Comparison of safety and usefulness of levocetrizine tablet and bepotastine tablet in patients suffering from hives for more than 6 weeks
Phase 4
- Conditions
- Health Condition 1: null- Chronic urticaria
- Registration Number
- CTRI/2018/05/013729
- Lead Sponsor
- Institutional
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method rticaria Activity Score 7 (UAS 7)Timepoint: 0 2 4 6 8 10 12 16 20 24 weeks
- Secondary Outcome Measures
Name Time Method 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