Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2025-12-24 @ 3:49 PM
NCT ID:
NCT04967092
Eligibility Criteria:
Inclusion Criteria:
1. Both male and female;
2. Age from 18 to 65 years;
3. Documented history of CU for at least 6 weeks prior to entry in the study;
4. Meet EAACI/GA2LEN/EDF/WAO 2017 guidelines, i.e. spontaneous appearance of wheals, angioedema or both for \> 6 weeks due to known or unknown causes;
5. Symptom severity must be greater than 10 points (UAS7 score);
6. Able to complete questionnaires and take medications as scheduled; and
7. Agree to participate in the study and sign the informed consent.
Exclusion Criteria:
1. Dual deficiency of Qi and blood according to Chinese medicine theory
2. Urticaria is induced by physical factors (e.g., cold urticaria, delayed pressure urticaria, solar urticaria, heat urticaria, vibratory angioedema) only;
3. Known to have dermatological diseases with skin pruritus;
4. Known to have any serious diseases such as cancer, severe kidney and liver impairments, autoimmune disease, thyroid disease, Hodgkin's disease, lymphoma, severe mental disorders, leukemia, and acute infectious disease;
5. Known to use oral/injectable corticosteroids, leukotriene inhibitors, immunosuppressants or other Chinese herbal medicine within one month of enrollment;
6. Known to receive omalizumab, ligelizumab, or other experimental biologic for CU;
7. Documented pregnancy or planning to conceive, breast-feeding women; or
8. Operate heavy machinery or need to drive motor vehicles as an essential part of their profession.
9. Know recent history (within previous 12 months) of drug addiction or alcohol abuse.
10. Involved in other interventional clinical studies at the same time.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04967092
Study Brief:
Protocol Section:
NCT04967092