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The Delay from Symptom Onset to Diagnosis in Chronic Urticaria: A Comprehensive Study on Influencing Factors, Patient Experiences, and Strategies for Optimizing Diagnostic Pathways

The Delay from Symptom Onset to Diagnosis in Chronic Urticaria: A Comprehensive Study on Influencing Factors, Patient Experiences, and Strategies for Optimizing Diagnostic Pathways

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114907
Enrollment
Unknown
Registered
2025-12-18
Start date
2025-12-18
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Chronic Spontaneous Urticaria

Interventions

Observation group:None

Sponsors

The General Hospital of Western Theater Command
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Age: 18 - 80 years old, gender not restricted; 2) Confirmed as CSU by the dermatology department of the Western Theater Command General Hospital, in accordance with the guidelines of EAACI/GA²LEN/EuroGuiDerm/APAAACI (symptoms lasting >= 6 weeks, without clear external triggering factors); 3) Medical records or questionnaires provide the onset time and the time of diagnosis, allowing for the calculation of diagnostic delay; 4) Agree to sign the informed consent form, allowing for the extraction of medical record data (CRF) and participation in questionnaires/ interviews; 5) Interviews are prioritized for patients with a diagnostic delay of > 12 months or an HADS score of >=8, to explore significant psychological burden or barriers to seeking medical treatment.

Exclusion criteria

Exclusion criteria: 1) Unconfirmed CSU, such as only diagnosed as "urticaria" or acute urticaria; 2) Diagnosed as chronic inducible urticaria (CIndU) or other skin diseases (such as urticarial vasculitis, eczema); 3) The medical record lacks the time of symptom onset or diagnosis, making it impossible to calculate the diagnostic delay; 4) Age less than 18 years or more than 80 years, or having severe cognitive impairment, unable to complete the questionnaire/interview; 5) Complicated with severe systemic diseases (such as systemic lupus erythematosus, malignant tumors), which may interfere with the CSU diagnosis or psychological assessment; 6) Refused to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
Time from symptom onset to diagnosis (days);

Secondary

MeasureTime frame
Quality of life score (CU-Q2oL total score); Psychological status score (HADS total score);Symptom severity (UAS7 score);Number of misdiagnoses before correct diagnosis;

Countries

China

Contacts

Public ContactMin Li

General Hospital of Western Theater Command

limin0214@126.com+86 181 1656 4370

Outcome results

None listed

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