Evaluation of Pharmacological Treatments for Acute Urticaria: A Systematic Review and Meta-Analysis.
Sirinda Jamjanya, Pojsakorn Danpanichkul, Sorawit Ongsupankul...
https://pubmed.ncbi.nlm.nih.gov/38280453Actively Recruiting
Phase Not Applicable
Age: 18Years - 60Years
All Genders
ID07236372
Comparative Efficacy of Standard-Dose Versus Updosed Cetirizine in Acute Urticaria: A Randomized Controlled Trial
Led by University of Phayao · Updated on 2026-06-03
140
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether a higher dose of cetirizine provides better relief than the standard dose for adults with acute urticaria, a condition causing sudden itchy wheals. This clinical trial aims to understand if increasing cetirizine to 40 mg daily improves symptoms faster and is safe over a short period. The study also explores side effects and helps reduce unnecessary steroid use in treating this condition. Participants are randomly assigned to one of two groups: one taking the standard 10 mg dose once daily, and the other taking a higher 40 mg dose split into two 20 mg capsules daily. Both groups take their assigned medication for 7 days, recording their daily symptoms. Follow-up visits occur on Day 3, Day 7, and Week 6 to assess symptom improvement and safety. The study uses capsules that look identical to maintain fairness. Before and after treatment, participants have blood tests to check liver and kidney function. Researchers monitor symptoms using validated tools and track the need for rescue medications like corticosteroids. The main outcomes focus on how quickly symptoms resolve and changes in urticaria activity. The study lasts through the follow-up at Week 6 to observe longer-term effects and any recurrence of symptoms.
CONDITIONS
Brief Title
Comparing Standard-Dose and High-Dose Cetirizine for Acute Urticaria
Who Can Participate
Age: 18Years - 60Years
All Genders
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 7 days
Participants receive either a standard dose or a higher dose of cetirizine daily for 7 days to relieve symptoms of acute urticaria. They record their daily symptoms and are monitored for side effects.
Daily symptom recording and scheduled follow-up visits during treatment
Follow-up
Duration - Up to 6 weeks after treatment
Participants attend follow-up visits to assess symptom improvement, need for rescue medications, side effects, and potential recurrence or progression of urticaria.
Follow-up visits after treatment completion
Trial Site Locations
Total: 1 location
1
University of Phayao Hospital
Phayao, Mueang, Thailand, 56000
Actively Recruiting
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Research Team
W
Wasuchon Chaichan, MD
C
Chonlawat Chaichan, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Efficacy and Safety of Systemic Corticosteroids for Urticaria: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.
Xiajing Chu, Jason Wang, Leonardo Ologundudu...
https://pubmed.ncbi.nlm.nih.gov/38642709Treatment of acute urticaria: A systematic review.
Fariza M S Badloe, Martine Grosber, Johannes Ring...
https://pubmed.ncbi.nlm.nih.gov/38420865Double dose of cetirizine hydrochloride is effective for patients with urticaria resistant: a prospective, randomized, non-blinded, comparative clinical study and assessment of quality of life.
Yukari Okubo, Yukie Shigoka, Masashi Yamazaki...
https://pubmed.ncbi.nlm.nih.gov/21810005The international EAACI/GA²LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria.
Torsten Zuberbier, Amir Hamzah Abdul Latiff, Mohamed Abuzakouk...
https://pubmed.ncbi.nlm.nih.gov/34536239