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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