Comparing Standard-Dose and High-Dose Cetirizine for Acute Urticaria
ConditionAcute Urticaria
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Phayao
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Cetirizine 10 mg once daily
DrugParticipants 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
DrugParticipants 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.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Standard-dose cetirizine 10 mg orally once dailyActive comparator 1 intervention
Group B: Updosed Cetirizine 40 mg/dayExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Time to Resolution of Acute Urticaria Symptoms
The time from the first dose of study medication to the complete resolution of acute urticaria symptoms, defined as the absence of hives and an itch score of 0 for at least 24 consecutive hours. Symptom status will be assessed using patient-reported daily symptom diaries and validated scoring tools.
Time frame
From Day 0 (first dose) to Day 7 or until complete symptom resolution, whichever occurs first.2
Change in Urticaria Activity Score From Baseline
The change in total UAS7 score from baseline to Day 7, based on daily patient-reported wheal and itch scores collected in symptom diaries.
Time frame
Baseline to Day 7Secondary outcomes
1
Use of Systemic Corticosteroids as Rescue Medication
The proportion of participants requiring systemic corticosteroids due to persistent or worsening acute urticaria symptoms despite taking the assigned study medication.
Time frame
Day 0 to Day 72
Change in Dermatology Life Quality Index (DLQI)
The change in Dermatology Life Quality Index (DLQI) from baseline to Day 7 to assess the clinical response and quality of life impact of treatment.
Time frame
Baseline to Day 73
Incidence and Characteristics of Adverse Events
Number, type, and severity of adverse events occurring during treatment with standard-dose versus high-dose cetirizine. Adverse events may include sedation, dizziness, or other treatment-related symptoms.
Time frame
Day 0 to Day 7 and Week 6 follow-upSponsors and contacts
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Source ClinicalTrials.gov