psoriasis
Conditions
Interventions
Control group:Placebo
Treatment group:Chitosan Nano Qin Teng Blood-Activating and Skin-Moisturizing Cream for External Use
Sponsors
Beijing Traditional Chinese Medicine Hospital affiliated with Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1:Diagnostic criteria for conventional plaque-type psoriasis in Western medicine 2: Psoriasis (Bai Bi) with Blood Stasis Syndrome 3: Age between 18 and 65 years old, no gender restrictions 4: Patients in remission 5: Severity of the condition: mild to moderate skin lesions with PASI between 3 and 10, and BSA between 3 and 10 6: Able to understand the research content, willing to participate as a volunteer, and voluntarily sign the informed consent form. The informed consent process complies with GCP regulations.
Exclusion criteria
Exclusion criteria: 1: Psoriasis induced by drug factors; coexisting non-plaque psoriasis (i.e., guttate, arthropathic, pustular, erythrodermic, or other types of psoriasis); patients whose lesions are present only on special sites such as the face, scalp, nails, folds, glans, mucosa, palms, and soles. 2: Non-biologic treatments with systemic medication received within the first 4 weeks randomly, including but not limited to systemic corticosteroids, retinoids, methotrexate, and cyclosporine. 3: Biologic drug treatment within the first 12 weeks or 5 half-lives of systemic drug therapy (whichever is longer), including but not limited to interleukin antibodies (such as ustekinumab, secukinumab, etc.) and tumor necrosis factor-alpha antagonists (such as etanercept, infliximab, adalimumab, etc.) 4: Received local topical psoriasis treatment within the previous 2 weeks, including retinoids, vitamin D3 derivatives, and glucocorticoids. 5: Physical therapy treatments used within the previous 4 weeks at random, including phototherapy (such as UVB, PUVA), combination phototherapy, balneotherapy, etc. 6: Received systemic anti-infective treatment within the 4 weeks prior to randomization; had recurrent, chronic, or active infections at baseline that the investigator deemed would increase the risk to the participant. 7: Accompanied by severe, progressive, or uncontrolled diseases, including but not limited to a history or current presence of other autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, etc.) or diseases of the endocrine system, hematologic system, urinary system, hepatobiliary system, respiratory system, nervous system, psychiatric system, cardiovascular system, gastrointestinal system, or infectious diseases, malignant tumors; history of drug abuse, alcohol/drug misuse. 8: Patients with blood creatinine levels above the upper limit of normal, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels =1.5 times the upper limit of normal. 9: Patients who have participated in a clinical trial and used the investigational drug within the past month 10: Patients who are allergic to known components of the experimental intervention 11:Patients (including their partners) who plan to conceive, are unwilling to use effective contraception, or are pregnant or lactating during the period from 2 weeks before the first dose until 1 month after the last dose. 12: There are other situations deemed unsuitable for participation in the study, such as subjects having other skin conditions that interfere with psoriasis assessment, potential compliance issues, inability to complete all examinations and evaluations as required by the protocol, or uncontrollable risks associated with participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target Psoriasis Area and Severity Index (tPASI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Target lesion area;Psoriasis Static Physician Global Assessment (sPGA);Itch Numeric Rating Scale (NRS) score;Morphology and number of vascular globules under dermoscopy;The TCM Major Clinical Syndrome Score; | — |
Countries
china
Contacts
Public ContactSunliyun
Beijing Traditional Chinese Medicine Hospital affiliated with Capital Medical University
Outcome results
None listed