NCT07236372

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

Comparative Efficacy of Standard-Dose Versus Updosed Cetirizine in Acute Urticaria: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: University of Phayao · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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: Does the higher dose of cetirizine help people with acute urticaria improve faster than the standard dose? 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.

Detailed description

This study is a randomized, parallel-group clinical trial designed to evaluate whether a higher dose of cetirizine provides better symptom relief than the standard dose in adults with acute urticaria. Acute urticaria often causes sudden wheals and intense itching that can significantly affect comfort and daily functioning. Although standard-dose second-generation antihistamines are recommended as first-line treatment, many people do not fully improve and are frequently prescribed systemic corticosteroids, which may lead to unnecessary side effects. This trial investigates whether increasing the dose of cetirizine to 40 mg per day offers faster or more complete symptom improvement without increasing safety risks. Participants will be randomly assigned to receive either the standard dose or the higher dose for 7 days. The study uses a blinded outcome assessment to minimize bias. Symptom severity will be measured using validated tools, and participants will be monitored for side effects throughout the study. Laboratory tests will be used to assess kidney and liver function before and after treatment. Follow-up visits will evaluate short-term changes in symptoms as well as the potential for recurrence or progression to chronic urticaria. The findings may help guide clinical decision-making and support more rational use of antihistamines while reducing reliance on corticosteroids in acute urticaria care.

Conditions

• Acute Urticaria

Interventions

Type	Name	Description
DRUG	Cetirizine 10 mg	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.
DRUG	Cetirizine 40 mg	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.

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-06-01
• Completion: 2026-10-01
• First posted: 2025-11-19
• Last updated: 2025-11-19

Locations

1 site across 1 country: Thailand