CTRI/2023/10/059058
Recruiting
Phase 3
A COMAPRATIVE STUDY ON THE CLINICAL EFFECTIVENESS AND SAFETY BETWERN BILASTINE 40MG VS LEVOCETIRIZINE 1OMG IN PATIENTS WITH CHRONIC SPONTANEOUS URTICARIA: A OPEN LABEL, PARALLEL GROUP, BLINDED END POINT ASSESSMENT RANDOMISED CONTROL TRIAL - NI
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: L501- Idiopathic urticaria
- Sponsor
- Rajendra institute of medical sciences
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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