Predicting comorbidities in psoriasis using TCM constitution and multimodal data: a prospective cohort study protocol

Psoriasis is a chronic inflammatory skin disease associated with multiple systemic comorbidities. Patients exhibit considerable individual variability in response to systemic therapies, making treatment outcomes and adverse reactions difficult to predict. Traditional Chinese Medicine (TCM) constitution theory may explain this variability, but prospective validation is lacking. This study primarily aims to evaluate the predictive value of TCM constitution types and multimodal clinical data for comorbidity risk in patients with psoriasis. As a secondary objective, it will also explore the association between TCM constitution and systemic treatment effectiveness and adverse events.

This is a multicenter, prospective, observational cohort enrolling 1000 adults (≥18 years) with psoriasis who are scheduled to initiate systemic therapy. Over a 52-week period, we will collect comprehensive data on TCM constitution types, syndrome patterns, and multimodal clinical data. All participants will be followed to monitor comorbidity progression and, secondarily, to assess the effectiveness of systemic therapies and record adverse events.

By leveraging a digitized platform for TCM and clinical data collection, this prospective study aims to validate the relationship between TCM constitution types and psoriasis comorbidities and, secondarily, treatment responses. The ultimate objective is to build integrated predictive models for comorbidity risk as the primary outcome and treatment outcomes as secondary endpoints, combining TCM-based features with modern clinical indicators to advance personalized medicine in psoriasis.

The study protocol was approved by the Medical Ethics Review Committee of The Second Affiliated Hospital of Hunan University (ID: 2025-KY-036-01) and the Medical Ethics Review Committee of Xiangya Hospital, Central South University (ID: 2025122317). Study results will be published in peer-reviewed journals and presented at national and international conferences. In addition, lay summaries of the findings will be made available to participants and the public via the hospitals' websites and other public forums.

https://www.chictr.org.cn/searchprojEN.html, identifier [ITMCTR2025002518].