Psoriasis
Conditions
Interventions
Sponsors
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnostic criteria of western medicine for plaque psoriasis and the diagnostic criteria of TCM syndromes of blood heat syndrome; 2) PGA >= 3, PASI >= 12, and BSA >= 10% at screening and baseline; 3) Aged 18 and 65 years; 4) Consent to participate in the research study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Patients with pustular psoriasis,arthrotype, erythroderma psoriasis and / or drip psoriasis; 2) Any clinically active skin diseases other than moderate to severe psoriasis vulgaris which might counter or influence the study aim; 3) Patients who used any of the following systemic treatments within 4 weeks before the Baseline visit eg: drugs for other studys, immuno-suppressive drugs, biologics; 4) Patients who used topical treatment within 2 weeks before the Baseline visit eg corticosteroids ultraviolet-light therapy including sunbathing; 5) Active infectious disease which was hard to control; 6) People infected with tuberculosis; 7) Patients with viral hepatitis; 8) History of severe systemic disease. Or the clinical test index is one of the following: the ALT or the AST is higher than 1.5 times the normal value limit; the creatinine(Cr) is higher than 1.5 times the normal value limit; anyone of the main blood indicators (white blood cells count, red blood cells count, hemoglobin, platelet count) is lower than normal lower limit;or patients with other abnormal laboratory tests that the researchers judged unfit to participate in the trial; 9) A history of cancer and patients with primary or secondary immunodeficiency and hypersensitivity; 10) Participate in other clinical trials within 3 months prior to the baseline; 11) Received a major operation within 8 weeks prior to the baseline or study period; 12) Women who have fertility refusal to adopt contraception from the screening period to the last time after the end of the drug delivery; 13) Pregnancy or lactation; 14) Subjects with smokehard-drinkingtake drugs and drug abuse; 15) Subjects with history or family history of severe psychosis; 16) Other subjects judged by the investigator to be ineligible for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recurrence rate;PASI; | — |
Secondary
| Measure | Time frame |
|---|---|
| BSA;VAS;DLQI;TCM syndrome score;PRQoL;Physician's Global Assessment; | — |
Countries
China
Contacts
Public ContactLi Xin
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed