Health Condition 1: L501- Idiopathic urticaria
Conditions
Interventions
Intervention1: Bilastine: Bilastine is second generation H-1 antihistamine approved for the treatment of chronic spontaneous urticaria which was previously known as chronic idiopathic urticaria.It was
Sponsors
Dr Vishakha Sinha
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18-65 years, literate of either gender who are willing to participate in the study by signing a written informed consent. 2.Subjects giving history of urticarial wheal for at least 3 days a week for 6 consecutive weeks with no obvious cause prior to inclusion in study. 3.Subjects having a mean total symptom score more than equal to 3 at screening. This includes 1-5 number of wheal score more than equal to 1 at least a moderate severity of pruritus score of 2. 4.Those who understand and agree to adhere to the dosing visit schedules assess and record their symptoms severity score, concomitant medications and adverse events and other details accurately and consistently in a daily dairy. 5.Patients with normal ECG
Exclusion criteria
Exclusion criteria: 1. History of asthma or any other disease requiring chronic use of inhaled or systemic corticosteroids. 2. History of allergies to study medication or unable to tolerate antihistamines. 3. Subjects with acute urticaria or with other known aetiology. 4. Pregnant women and nursing mothers. 5. Subjects with significant hematopoietic, cardiovascular, hepatic and renal disorder. 6. History suggestive of neurologic, psychiatric or autoimmune diseases. 7. Patients suffering from any other systemic illness. 8. Patients on concomitant drug therapy like antihistamines, corticosteroids (topical and oral) and CNS depressants like sedatives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in the mean total score (MTSS) at baseline and six weeks. Timepoint: 0 and 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change for interference of wheals with sleepTimepoint: 0 and 6 weeks;Change in pruritus scale.Timepoint: 0 and 6 weeks;Change in scale for extent of skin area involvement (SESI).Timepoint: 0 and 6 weeks;Change in scale for intensity of erythemaTimepoint: 0 and 6 weeks;Change in scale for size of wheal.Timepoint: 0 and 6 weeks;Change in visual analogue scale (VAS) for sedationTimepoint: 0 and 6 weeks;Changes in scale of number of whealsTimepoint: 0 and 6 weeks | — |
Countries
India
Contacts
Public ContactDrVishakha Sinha
Government Medical College, Nagpur
Outcome results
None listed