RECRUITING Not applicable ClinicalTrials.gov

Comparing Standard-Dose and High-Dose Cetirizine for Acute Urticaria

Sponsor: University of Phayao • ClinicalTrials.gov ID: NCT07236372

Registry updated: 2026-10-05

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

The goal of this clinical trial is to learn whether a higher dose of cetirizine works better than the standard dose to relieve symptoms of acute urticaria (hives) in adults. The study also aims to learn about the safety of taking a higher dose for a short period of time. The main questions the study aims to answer are: 1. Does the higher dose of cetirizine help people with acute urticaria improve faster than the standard dose? 2. What side effects do participants experience when taking the higher dose? Researchers will compare two groups: one group taking the standard dose of cetirizine (10 mg per day) and another group taking a higher dose (40 mg per day). This will help researchers understand which dose works better and whether the higher dose is safe. Participants will: Take the assigned study medication for 7 days Record their daily symptoms, including itch and hive severity Return for follow-up visits on Day 3, Day 7, and Week 6 Have blood tests to check liver and kidney function before and after treatment This study may help improve treatment options for people with acute urticaria and reduce the need for unnecessary steroid use.

Interventions

Cetirizine 10 mg once daily (Drug)
Participants in the standard-dose arm receive cetirizine 10 mg orally once daily for 7 days. The study medication is provided in capsule form to match the appearance of the high-dose capsules.
Cetirizine 20 mg twice daily, total 40 mg/day (Drug)
Participants in the high-dose arm receive cetirizine 20 mg orally twice daily (total 40 mg/day) for 7 days. The study medication is provided in capsule form to ensure identical appearance between arms.

Eligibility criteria

Inclusion Criteria: * Adults aged 18 to 60 years * Clinical diagnosis of acute urticaria made by a physician * Onset of new wheals within the past 24 hours * Able and willing to comply with study procedures, complete symptom diaries, and attend follow-up visits * Provides written informed consent prior to participation Exclusion Criteria: * Use of systemic corticosteroids within the past 5 days * Use of immunosuppressive medications within the past 5 days * Clinical signs of anaphylaxis, including respiratory distress, hypotension, abdominal pain, or acute laryngeal swelling * Presence of angioedema without wheals * Known diagnosis of chronic urticaria * Known severe renal impairment (creatinine clearance \<10 mL/min), heart failure (ejection fraction \<40%), or hepatic failure * Other skin conditions that may interfere with assessment (e.g., atopic dermatitis, eczema, bullous pemphigoid, AGEP) * Use of ACE inhibitors or ARBs within the past 5 days * Known allergy or hypersensitivity to cetirizine or components of the study medication * Pregnancy or breastfeeding * Known diabetes mellitus * History of gastrointestinal ulcer disease * Any condition that, in the investigator's judgment, would interfere with study participation or safety * Declines to provide informed consent

Conditions

Acute Urticaria

Locations

University of Phayao Hospital — Phayao, Mueang, Thailand

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment