chronic spontaneous urticaria
Conditions
Interventions
control group:Omalizumab and second-generation H1-AH antihistamines
intervention group:Shenqi Formula combined with Omalizumab and second-generation H1-AH antihistamines
Sponsors
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Meet the clinical diagnostic criteria for CSU and qi and blood deficiency syndrome for yinzhen in traditional Chinese medicine;(2) Aged between 18 and 65 years with no gender restrictions;(3) Volunteer to participate in this study and signed the informed consent form;(4) Treatment with OMA currently
Exclusion criteria
Exclusion criteria: (1) Presence of other skin diseases or active conditions that may affect the evaluation of efficacy such as angioedema or lupus erythematosus.(2)Severe mental illness cognitive impairment lacking personal autonomy or unsuitable for clinical research participation.(3) Currently experiencing severe uncontrollable acute or chronic infections.(4) Presence of severe systemic diseases or clinical test results meeting any of the following conditions: (a) Alanine aminotransferase or aspartate aminotransferase levels elevated by more than 1.5 times the normal value; (b) Serum creatinine levels elevated by more than 1.5 times the upper limit of the normal value; (c) Any of the major blood routine parameters (white blood cell count red blood cell count hemoglobin level platelet count) below the lower limit of the normal range; (d) Other laboratory test abnormalities in which the investigator deems the patient unsuitable for participation in the study.(5) History of malignant tumors primary or secondary immune deficiencies and hypersensitivity patients.(6) Underwent major surgery within the past eight weeks or being expected to undergo such surgery during the study period.(7) Pregnant or breastfeeding women. (8) A history of alcohol abuse drug addiction or substance abuse. (9) Individuals with a history of severe psychiatric disorders or a family history thereof; (10) Contraindications for the use of omalizumab. (11) Other reasons that may making the patient unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 7-day Urticaria Activity Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine syndrome score;chronic urticaria quality of life questionnaire;Urticaria control test;total serum IgE levels; | — |
Countries
China
Contacts
Public ContactLi Xin
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of Traditional Chinese Medicine
Outcome results
None listed