Efficacy of Antihistamine Dosing-up and add-on Treatment With H2-receptor Antagonist

Study Overview
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Brief Summary
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A randomized open labeled trial to compare the efficacy of antihistamine dosing-up and add-on treatment with H2-receptor antagonist in patients with chronic urticaria

Detailed Description
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For four weeks After the researcher confirms the selection / exclusion criteria on the baseline, the UAS, K-UCT, and CU-QoL are created and randomized from the subject. Receive UAS, K-UCT, and CU-QoL from the subject during the last visit to assess safety

Official Title
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A Randomized Open Labeled Trial to Compare the Efficacy of Antihistamine Dosing-up and add-on Treatment With H2-receptor Antagonist in Patients With Chronic Urticaria

Conditions
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Chronic Urticaria

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adolescents and adults over 12 years Clinical diagnosis of chronic urticaria due to wheal reaction, itching, angioedema over 6 weeks Antihistamine 2 or 2 kinds of treatment for more than 2 weeks even if the symptoms are not controlled Those who do not have other chronic skin diseases Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| add H2RA<br>Add antihistamines to standard drug therapy | |
| change ns-H1RA<br>Change to ns-H1RA in standard medication | |
| ns-H1RA(3-4 tabs)<br>Standard treatment with ns-H1RA 4X dose | |
| ns-H1RA(3-4kinds)<br>Use of NS 4 kinds for standard treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of evaluation after 4 weeks treatment by a investigator | 0-no effective, 1-ineffective, 2-effective, 3-no symptoms | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral blood eosinophil count | in percentage | 4 weeks | 
| Number of evaluation as assessed by questionnaire | Sleepiness, dryness, dysuria | 4 weeks | 
| Number of urticaria control by K-UCT | Before and after treatment | 4 weeks | 
| Number of urticaria symptom by UAS | Urticaria activity score | 4 weeks | 
| Quality of life of chronic urticaria by CU-QoL | Quality of life questionnaire for patients with chronic urticaria | 4 weeks | 
| Number of Patient-controlled urticaria by VAS | evaluation of Patient-controlled urticaria | 4 weeks | 
| Number of patients using emergency medication | Emergency drug frequency in patients with chronic urticaria | 4 weeks | 
| Comparison of Serum total IgE | Comparison each group in treatment activity | 4 weeks | 
| Number of physiological parameter | weight gain in kilograms | 4 weeks | 
| Number of creatinine, AST/ALT | Creatinine in mg/dl, AST/ALT in UL | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cu