[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611114":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":40,"studyPopulation":29,"armGroups":41,"interventions":54,"overallOfficials":64,"centralContacts":69,"locations":79,"responsibleParty":102,"collaborators":29,"id":104,"slug":29,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":105,"sex":111,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":29,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":82,"whyStopped":29,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"University of Phayao","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":29},[9,13],{"measure":10,"description":11,"timeFrame":12},"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.","From Day 0 (first dose) to Day 7 or until complete symptom resolution, whichever occurs first.",{"measure":14,"description":15,"timeFrame":16},"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.","Baseline to Day 7",[18,22,25],{"measure":19,"description":20,"timeFrame":21},"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.","Day 0 to Day 7",{"measure":23,"description":24,"timeFrame":16},"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.",{"measure":26,"description":27,"timeFrame":28},"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.","Day 0 to Day 7 and Week 6 follow-up",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":33,"primaryPurpose":34,"observationalModel":29,"timePerspective":29,"maskingInfo":35},"RANDOMIZED","PARALLEL","This study uses a randomized, parallel-group design in which participants are assigned in a 1:1 ratio to receive either the standard dose or the high dose of cetirizine. A blinded outcome assessor evaluates symptom improvement to minimize measurement bias. The intervention lasts 7 days, followed by scheduled follow-up visits to assess symptom resolution, recurrence, and safety outcomes.","TREATMENT",{"masking":36,"maskingDescription":29,"whoMasked":37},"DOUBLE",[38,39],"PARTICIPANT","OUTCOMES_ASSESSOR","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.\n\nThis 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.\n\nLaboratory 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.",[42,48],{"label":43,"type":44,"description":45,"interventionNames":46},"Standard-dose cetirizine 10 mg orally once daily","ACTIVE_COMPARATOR","Participants in this arm will receive standard-dose cetirizine at 10 mg once daily for 7 days. The medication will be provided in capsule form. Participants will record their daily urticaria symptoms and return for scheduled follow-up visits to assess symptom improvement and safety outcomes.",[47],"Drug: Cetirizine 10 mg once daily",{"label":49,"type":50,"description":51,"interventionNames":52},"Updosed Cetirizine 40 mg\u002Fday","EXPERIMENTAL","Participants in this arm will receive high-dose cetirizine at 40 mg per day, taken as 20 mg twice daily for 7 days. The medication will be provided in capsule form. Participants will record their daily urticaria symptoms and return for scheduled follow-up visits to assess symptom improvement, the need for rescue medications, and any side effects.",[53],"Drug: Cetirizine 20 mg twice daily, total 40 mg\u002Fday",[55,60],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":29},"DRUG","Cetirizine 10 mg once daily","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.",[43],{"type":56,"name":61,"description":62,"armGroupLabels":63,"otherNames":29},"Cetirizine 20 mg twice daily, total 40 mg\u002Fday","Participants in the high-dose arm receive cetirizine 20 mg orally twice daily (total 40 mg\u002Fday) for 7 days. The study medication is provided in capsule form to ensure identical appearance between arms.",[49],[65],{"name":66,"affiliation":67,"role":68},"Wasuchon Chaichan","School of Medicine, University of Phayao","PRINCIPAL_INVESTIGATOR",[70,76],{"name":71,"role":72,"phone":73,"phoneExt":74,"email":75},"Wasuchon Chaichan, MD","CONTACT","+6654466666","7020","wasuchon.ch@gmail.com",{"name":77,"role":72,"phone":29,"phoneExt":29,"email":78},"Chonlawat Chaichan, MSc","Chonlawat.chaichan@gmail.com",[80],{"facility":81,"status":82,"city":83,"state":84,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"University of Phayao Hospital","RECRUITING","Phayao","Mueang","56000","Thailand","TH",{"type":89,"coordinates":90},"Point",[91,92],99.87883,19.19203,{"lat":92,"lon":91},[95,96,98,99],{"name":71,"role":72,"phone":73,"phoneExt":74,"email":75},{"name":97,"role":72,"phone":29,"phoneExt":29,"email":78},"Chonlawat Chaichan",{"name":71,"role":68,"phone":29,"phoneExt":29,"email":29},{"name":100,"role":101,"phone":29,"phoneExt":29,"email":29},"Petcharaporn Chachvarat, MD","SUB_INVESTIGATOR",{"type":68,"investigatorFullName":66,"investigatorTitle":103,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Lecturer, Department of Internal Medicine, School of Medicine, University of Phayao","100611114",false,"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","CURE-AU","Inclusion Criteria:\n\n* Adults aged 18 to 60 years\n* Clinical diagnosis of acute urticaria made by a physician\n* Onset of new wheals within the past 24 hours\n* Able and willing to comply with study procedures, complete symptom diaries, and attend follow-up visits\n* Provides written informed consent prior to participation\n\nExclusion Criteria:\n\n* Use of systemic corticosteroids within the past 5 days\n* Use of immunosuppressive medications within the past 5 days\n* Clinical signs of anaphylaxis, including respiratory distress, hypotension, abdominal pain, or acute laryngeal swelling\n* Presence of angioedema without wheals\n* Known diagnosis of chronic urticaria\n* Known severe renal impairment (creatinine clearance \\\u003C10 mL\u002Fmin), heart failure (ejection fraction \\\u003C40%), or hepatic failure\n* Other skin conditions that may interfere with assessment (e.g., atopic dermatitis, eczema, bullous pemphigoid, AGEP)\n* Use of ACE inhibitors or ARBs within the past 5 days\n* Known allergy or hypersensitivity to cetirizine or components of the study medication\n* Pregnancy or breastfeeding\n* Known diabetes mellitus\n* History of gastrointestinal ulcer disease\n* Any condition that, in the investigator's judgment, would interfere with study participation or safety\n* Declines to provide informed consent","ALL","18 Years","60 Years",{"count":115,"type":116},140,"ESTIMATED","INTERVENTIONAL",[119],"NA","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:\n\n1. Does the higher dose of cetirizine help people with acute urticaria improve faster than the standard dose?\n2. What side effects do participants experience when taking the higher dose?\n\nResearchers will compare two groups:\n\none 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.\n\nParticipants will:\n\nTake 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\n\nThis study may help improve treatment options for people with acute urticaria and reduce the need for unnecessary steroid use.",[122],"Acute Urticaria",[122,124,125,126,127,128],"Updosed Cetirizine","High-Dose Antihistamine","Standard-Dose Cetirizine","Second-Generation Antihistamine","Randomized Controlled Trial","2026-05-31",{"date":131,"type":132},"2026-06-03","ACTUAL",{"date":134,"type":132},"2025-11-15",{"date":136,"type":116},"2026-10",{"name":5,"class":6},1]