Chronic Spontaneous Urticaria
Conditions
Interventions
Desloratadine Citrate Disodium Capsules 17.6 mg group:Take 17.6 mg Desloratadine Citrate Disodium Capsules
Desloratadine Citrate Disodium Capsules 26.4 mg group:Take 26.4 mg Desloratadine Citrate Disodium Capsules
Desloratadine Citrate Disodium Capsules 35.2 mg group:Take 35.2 mg Desloratadine Citrate Disodium Capsules
Sponsors
The Third People's Hospital of Bengbu
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 65, male or female is acceptable; 2.Meeting the diagnostic criteria for Chronic Spontaneous Urticaria outlined in the 'Chinese Guidelines for Diagnosis and Treatment of Urticaria', with no clear precipitating factors, hives occurring daily or intermittently, and a disease duration exceeding 6 weeks; 3.Patients who have taken standard doses of antihistamines for 2 weeks or longer prior to screening and have shown ineffective treatment outcomes; 4.Within 7 days prior to dosing (Day 1), patients must have a Urticaria Activity Score over the last 7 days (UAS7) >= 16, an Itch Severity Score over the last 7 days (ISS7) >= 8, and an Urticaria Activity Score (UAS) at the screening visit or on the day of dosing (Day 1) >= 4 at the outpatient clinic; 5.Individuals who are willing and able to complete daily symptom diary records during the study period; 6.Prior to the start of the trial, participants must voluntarily sign an informed consent form approved by the ethics committee;
Exclusion criteria
Exclusion criteria: 1.Physical urticaria, cholinergic urticaria, and urticaria caused by other clear reasons, etc; 2.Other diseases accompanied by symptoms of urticaria or angioedema, including but not limited to urticarial vasculitis, urticarial pigmentosa, polymorphic erythema, mastocytosis, hereditary urticaria, or drug-induced urticaria; 3.Any other skin diseases accompanied by chronic pruritus that the investigator believes may affect the assessment and outcome of the study, such as atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, pruritus senilis, or psoriasis; 4.Subjects with clinically significant severe diseases of the liver, kidney, cardiovascular system, respiratory system, endocrine system, hematology, urinary system, metabolic system, or central nervous system, and whom the investigator believes may compromise the safety of the subject, interfere with the interpretation of study results, or otherwise hinder the subject's participation or adherence to the protocol; 5.A history of allergy to the study drug, its excipients, or drugs of similar chemical classes; 6.Individuals with hepatic or renal dysfunction (ALT or AST levels greater than 2 times the upper limit of normal, or creatinine levels greater than 1.5 times the upper limit of normal); 7.Subjects who have received a live, attenuated vaccine within 6 weeks prior to dosing, or who are required to receive a vaccination at any time during the study drug treatment period; 8.Subjects who have participated in and received other drug or device clinical trials within 3 months prior to screening; 9.Pregnant women, lactating women, or patients planning pregnancy; 10.Patients whom the investigator deems unsuitable for participation in this clinical study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with completely controlled symptoms during the treatment period;Proportion of recurrent subjects during maintenance treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in UAS7 levels of each dose group compared to baseline at the end of the treatment period;Changes in ISS7 levels of each dose group compared to baseline at the end of the treatment period;The proportion of patients with UAS7<7 in each dose group at the end of the treatment period;Incidence of adverse events (AE) in each group;Occurrence of serious adverse events (SAEs) in each group; | — |
Countries
China
Contacts
Public ContactYang Meng
The Third People's Hospital of Bengbu
Outcome results
None listed