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Clinical study of levocetirizine hydrochloride in the treatment of urticaria in young children

Clinical study of levocetirizine hydrochloride in the treatment of urticaria in young children

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300073202
Enrollment
Unknown
Registered
2023-07-04
Start date
2023-10-01
Completion date
Unknown
Last updated
2023-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

urticaria

Interventions

observation group (Take levocetirizine hydrochloride oral solution, once a night, 1.25mg (2.5ml) each time, acute urticaria for 7 consecutive days, chronic urticaria for 28 consecutive days):None

Sponsors

Children's Hospital ZheJiang Univisity School Of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0.5 Years to 2 Years

Inclusion criteria

Inclusion criteria: ( 1 ) Age 6 months to 2 years ( including boundary age ), gender unlimited ( 2 ) According to the ' Clinical Pathway Interpretation · Dermatology and Venereal Diseases ( 2022 Edition ) ' diagnostic criteria for urticaria, children with clinically diagnosed urticaria : A ) The rash is a wheal of different size, shape and quantity, which occurs suddenly and subsides rapidly. b ) The existence time of single damage is generally less than 24 hours, and there is no trace after regression. c ) The rash has no fixed predilection site, often accompanied by varying degrees of itching, a few with tingling. d ) The course of disease was different. Acute urticaria was within 6 weeks, and chronic urticaria was more than 6 weeks. ( 3 ) Able to obtain the written consent of the guardian ( 4 ) The guardian can write a diary on behalf of the children.

Exclusion criteria

Exclusion criteria: ( 1 ) Children with allergies to levocetirizine hydrochloride preparations or piperazine derivatives such as hydroxylazine, cetirizine, and cycloazine or children with a history of allergies. ( 2 ) Children with chest tightness or dyspnea, nausea, vomiting, abdominal pain, and diarrhea. ( 3 ) Children who are using a prohibited combination of drugs ( systemic glucocorticoid drugs, omalizumab, cyclosporine and other antihistamine drugs, montelukast, compound glycyrrhizin, systemic antibiotic drugs, and other drugs that are judged by other researchers to affect the determination of test efficacy indicators ). ( 4 ) Children with chronic urticaria who were treated with loratadine and desloratadine within 7 days before the start of the treatment period and other antihistamines within 3 days. Children who had been treated with systemic glucocorticoids, omalizumab, cyclosporine, and compound glycyrrhizin within 30 days. ( 5 ) If breastfed, mothers had children who took antihistamines and glucocorticoids during the trial. ( 6 ) Children with mental illness, immune system disease, blood system disease, systemic infectious disease, and malignant tumor. ( 7 ) Researchers judged that children who were not suitable for inclusion in this study.

Design outcomes

Primary

MeasureTime frame
adverse event;UAS;

Secondary

MeasureTime frame
quality of life score;

Countries

China

Contacts

Public ContactRen yunqing

Children's Hospital ZheJiang Univisity School Of Medicine

yqren@zju.edu.cn+86 135 0681 2699

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026