Sequential Treatment of Psoriasis With Traditional Chinese and Western Medicine

• Status: Not yet recruiting
• Trial end date: 2024-09-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to objectively and standardly evaluate the clinical efficacy and safety of sequential treatment of psoriasis with traditional Chinese and Western medicine through a multi-center, randomized, double-blind, placebo-controlled trial.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shanghai Yueyang Integrated Medicine Hospital
• Collaborator: Shanghai Skin Disease and Venereal Disease Hospital
• Treatments: Ixekizumab

Criteria

Inclusion Criteria:

1. It conforms to the western diagnostic criteria of plaque psoriasis and the diagnostic criteria of TCM syndrome of blood heat syndrome;

2. Physician global assessment (PGA) ≥3, psoriasis area and severity index (PASI) score ≥12, and body surface area (BSA) ≥ 10% at screening and baseline;

3. Aged between 18 and 70;

4. Those who voluntarily participate in the study and sign the informed consent.

Exclusion Criteria:

1. Erythrodermic psoriasis patients, arthropathic psoriasis patients, pustular psoriasis patients;

2. There are other active skin diseases that may affect the evaluator;

3. Have systematically received other investigational drugs within 1 month;

4. Received external glucocorticoid and phototherapy within 2 weeks;

5. During a period of severe and uncontrollable local or systemic acute or chronic infection;

6. Infected persons with tuberculosis;

7. Patients with viral hepatitis;

8. Serious systemic disease; Or clinical test indicators belong to one of the following cases of patients: alanine aminotransferase or glutamic-oxalacetic transaminase increase > 1.5 times the upper limit of normal value; Creatinine increase > 1.5 times the upper limit of normal value; Any one of the major blood routine indicators (white blood cell count, red blood cell count, hemoglobin amount, platelet count) is lower than the lower limit of normal value; Or other abnormal laboratory tests determined by the investigator to be unsuitable for the study;

9. Patients with a history of malignant tumor and patients with primary or secondary immune deficiency and hypersensitivity;

10. Participants in clinical trials of other drugs within 3 months;

11. Those who have undergone major surgery within 8 weeks or will require such surgery during the study period;

12. For fertile women of childbearing age who did not use highly effective contraception from the screening period until the end of the last dose;

13. Pregnant or lactating women;

14. Persons with a history of alcohol, drug or substance abuse;

15. Persons with a serious history of mental illness or family history;

16. For other reasons, the researcher considers it inappropriate to participate in this study.