None listed
Conditions
Interventions
Intervention1: Hydroxyzine Sustained release tablet: 75 mg once daily for 4 weeks
Control Intervention1: Hydroxyzine immediate release tablet: 25 mg three times daily for 4 weeks
Sponsors
Sun Pharmaceutical Industries Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged from 18 to 65 years. 2. Patients having minimum 6 weeks history of chronic idiopathic urticaria and were experiencing an active flare. 3. Patient willing to give their informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control. 2. Patients having hypersensitivity to Hydroxyzine. 3. Patients taking pharmacological agents that could interfere with the study drug or interpretation of efficacy. 4. Patients with asthma using leukotriene inhibitors or those requiring chronic inhaled or systemic corticosteroid therapies. 5. Patients with uncontrolled hypertension and/or diabetes. 6. Alcohol abused patients. 7. Patients having porphyria. 8. Patients with renal and hepatic failure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average change from baseline in following parameters: 1. Severity of pruritus over last 24 hours. 2. Rating of number of wheals. 3. Rating of average size of the wheals. 4. Rating of duration of pruritus per day. Timepoint: Baseline Visit (day 0), week 2 and week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of rating of sleep disturbance (difficulty in falling asleep due to itch, awakening due to itch, use of sleep medication). 2. Average change from baseline in Clinical Global Impression on Severity (CGI-S). 3. Evaluation of Clinical Global Impression on Improvement (CGI-I).Timepoint: 1. Baseline Visit (day 0), week 2 and week 4 2. Baseline Visit (day 0) and week 4 3. week 2 and week 4 | — |
Countries
India
Contacts
Public ContactDr. Surendra Borgharkar
Outcome results
None listed