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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT06402760
Eligibility Criteria:
Inclusion Criteria:
1. Meet the Western medicine diagnostic criteria for vulgaris psoriasis and the Traditional Chinese Medicine diagnostic criteria for blood stasis syndrome in psoriasis.
2. Newly diagnosed or previously diagnosed with psoriasis; if previously diagnosed, prior treatment methods are not restricted.
3. Identified as high risk for comorbid diabetes based on a risk model calculation.
4. Age between 18 and 80 years old, any gender.
5. Willing to participate in this study and provide informed consent.
Exclusion Criteria:
1. Patients already diagnosed with diabetes.
2. Presence of other active skin diseases that may affect the assessment of the condition.
3. In severe, difficult-to-control acute or chronic infection locally or systemically.
4. Severe systemic diseases; or patients with clinical laboratory indicators falling into any of the following conditions:
① Hematology: Hemoglobin (HGB) \< 90g/L; Platelet count (PLT) \< 10010\^9/L; White blood cell count (WBC) \< 310\^9/L; Absolute neutrophil count (NEUT) \< 1.5\*10\^9/L;
② Liver function: Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) exceeding 3 times the upper limit of normal (ULN) or total bilirubin exceeding 1.5 times the upper limit of normal;
③ Renal function: Serum creatinine greater than 1.5 times the upper limit of normal;
④ Other abnormal laboratory test results judged by the investigator to potentially affect the patient's completion of the trial or interfere with the trial results.
5. History of malignant tumors and primary or secondary immunodeficiency or hypersensitivity.
6. Underwent major surgery within 8 weeks or will require such surgery during the study period.
7. Pregnant or lactating women.
8. History of alcoholism, drug abuse, or substance abuse.
9. History of severe mental illness or family history thereof.
10. Family history of tumors.
11. Other reasons deemed inappropriate for participation by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06402760
Study Brief:
Protocol Section:
NCT06402760