Efficacy of Antihistamine Dosing-up and add-on Treatment With H2-receptor Antagonist
Overview
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
Full Title of Study: “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”
Study Type
- Study Type: Observational [Patient Registry]
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: May 24, 2019
Detailed Description
– 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
Arms, Groups and Cohorts
- add H2RA
- Add antihistamines to standard drug therapy
- change ns-H1RA
- Change to ns-H1RA in standard medication
- ns-H1RA(3-4 tabs)
- Standard treatment with ns-H1RA 4X dose
- ns-H1RA(3-4kinds)
- Use of NS 4 kinds for standard treatment
Clinical Trial Outcome Measures
Primary Measures
- Number of evaluation after 4 weeks treatment by a investigator
- Time Frame: 4 weeks
- 0-no effective, 1-ineffective, 2-effective, 3-no symptoms
Secondary Measures
- Peripheral blood eosinophil count
- Time Frame: 4 weeks
- in percentage
- Number of evaluation as assessed by questionnaire
- Time Frame: 4 weeks
- Sleepiness, dryness, dysuria
- Number of urticaria control by K-UCT
- Time Frame: 4 weeks
- Before and after treatment
- Number of urticaria symptom by UAS
- Time Frame: 4 weeks
- Urticaria activity score
- Quality of life of chronic urticaria by CU-QoL
- Time Frame: 4 weeks
- Quality of life questionnaire for patients with chronic urticaria
- Number of Patient-controlled urticaria by VAS
- Time Frame: 4 weeks
- evaluation of Patient-controlled urticaria
- Number of patients using emergency medication
- Time Frame: 4 weeks
- Emergency drug frequency in patients with chronic urticaria
- Comparison of Serum total IgE
- Time Frame: 4 weeks
- Comparison each group in treatment activity
- Number of physiological parameter
- Time Frame: 4 weeks
- weight gain in kilograms
- Number of creatinine, AST/ALT
- Time Frame: 4 weeks
- Creatinine in mg/dl, AST/ALT in UL
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 12 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Ajou University School of Medicine
- Provider of Information About this Clinical Study
- Principal Investigator: Ye Youngmin, professor, Department alleric internal medicine – Ajou University School of Medicine
- Overall Official(s)
- Youngmin Ye, Dr, Study Director, Ajou University
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