Psoriasis
Conditions
Interventions
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The age is 18-70 years old, both male and female; 2. The patients who meet the diagnostic criteria of psoriasis and the syndrome differentiation criteria of blood stasis syndrome of traditional Chinese medicine at the same time; 3. Patients with moderate to severe illness (BSA >= 3 or PASI >= 3); 4. Patients with informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women, or those who plan pregnancy during the study period; 2. Patients with SAS score > 50 or SDS standard score > 53, or with other mental disorders; 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 > 1.5 times the upper limit of normal value; creatinine is higher than 1.5 times of the upper limit of normal value; liver fibrosis (p3np) > 2 times of the upper limit of normal value; HIV serological test is positive; any of the main blood routine indicators is lower than the lower limit of normal value; or other abnormal laboratory tests are judged by researchers Patients who are not suitable for this trial; 4. Patients who are known to be allergic to the drugs used in this study and those with related drug ingredients; 5. Patients with head and face lesions; 6. Those who are participating in other drug clinical trials or have participated in other clinical trials within 12 weeks; 7. Those who used traditional Chinese medicine or Chinese herbal products or topical therapy (antibiotics, external corticosteroids, vitamin D3 analogues, calcineurin inhibitors, keratolytics, et al) within 2 weeks; those who had used oral systemic therapies (methotrexate, ciclosporin A, acitretin, fumarates, et al) or ultraviolet treatment within 4 weeks; those who had received biological agents within 5 half-life periods (17.5 days of Etanercept, 50 days of Infliximab, 70 days of Adalimumab, 105 days of Ustekinumab, 135 days of Secukinumab, et al); 8. The cumulative dose of MTX used in the past was more than 1.5g; 9. Patients considered unsuitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients who achieve at least 75% improvement in PASI score from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| The improvement in PASI score from baseline after treatment;The proportion of patients who achieve at least 90% improvement in PASI score from baseline;The proportion of patients who achieve at least 50% improvement in PASI score from baseline;Main symptoms of psoriasis scale score;Physician's global assessment (PGA) score;Pruritus Scores on the Visual Analogue Scale score;Dermatology Life Quality Index (DLQI);Skindex16;Therapy compliance;Relapse rate;Rebound rate;Patients' attitudes, expectation and experience; | — |
Countries
China
Contacts
Public ContactChuanjian Lu
Guangdong Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed