Moderate to severe plaque psoriasis
Conditions
Interventions
Experimental group:Kunxian Capsule ( 0.3g per capsule): 2 capsules per dose, t.i.d, taken with meal, treated for 12 weeks
Methotrexate tablets placebo(2.5mg per tablet): 3 tablets a week.
Control group:Kunxian Capsule placebo: 2 capsule per dose, t.i.d, taken with meal, treated for 12 weeks
Methotrexate tablets(2.5mg per tablet): 3 tablets a week.
Sponsors
Shanghai Tenth People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18-65, unlimited gender. 2. Patient diagnosed as moderate or severe plaque psoriasis more than 6 months before screening,with or without psoriatic arthritis. 3. Body surface area affected by psoriasis>=10% 4. Psoriasis lesion area and severity index(PASI) score>=10. 5. Patients(male or female) agree to take effective contraceptive measures during the study and within 6 months after the last dose. 6. Voluntarily participate in the study and provided signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. Used anti-psoriatic topical drugs within 2 weeks before enrollment. 2. Used systemic treatment or phototherapy within 4 weeks before enrollment. 3. Allergic to any ingredient of Tripterygium Wilfordii, Kunxian capsule and methotrexate. 4. History of tuberculosis or currently have active tuberculosis. 5. Have peptic ulcer or ulcerative colitis. 6. History of serious heart disease such as congestive heart failure and myocardial infarction occurred within 12 weeks before screening. 7. History of surgery within 8 weeks before screening or scheduled surgery during the study. 8. Concomitant with other serious diseases, including but not limited to disorders of cardiovascular system, nervous system,urinary system, blood system disease or malignant tumor. 9. Any anormality of laboratory tests in screening: - White blood cell count 2xULN - Platelets 1.5 x ULN 10. Currently have active infection or required systemic anti-infective treatment within 4 weeks before screening, or hospitalization due to serious infection and received intravenous anti-infective treatment. 11. Lactating or pregnant women. 12. History of alcohol abuse or drug abuse. 13. History of psychotic disorders. 14. Participated in other clinical study within 3 months before enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who achieved psoriatic lesion area and severity index (PASI) scores decreased by >=75% from baseline.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients who achieved complete clearance (0 point) or very mild (1 point) based on physician global assessment (PGA);Proportion of patients who achieved psoriatic lesion area and severity index (PASI) scores decreased by >= 90% from baseline.;Proportion of patients who achieved psoriatic lesion area and severity index (PASI) scores decreased by >= 50% from baseline.;Average change of baseline-adjusted PASI score;Average change of baseline-adjusted PGA score;Average change of baseline-adjusted Dermatology Life Quality Index (DLQI) score;Proportion of patients who achieved PGA scores decreased by >= 2 from baseline.;Average change of baseline-adjusted CRP and ESR level; | — |
Countries
China
Contacts
Public ContactShi Yuling
Shanghai Tenth People's Hospital
Outcome results
None listed