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:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT05455060
Eligibility Criteria:
Inclusion Criteria:
1. All volunteers must sign an informed consent form.
2. Male and female patients aged 6 to 60 years.
3. Patients who are diagnosed with AD by expert clinicians at Taoyuan, Linkou or Taipei Chang Gung Memorial Hospital and Taipei Veterans General Hospital in Taiwan and met the criteria of Hanifin and Rajka diagnostic criteria will be considered for enrollment in this study.
4. SCORing Atopic Dermatitis (SCORAD) score ≧ 25
Exclusion Criteria:
1. Other skin diseases that are not AD, such as contact dermatitis, seborrheic dermatitis, or drug-induced dermatitis, which will be diagnosed by expert clinicians
2. Patients with other itching skin diseases at the same time, diagnosed by expert clinicians
3. Patients who have secondary bacterial infections or receiving oral or intravenous steroid treatment, antibiotics, leukotriene modifiers, phototherapy or other immunosuppressive therapies in the previous 1 month
4. Patients who cannot take the medicine regularly, or who can not cooperate in writing the questionnaires or taking blood tests
5. Allergy to Chinese medicine or use of other Chinese medicine treatments
6. Severe organ dysfunction, such as impaired renal and hepatic function at initial diagnosis (including chronic kidney disease stages III, IV, and V and AST, ALT ≥3 × the upper normal limit), liver cirrhosis, or heart failure
7. Uncontrolled psychiatric problems or other severe systemic diseases
8. Current pregnant or breast-feeding women, and all women of childbearing age must agree to take appropriate contraceptive precautions
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
60 Years
Study:
NCT05455060
Study Brief:
Protocol Section:
NCT05455060