Efficacy and Safety of Jueyin Granules for Patients with Mild-to-Moderate Psoriasis Vulgaris: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial

Ethnopharmacological relevance: Psoriasis is an immune-mediated inflammatory skin disease. By more than a decade of clinical validation, Jueyin granules (JYG) have demonstrated multi-target synergistic immunomodulatory and anti-inflammatory effects, offering a characteristic Traditional Chinese Medicine (TCM) therapeutic approach for psoriasis.Aim of the study: To assess the efficacy and safety of oral JYG in treating psoriasis with blood-heat syndrome.Materials and Methods: Participants with body surface area (BSA) score less than 10 were allocated to receive JYG or placebo treatment in a 1:1 ratio through central area division and block randomization. The primary outcome is reduction of the psoriasis area severity index (PASI) score and proportion of participants achieving a greater than 50% reduction in PASI scores (PASI50) at week 8.Results: Between November 2019 and April 2022, 195 participants were randomly assigned to receive JYG (n = 99) or a placebo (n = 96) at five centers. The JYG group demonstrated significantly greater reductions in PASI and BSA scores than the placebo group at week 8 (both P < 0.001) and maintained these improvements at week 16 (P < 0.001 and P = 0.005, respectively). By week 8, 51.09% of participants in the JYG group achieved PASI50, compared to 20.65% in the placebo group (P < 0.001). However, there were no statistical differences in dermatology life quality index (DLQI) , visual analog scale (VAS) scores, or relapse rate.Conclusions: This study provides conclusive evidence that JYG is a safe and effective treatment for patients with mild-to-moderate psoriasis. The current findings support its use as a complementary and alternative therapy for psoriasis.