Protocol for a cohort study of comprehensive intervention of psoriasis and diabetes comorbidity prevention and control using traditional Chinese medicine of blood-activating and stasis-dissolving method

Abstract

Psoriasis is a chronic systemic inflammatory disease associated with an increased risk of metabolic dysfunction, including type 2 diabetes mellitus (T2DM). Insulin resistance and chronic inflammation may contribute to this association. Blood-activating and stasis-dissolving therapies in traditional Chinese medicine (TCM) have shown potential anti-inflammatory and metabolic benefits. This study aimed to evaluate an integrated TCM-based intervention in patients with psoriasis at high risk of T2DM. Participants aged 18–80 who met predefined diagnostic criteria for psoriasis vulgaris and blood-stasis syndrome will be recruited. Individuals identified as being at high risk for T2DM using a validated multifactorial diagnostic model will be allocated to two groups according to clinical assessment and treatment preference. The conventional strategy group (CSG) will receive guideline-based conventional psoriasis treatment, while the integrated strategy group (ISG) will receive standard care combined with Taodan granules (TDG), fish oil supplementation, and a structured aerobic exercise programme. The primary analysis will employ linear mixed-effects models with a difference-in-differences approach to compare changes in outcomes between groups. Propensity score matching will be performed as a sensitivity analysis to balance baseline characteristics. The primary outcome is the change in insulin resistance from baseline to Week 16, assessed using the homeostasis model assessment of insulin resistance (HOMA-IR). Key secondary outcomes include changes in psoriasis severity assessed by the psoriasis area and severity index (PASI), including PASI 50, PASI 75, and PASI 90 response rates. Exploratory outcomes include the incidence of new-onset T2DM and changes in circulating inflammatory biomarkers, including IL-1β, IL-6, TNF-α, IL-17A, and FGL1, to explore potential mechanisms underlying the effects of the integrated intervention. This study aims to evaluate the effects of an integrated TCM-based intervention on dermatological and metabolic outcomes in patients with psoriasis at high risk of T2DM. The findings may provide clinical evidence to support policymakers in developing management strategies for psoriasis and related metabolic comorbidities. This trial was registered at ClinicalTrials.gov (ID: NCT06402760).