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

NCT ID: NCT07236372

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2026-10-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Standard-Dose Cetirizine (10 mg/day)

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.

Group Type: ACTIVE_COMPARATOR

Cetirizine 10 mg

Intervention Type: DRUG

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.

Updosed Cetirizine (40 mg/Day)

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.

Group Type: EXPERIMENTAL

Cetirizine 40 mg

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Use of systemic corticosteroids within the past 5 days
• Use of antihistamines 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Phayao

OTHER

Sponsor Role: lead

Responsible Party

Wasuchon Chaichan

Lecturer, Department of Internal Medicine, School of Medicine, University of Phayao

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wasuchon Chaichan

Role: PRINCIPAL_INVESTIGATOR

School of Medicine, University of Phayao

Locations

University of Phayao Hospital

Phayao, Muang, Thailand

Countries

Thailand

Central Contacts

Wasuchon Chaichan, MD

Role: CONTACT

wasuchon.ch@gmail.com

+6654466666 ext. 7020

Chonlawat Chaichan, Msc

Role: CONTACT

Chonlawat.chaichan@gmail.com

Facility Contacts

Wasuchon Chaichan, MD

Role: primary

wasuchon.ch@gmail.com

+665446666 ext. 7020

Chonlawat Chaichan

Role: backup

Chonlawat.chaichan@gmail.com

References

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Other Identifiers

MD68-19

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HREC-UP-HSST 1.3/002/69

Identifier Type: -

Identifier Source: org_study_id