psoriasis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age from 18-70 years 2. Psoriasis Area and Severity Index (PASI) score=10 or Body Surface Area (BSA) =10 3. Meet the requirement of using secukinumab; without the history of inflammatory bowel disease (IBD) 4. Written/signed informed consent
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women, or those who plan pregnancy during the study period. 2. Patients with inflammatory bowel disease (IBD) 3. Patients with severe primary diseases such as respiratory system and circulatory system that cannot be controlled by conventional medication; patients with severe infection, tuberculosis, hepatitis and other infectious history, lymphocyte proliferation, hematopoietic system abnormalities, tumor; patients with severe water, electrolyte and acid-base balance disorder; patients with primary or secondary immune deficiency and hypersensitivity. Or clinical test indicators are one of the following cases: alanine aminotransferase or glutamic oxaloacetic transaminase increase more than 3 times the upper limit of normal value; creatinine is higher than 1.5 times of the upper limit of normal value; creatinine more than 1.5 times of the upper limit of normal value; serological test of human immunodeficiency virus (HIV) is positive; Any main indicators of blood test is below the lower limit of normal; or patients are assessed as unsuitable for this trial by researchers through other abnormal laboratory tests. 4. Patients who are known to be allergic to the medication and its related ingredients used in this study and those with related medication ingredients. 5. Those who are participating in other medication clinical trials or have participated in other clinical trials within 4 weeks. 6. Those who used traditional Chinese medicine or Chinese Medicine products or external antibiotics within 2 weeks; those who used hormonal and other external medication or phototherapy within 4 weeks; those who had received methotrexate, cyclosporin A or oral antibiotics within 12 weeks; those who had received acitretin or biological agents within 24 weeks. 7. Patients are assessed as unsuitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the rate of relapse; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to relapse;The proportion of patients who achieve at least 75% improvement in PASI score from baseline;The proportion of patients who achieve at least 90% improvement in PASI score from baseline;The improvement in PASI score from baseline after treatment;Physician's global assessment (PGA) score;Pruritus Scores on the Visual Analogue Scale score;Dermatology Life Quality Index (DLQI);Patients' attitudes, expectation and experience;Skindex16; | — |
Countries
China
Contacts
Guangdong Provincial Hospital of Chinese Medicine