic use of inhaled or systemic corticosteroids . 2. Patients who have been unresponsive to antihistamine treatment in the past. 3. Patients with a history of allergies to study medication or unable to tolerate antihistamines . 4. Use of study drugs in the last 3 days before baseline. 5. Subjects with significant systemic diseases, allergic conjunctivitis using steroid or antihistamine eye drops 6. Pregnant women and nursing mothers. 7. Patients with a history of any cardiovascular disease. 8. Patients on drugs impairing cognitive function. e.g. Alcohol, sedative, hypnotics 9. Patients requiring other modalities of treatment for severe Allergic rhinitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving clinical improvement/cure at the end of treatment w.r.t. Mean Total Symptom Score(absence of signs and symptoms such as runny nose, sneezing, itchy eyes, watery eyes etc.)Timepoint: Patients will be assessed at baseline and at 2 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Tolerability assessment evaluated by systematically recording & assessing all spontaneously reported adverse events from participants during 2 week treatment periodTimepoint: At baseline, at 1 week & at the end of 2 weeks;Proportion of patients showing improvement in Montreal Cognitive Assessment & Visual Analogue ScaleTimepoint: At baseline & at the end of 2 weeks | — |
Countries
India
Contacts
Public ContactDr Sairam Vasanthakumari Nagarajan
Governemnt Medicall College, Nagpur
Outcome results
None listed