Comparison of two drugs cetrizine and bilastine in patients of urticaria
- Conditions
- Health Condition 1: L501- Idiopathic urticaria
- Registration Number
- CTRI/2020/05/025031
- Lead Sponsor
- Dr Vishakha Sinha
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 63
1. Subjects aged 18-65 years, literate of either gender who are willing to participate in the study by signing a written informed consent.
2.Subjects giving history of urticarial wheal for at least 3 days a week for 6 consecutive weeks with no obvious cause prior to inclusion in study.
3.Subjects having a mean total symptom score more than equal to 3 at screening. This includes 1-5 number of wheal score more than equal to 1 at least a moderate severity of pruritus score of 2.
4.Those who understand and agree to adhere to the dosing visit schedules assess and record their symptoms severity score, concomitant medications and adverse events and other details accurately and consistently in a daily dairy.
5.Patients with normal ECG
1.History of asthma or any other disease requiring chronic use of inhaled or systemic corticosteroids.
2.History of allergies to study medication or unable to tolerate antihistamines.
3.Subjects with acute urticaria or with other known aetiology.
4.Pregnant women and nursing mothers.
5.Subjects with significant hematopoietic, cardiovascular, hepatic and renal disorder.
6.History suggestive of neurologic, psychiatric or autoimmune diseases.
7.Patients suffering from any other systemic illness.
8.Patients on concomitant drug therapy like antihistamines, corticosteroids (topical and oral) and CNS depressants like sedatives.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in the mean total score (MTSS) at baseline and six weeks. <br/ ><br> <br/ ><br>Timepoint: 0 and 6 weeks <br/ ><br>
- Secondary Outcome Measures
Name Time Method Change for interference of wheals with sleepTimepoint: 0 and 6 weeks;Change in pruritus scale.Timepoint: 0 and 6 weeks;Change in scale for extent of skin area involvement (SESI).Timepoint: 0 and 6 weeks;Change in scale for intensity of erythemaTimepoint: 0 and 6 weeks;Change in scale for size of wheal.Timepoint: 0 and 6 weeks;Change in visual analogue scale (VAS) for sedationTimepoint: 0 and 6 weeks;Changes in scale of number of whealsTimepoint: 0 and 6 weeks