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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

Effectiveness and safety of levocetirizine 10 mg versus combination of levocetirizine 5 mg plus montelukast 10 mg in chronic urticaria resistant to levocetirizine 5mg: A double blind, randomised, controlled, trial - LMRCT

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/12/005261
Enrollment
120
Registered
2014-12-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Intervention1: levocetirizine 10mg: levocetirizine 10mg will be given for 4 weeks daily at night Control Intervention1: levocetirizine 5mg with montelukast 10 mg: levocetirizine 5mg with montelukast 1

Sponsors

Medical College Kolkata
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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. 1. By urticaria severity score(uss) 2. By total severity score(tss) B.To compare the safety of the two treatments. 1. By laboratory method 2. By checklist the adverse effectsTimepoint: A. Baseline and End of 1st wk, 2nd wk, 3rd wk &4th wk B. 1.Baseline and post treatment value

Secondary

MeasureTime frame
A.To estimate the cost of therapy of the two groups. B.To compare the quality of life in both the treatment arms. Timepoint: Baseline and end of 4th week.

Countries

India

Contacts

Public ContactDr Amrita Sil

Medical College Hospital

tks.nrs@gmail.com9433543508

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 9, 2026