Comparative Efficacy of Standard-Dose Versus Updosed Cetirizine in Acute Urticaria: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Time to Resolution of Acute Urticaria Symptoms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Time to Resolution of Acute Urticaria Symptoms
时间窗: From Day 0 (first dose) to Day 7 or until complete symptom resolution, whichever occurs first.
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.
Change in Urticaria Activity Score From Baseline
时间窗: Baseline to Day 7
The change in total UAS7 score from baseline to Day 7, based on daily patient-reported wheal and itch scores collected in symptom diaries.
次要结局
- Use of Systemic Corticosteroids as Rescue Medication(Day 0 to Day 7)
- Change in Dermatology Life Quality Index (DLQI)(Baseline to Day 7)
- Incidence and Characteristics of Adverse Events(Day 0 to Day 7 and Week 6 follow-up)
研究者
Wasuchon Chaichan
Lecturer, Department of Internal Medicine, School of Medicine, University of Phayao
University of Phayao