Evaluating Shuiniujiao Dihuang Decoction Compared to Placebo for Adults with Mild to Moderate Plaque Psoriasis Aged 18 to 75

What this Trial Is About

Psoriasis vulgaris is an inflammatory skin disease that significantly affects patients quality of life, with a prevalence of 2% to 3% in the general population. The most common form, plaque psoriasis, appears as red, well-defined, silvery plaques mainly on the umbilical and lumbosacral areas, elbows, knees, and scalp. Current treatments include retinoids, corticosteroids, vitamin D analogs, and biologics, but side effects and high costs limit access for many patients. This research evaluates the traditional Chinese medicine formula Shuiniujiao Dihuang Decoction with Variation SDD as a potential treatment for mild to moderate plaque psoriasis. Participants in this randomized, double-blind, placebo-controlled trial will be assigned to receive either SDD formula granules or placebo granules, both taken twice daily at 37 grams per dose, for 12 weeks. The SDD formula includes 23 herbal medicines selected for their properties to eliminate pathogenic heat, expel blood stasis and dampness, nourish yin, and reduce itching. The study aims to provide clinical evidence to support the development of SDD as an anti-psoriatic agent. During the study, participants will undergo assessments including the Psoriasis Area and Severity Index PASI and Static Physician Global Assessment sPGA at week 12 as primary outcomes. Secondary measurements will include symptom patterns, body surface area affected, quality of life questionnaires, itch scales, serum inflammatory markers, microbiota composition, and gene expression at various timepoints up to week 18. Safety will be monitored through adverse event tracking and laboratory tests. The total study duration for participants is 18 weeks, including follow-up after treatment completion.

Shuiniujiao Dihuang Decoction With Variation for the Treatment of Psoriasis