Efficacy and Safety of HuaShiXiaoYin Decoction Combined With Secukinumab In Moderate To Severe Plaque Psoriasis: A Study Protocol For a Randomised Controlled Trial (Preprint)

BACKGROUND Psoriasis is a chronic, relapsing inflammatory disease, with plaque psoriasis being the most common subtype and significantly impairing patients’ quality of life. The advent of biologic therapies has greatly improved treatment outcomes; however, relapse after drug discontinuation remains a major challenge. Preliminary clinical observations suggest that Huashixiaoyin Decoction(HSXYD) may reduce the recurrence rate of plaque psoriasis, although its efficacy has yet to be validated in randomized controlled trials. OBJECTIVE This study aims to evaluate the efficacy and safety of HSXYD in combination with Secukinumab for the treatment of moderate-to-severe plaque psoriasis, and to explore its potential in preventing relapse. METHODS This prospective, multicentre, single-blind randomized controlled trial adopts a two-arm, parallel-group design. A total of 128 eligible participants will be randomly assigned to the intervention group (n=64) or control group (n=64). The intervention group will receive Secukinumab for 24 weeks combined with Huashixiaoyin Decoction for the first 8 weeks, while the control group will receive Secukinumab monotherapy for 24 weeks. The primary outcome is time to relapse during the follow-up period (weeks 24–48). Secondary outcomes include improvements in Psoriasis Area and Severity Index, Investigator’s Global Assessment, Dermatology Life Quality Index, percentage of body surface area affected, and symptom scores based on traditional Chinese medicine syndrome differentiation. Safety will be closely monitored throughout the study. Patients and members of the public were not involved in the design, conduct, reporting, or dissemination plans of this research. RESULTS This study was supported financially by the China’s National High Level Hospital Clinical Research Funding. The trial was registered in December 2024. At the time of submission, participant enrollment has been completed. The follow-up is still ongoing. Data analysis is anticipated to be completed by May 2026. The findings of this study will be shared at conferences both nationally and internationally and will be published in journals that are peer-reviewed. CONCLUSIONS This trial will evaluate the efficacy and safety of Huashixiaoyin Decoction (HSXYD) in combination with Secukinumab for the treatment of moderate-to-severe plaque psoriasis and explore its potential in preventing relapse. The findings will provide valuable clinical evidence on the role of HSXYD as an adjunct therapy, potentially offering a novel approach to sustaining long-term remission in psoriasis patients. By examining its effects, this study may contribute to the development of integrated treatment strategies for psoriasis, ultimately improving patient outcomes and reducing the recurrence of disease after discontinuation of biologic therapy. CLINICALTRIAL This trial was registered in the International Traditional Medicine Clinical Trial Registry(ITMCTR, https://www.chictr.org.cn/) on December 3, 2024. Clinical Trial Number: ITMCTR2025000129.