Comparison of safety and efficaccy of levocetrizine and olopatadine in patients suffering from hives for more than 6 weeks

Phase 4

Completed

• Conditions: Chronic Urticaria

• Registration Number: CTRI/2011/08/001965
• Lead Sponsor: Burdwan Medical College and Hospital

Brief Summary

Patients of chronic  urticaria having symptoms of itching, wheals > 6 weeks were screened according to inclusion/exclusion criteria were randomly allocated oral trial medications (either olopatadine tablets 5 mg or levocetrizine tablets 5 mg) continously for 4 weeks and then on as and when needed basis for another 5 weeks. The effects of the above mentioned antihistamines were recorded with respect to decrease/increase in symtoms. Scoring systems used were Urticaria activity score (UAS), Urticaria total severity score (TSS), Patients’ and Physicians’ global assessment of disease activity improvement (5 point Likert scale). The scores were recorded at 1, 2, 3, 4, 5, 9 weeks after randomisation.

Safety data were collected with respect to baseline and 4th follow-up laboratory values of routine haemogram, LFT, serum urea, creatinine, blood glucose. Also adverse effects were recorded.

Our study hypothesis was that levocetrizine and olopatadine were equally efficacious in the treatment of patients with chronic urticaria.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-03
• Last Update Posted: 2014-06-19

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Age above 18 years 2.
• Patients of either sex 3.
• Patients suffering from urticaria for more than 6 weeks.

Exclusion Criteria

• 1Pregnant or nursing women 2End stage renal disease 3Patients having immunosuppression due to drug or disease 4History of alcohol or substance abuse 5Subjects working in night-shifts or are likely to change the usual sleep/wake cycle.
• 6Patients driving automobiles.
• 7Participation in any other clinical trial within past 3 months 8Patients unwilling to provide written informed consent or unlikely to comply with the trial protocol 9Any other condition, which in the opinion of the investigators, is not conducive to inclusion of the subject in the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Urticaria Severity Score(UAS)	4,9 weeks after randomisation
Total Symptom Severity Score (TSS),	4,9 weeks after randomisation
Patients and Physicians global assessment of disease activity improvement (5 point Likert scale)	4,9 weeks after randomisation

Secondary Outcome Measures

Name	Time	Method
LFT	Routine haemogram

Trial Locations

Locations (1)

Burdwan Medical College and Hospital; 🇮🇳 Barddhaman, WEST BENGAL, India

Burdwan Medical College and Hospital

🇮🇳Barddhaman, WEST BENGAL, India

Amrita Sil

Principal investigator

09477737091

drsilamrita@gmail.com