Health Condition 1: L501- Idiopathic urticaria
Conditions
Interventions
Intervention1: Bilastine: 40mg,Once daily,Oral for 28 days
Control Intervention1: Levocetirizine: 10mg,Once daily,Oral for 28 days
Sponsors
Rajendra institute of medical sciences
Eligibility
Inclusion criteria
Inclusion criteria: i. Patients with documented history of Chronic urticaria occurring >3 times/week for 8 weeks and an individual urticaria severity score of >2 for two urticaria symptoms for >3 days during the last 7 days screening period on the first visit day in OPD without any known inducible factor or definite cause. ii. Both sex. iii. Patients who give their informed written consent.
Exclusion criteria
Exclusion criteria: i. Pregnant and lactating women. ii. Any evidence of immunosuppression (eg. HIV infection, organ transplantation, long term steroid use etc.). iii. Any other prediagnosed systemic disease (eg. liver or kidney disorder). iv. Patients on any other form of treatment for any systemic diseases. v. Patients having prediagnosed Psychological conditions. vi. Patients with any form of inducible urticaria, known type of HS1, hereditary angioedema, known c1 esterase deficiency, urticaria associated with any malignancy or after acute or chronic infections vii. Patients having prediagnosed allergy to either of the study medications. viii. Patients working in night shifts or likely to change the usual sleep/wake cycle, those driving automobiles. ix. Patient’s participation in a clinical trial in the last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the clinical effectiveness and safety of bilastine 40mg and levocetirizine 10mg in CSU. Timepoint: Day 0, 14 AND 28TH OF MEDICINE ADMINISTRATION AFTER PRELIMINARY URTICARIA SCORING of medicine administration after preliminary urticaria scoring | — |
Secondary
| Measure | Time frame |
|---|---|
| 2 To determine the Safety and Tolerability of bilastine 40mg and levocetirizine 10mg in patients with CSU on the basis of treatment emergent adverse events (TEAEs).Timepoint: ANYTIME THROUGHOUT TREATMENT;To determine the Dermatological Quality Life Index (DLQI) in patient with CSU taking bilastine 40mg and levocetirizine 10mg.Timepoint: DAY 0 AND 28TH OF MEDICINE ADMINISTRATION;To determine the Urticaria Control Test (UCT) in patient with CSU taking bilastine 40mg and levocetirizine 10mg.Timepoint: DAY 0 AND 28TH OF MEDICINE ADMINISTRATION;To evaluate the urticaria induced global discomfort using Chronic Urticaria Quality of Life (CU Q2oL) questionnaire in patient with CSU taking bilastine 40mg and levocetirizine 10mg.Timepoint: DAY 0 AND 28TH OF MEDICINE ADMINISTRATION | — |
Countries
India
Contacts
Public ContactHrishikesh Chandran
Rajendra institute of medical sciences
Outcome results
None listed