psoriasis vulgaris
Conditions
Interventions
experimental group:LbGp combined with the Guben QuShi HuaYu Formula
control group:LbGp placebo combined with the Guben QuShi HuaYu Formula
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients meeting diagnostic criteria for plaque psoriasis. 2. Disease severity meeting mild-to-moderate classification at enrollment: Psoriasis Area and Severity Index (PASI) 8 but < 35 Absence of significant suicide risk (Item 3 score = 1) Exclusion of major depressive disorder (MDD) per DSM-5 criteria. 4. Aged 18–65 years inclusive; both sexes eligible. 5. Provision of written informed consent and willingness to comply with scheduled follow-ups.
Exclusion criteria
Exclusion criteria: 1. Pregnancy lactation or planned pregnancy during the study period; 2. inverse psoriasis psoriatic arthritis pustular psoriasis or erythrodermic psoriasis; 3. Known or suspected uncontrolled/severe systemic comorbidities: cardiovascular respiratory hematologic or malignant disorders; severe anemia; hyperthyroidism/hypothyroidism; 4. History of severe psychiatric disorders organic mental disorders cerebral organic diseases or traumatic brain surgery; 5. Major depressive disorder (MDD) diagnosis within 6 months pre-enrollment or suicidal ideation/behavior within 6 months; 6. Current DSM-5-defined diagnoses: major depressive disorder generalized anxiety disorder bipolar disorder etc.; 7. Major stressful life events within the past month (e.g. bereavement financial collapse natural disasters severe physical illness disability); 8. Known hypersensitivity to investigational agents (Guben QuShi HuaYu Formula LBGp) or their components; 9. Concurrent participation in other drug trials or trial participation within 4 weeks; 10. Recent therapies: Topical agents (antibiotics corticosteroids vitamin D3 analogs calcineurin inhibitors keratolytics) within 2 weeks; Systemic therapies (methotrexate acitretin cyclosporine fumaric acid esters) or phototherapy within 4 weeks; Biologics within 5 half-lives prior to enrollment (e.g. etanercept: 17.5 days; infliximab: 50 days; adalimumab: 70 days; ustekinumab: 105 days; secukinumab: 135 days; ixekizumab: 65 days); 11. Antidepressant use within 1 month pre-enrollment; 12. Severe aphasia agnosia intellectual disability or inability to complete assessments; 13. Regular consumption of Lycium barbarum-containing herbal products within 3 months pre-enrollment; 14. Chronic corticosteroid or endocrine medication use; 15. Non-compliance with follow-up requirements; 16. Other conditions deemed by investigators to be unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean difference in HAMD-24 score changes.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The average difference in GAD-7 scores before and after treatment.;The average difference in BSA scores before and after treatment.;The average difference in PGA scores before and after treatment.;Reduction rate of HAMD-24;The improvement in PASI score from baseline after treatment.;The changes in the internal factors of the HAMD-24.;The average difference in VAS scores before and after treatment.;Mean difference in PHQ-9 score changes.;The average difference in PSQI scores before and after treatment.;The remission rates of HAMD-24.;The average difference in DLQI scores before and after treatment.;Incidence rate of adverse reactions.; | — |
Countries
China
Contacts
Public ContactChuanjian Lu
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed