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

NCT ID: NCT03293225

Last Updated: 2019-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-24

Study Completion Date

2019-05-24

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

Conditions

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Chronic Urticaria

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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add H2RA

Add antihistamines to standard drug therapy

No interventions assigned to this group

change ns-H1RA

Change to ns-H1RA in standard medication

No interventions assigned to this group

ns-H1RA(3-4 tabs)

Standard treatment with ns-H1RA 4X dose

No interventions assigned to this group

ns-H1RA(3-4kinds)

Use of NS 4 kinds for standard treatment

No interventions assigned to this group

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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ajou University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Ye Youngmin

professor, Department alleric internal medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Youngmin Ye, Dr

Role: STUDY_DIRECTOR

Ajou University

Locations

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Ajou University Medical Hospital

Suwon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AJIRB-MED-OBS-17-173

Identifier Type: -

Identifier Source: org_study_id

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