Chronic spontaneous urticaria
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years, no gender limit; 2. Comply with the diagnostic criteria for chronic spontaneous urticaria in the ''Guidelines for Diagnosis and Treatment of Urticaria'', the course of the disease lasts more than 6 weeks, visible urticaria lesions occur at least 3 days a week, and the conventional dose of antihistamines has not been effective in the past. Good medical history; 3. The severity of the disease is moderate to severe, that is, UAS7>=16 points, ISS7>=8 points; and during this period at least 3 days, there are two index scores of pruritus score, wind mass score, and maximum wind mass diameter score >=2 points; 4. Those who are willing and able to complete the daily symptom diary record during the research period; 5. Before the start of the trial, the patient or his legal representative voluntarily signed an informed consent form approved by the ethics committee.
Exclusion criteria
Exclusion criteria: 1. Patients with concomitant diseases or medications (such as corticosteroids, H2 antagonists, non-steroidal anti-inflammatory drugs, anti-leukotriene drugs, anti-sympathetic or central nervous system sedative drugs) that may interfere with their CSU symptoms or increase the risk of adverse reactions; 2. Cholinergic urticaria and other urticaria with clear causes, etc.; 3. Known history of allergy to this drug component; 4. Patients with liver and kidney dysfunction (ALT or AST greater than 2 times the upper limit of normal, creatinine value greater than 1.5 times the upper limit of normal) and autoimmune diseases; 5. Pregnant, lactating patients or patients planning pregnancy; 6. Abnormal ECG parameters (PR, QRS, QT and QTc intervals) have clinical significance (subject to the clinician's judgment); 7. Participated in or is participating in other clinical studies within 1 month prior to the date of obtaining informed consent; 8. Patients considered unsuitable for this clinical study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| weekly urticaria activity scores;weekly itch-severity scores; | — |
Secondary
| Measure | Time frame |
|---|---|
| visual analogue scale; | — |
Countries
China