Effectiveness and safety of levocetirizine 10 mg versus combination of levocetirizine 5 mg plus montelukast 10 mg in long standing hives not responding to levocetirizine 5mg
Phase 4
- Conditions
- Health Condition 1: null- All patients presenting with chronic urticaria aged above 18 years and symptoms not relieved by single daily dose of tab. levocetirizine 5mg for 2 weeks.
- Registration Number
- CTRI/2014/12/005261
- Lead Sponsor
- Medical College Kolkata
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
All patients presenting with chronic urticaria aged above 18 years and symptoms not responding to a single daily dose of second generation antihistamine (levocetirizine 5mg once daily dose) even after 2 weeks of therapy.
Exclusion Criteria
1.Pregnant and lactating females.
2.Patients having immunosuppression due to drug or disease.
3.Patients having end stage renal disease.
4.Patients allergic to levocetirizine, cetrizine or its parent compound hydroxyzine, montelukast.
5.Patients not consenting.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A.To assess the clinical effectiveness of montelukast 10 mg and levocetirizine 5 mg versus levocetirizine 10 mg in cases of CU not responding to 5mg levocetirizine. <br/ ><br> 1. By urticaria severity score(uss) <br/ ><br> 2. By total severity score(tss) <br/ ><br> <br/ ><br>B.To compare the safety of the two treatments. <br/ ><br> 1. By laboratory method <br/ ><br> 2. By checklist the adverse effectsTimepoint: A. Baseline and End of 1st wk, 2nd wk, 3rd wk &4th wk <br/ ><br> <br/ ><br>B. <br/ ><br> 1.Baseline and post treatment value
- Secondary Outcome Measures
Name Time Method A.To estimate the cost of therapy of the two groups. <br/ ><br>B.To compare the quality of life in both the treatment arms. <br/ ><br>Timepoint: Baseline and end of 4th week.