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

Recruiting now · Not applicable

Conditions studied: Acute Urticaria

In brief

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.

Key facts

Study ID

NCT07236372

Run by

University of Phayao

People needed

140

Starts

2025-11-15

Expected to finish

2026-10-01

Last updated by the study team

2026-06-03

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Phayao Hospital — Phayao, Mueang, Thailand (enrolling)

Full record on ClinicalTrials.gov

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