Psoriasis
Conditions
Interventions
Compound Qingdai Capsules with Fish Oil Treatment Group:Compound Qingdai Capsules, 3 times daily, 4 capsules each time
combined with Fish Oil, 2 times daily, 1 capsule each time
Compound Qingdai Capsules Placebo Control Group:Compound Qingdai Capsules, 3 times daily, 4 capsules each time
combined with Corn Oil Placebo (identical packaging, formulation, and odor to fish oil)
Sponsors
Gong An County People's Hospital, Hubei Province
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-70 years old (inclusive of boundary values), no gender restriction; 2. Clinically diagnosed with moderate to severe plaque psoriasis, as defined by the severity classification in the "Chinese Guidelines for the Diagnosis and Treatment of Psoriasis (2023 Edition)": PASI = 3, BSA = 3% or DLQI = 6; 3. No important active infections clinically; 4. No systemic treatment within the past 2 months; 5. Willing to adhere to regular medication as prescribed by a doctor for at least 12 weeks and accept regular follow-ups, with complete clinical baseline data, visit records, and medical history.
Exclusion criteria
Exclusion criteria: 1. Individuals with active tuberculosis, active hepatitis B virus infection, human immunodeficiency virus (HIV) infection, severe bacterial infections, or other severely immunocompromised individuals; those with severe diseases of vital organs and tissues (e.g., heart, brain, lung, liver, kidney), severe liver or kidney dysfunction, or malignant tumors; 2. Female patients who are pregnant, lactating, or planning to become pregnant in the near future; 3. Individuals with a history of allergy or intolerance to Compound Qingdai Capsules or fish oil; 4. Other conditions that the investigator deems unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Psoriasis Area and Severity Index (PASI) score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in body surface area (BSA) affected by psoriasis;Change from baseline in Physician Global Assessment (PGA);Change from baseline in Dermatology Life Quality Index (DLQI);Improvement in scalp psoriasis severity index (PSSI) score from baseline;Improvement in modified Nail Psoriasis Severity Index (mNAPSI) score from baseline;Improvement in static physician global assessment for genital psoriasis (sPGA-G) score from baseline;Fasting blood glucose;Lipid panel (7 items);Hemoglobin A1c (HbA1c);Inflammatory markers (including IL-6, IL-17A, IL-23, IL-1ß, IL-22, IL-10, TNF-a, IFN-?, CCL20, hs-CRP);Immune markers (including nerve growth factor [NGF], transforming growth factor-beta 1 [TGF-ß1], vascular endothelial growth factor [VEGF], vascular endothelial growth factor receptor-1 [VEGFR-1], vascular endothelial growth factor receptor-2 [VEGFR-2], monocyte chemoattractant protein-1 [MCP-1]);Serum metabolite profile (amino acids, lipids, nucleotides, organic acids, vitamins, etc.); | — |
Countries
China
Contacts
Public ContactChen Jinfang
Gong 'an County People's Hospital
Outcome results
None listed