Exploratory clinical trial to evaluate the efficacy of a topical traditional chinese herbal medicine in psoriasis vulgaris.

Objective. To evaluate the efficacy and safety of herbal ointment, Shi Du Ruan Gao, in patients with plaque-type psoriasis. Design. Single-center, randomized, investigator-blinded, parallel group, placebo-controlled study. Participants. One hundred outpatients with mild to moderate chronic plaque-type psoriasis were enrolled. Intervention. The patients applied either Shi Du Ruan Gao ointment or vehicle ointment topically to for 8 weeks. Main Outcome Measures. The outcomes were assessed using the following criteria: Total Severity Score (TSS, sum of erythema, scaling, and plaque elevation/induration, on a 0 to 4 scale), Investigator Global Assessment (IGA) evaluated on a 0 (Clear) to 4 (s to very severe) scale, and Global Subjects' Assessment of treatment response on a 7-point scale from -1 (worse) to 5 (Cleared). Results. Significant reductions in the Total Severity Score (P < 0.001) (mean score: 2.7 after Shi Du Ruan Gao treatment versus 5.1 in control subjects). Both Investigator Global Assessment (IGA) and Global Subjects' Assessment of treatment are better in the Shi Du Ruan Gao group than the control group (P < 0.001). Conclusion. Shi Du Ruan Gao ointment was a safe, and effective therapy for plaque-type psoriasis.