Comparison of safety and usefulness of levocetrizine tablet and bepotastine tablet in patients suffering from hives for more than 6 weeks

A Single-Blind Randomised Controlled Clinical Study Comparing the Efficacy, Tolerability and Safety of Levocetrizine and Bepotastine in Chronic Urticaria

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/05/013729

Enrollment

Registered

2018-05-07

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- Chronic urticaria

Interventions

Intervention1: Bepotastine besilate: Tablet Bepotastine besilate 10 mg tablet orally twice daily for 3 months Control Intervention1: Levocetirizine: Tablet Levocetirizine 5 mg once daily orally for 3

Eligibility

Inclusion criteria

Inclusion criteria: Age 18 yrs to 85 years Near daily appearance of wheals for more than 6 weeks Urticaria Activity Score 7 (UAS 7) more than equal to 14 Informed consent obtained Willing for weekly follow-up and injections

Exclusion criteria

Exclusion criteria: Pregnant and lactating women Immunosuppressed due to drug or disease Allergy to Levocetirizine Concomitant systemic illness requiring treatment Mental illness interfering with perception of urticarial symptoms Subjects working in night shifts or are likely to change the usual sleep/ wake cycle Patients driving automobiles Participation in any clinical trial within the last 3 months Any other condition, which in the opinion of the investigators, is not conducive to inclusion of the subject in the trial Substance or alcohol abuse

Design outcomes

Primary

Measure	Time frame
Urticaria Activity Score 7 (UAS 7)Timepoint: 0 2 4 6 8 10 12 16 20 24 weeks	—

Secondary

Measure	Time frame
Adverse events (Spontaneously reported and those elicited by clinician)Timepoint: 2 4 6 8 10 12 16 20 24 weeks;Changes in LFT Serum Urea Creatinine Routine HeamogramTimepoint: 0 and 12 weeks;Patientsâ?? global assessment of disease activity improvement (5 point Likert scale)Timepoint: 0 2 4 6 8 10 12 16 20 24 weeks;Physiciansâ?? global assessment of disease activity improvement (5 point Likert scale)Timepoint: 0 2 4 6 8 10 12 16 20 24 weeks;Urticaria Activity Score (UAS)Timepoint: 0 2 4 6 8 10 12 16 20 24 weeks;Urticaria total severity score (TSS)Timepoint: 0 2 4 6 8 10 12 16 20 24 weeks	—

Measure

Time frame

Adverse events (Spontaneously reported and those elicited by clinician)Timepoint: 2 4 6 8 10 12 16 20 24 weeks;Changes in LFT Serum Urea Creatinine Routine HeamogramTimepoint: 0 and 12 weeks;Patientsâ?? global assessment of disease activity improvement (5 point Likert scale)Timepoint: 0 2 4 6 8 10 12 16 20 24 weeks;Physiciansâ?? global assessment of disease activity improvement (5 point Likert scale)Timepoint: 0 2 4 6 8 10 12 16 20 24 weeks;Urticaria Activity Score (UAS)Timepoint: 0 2 4 6 8 10 12 16 20 24 weeks;Urticaria total severity score (TSS)Timepoint: 0 2 4 6 8 10 12 16 20 24 weeks

—

Countries

India

Contacts

Public ContactProf Nilay Kanti Das

Bankura Sammilani Medical College

drdasnilay@gmail.com9433394148

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026