Wei Ren Anti-Wart Formula combined with photodynamic therapy for Condyloma acuminate: a double-blind, randomized, parallel-group trial

Abstract

ABSTRACTIntroductionCondyloma acuminate (CA) is a chronic disease with a high rate of recurrence which has a detrimental impact on patients’ physical and mental health, as well as their quality of life and socioeconomic advancement. Photodynamic therapy is a less invasive and selective intervention for CA, but its safety and high price limit its utilization. Wei Ren Anti-Wart Formula (WRAWF), is a promising Chinese medicine for CA, however, the evidence of its effectiveness and safety is scarcely. This trial aimed to evaluate the clinical effectiveness, safety, and recurrence management of WRAWF combined with photodynamic in the CA patients.Methods and analysisA double-blind, randomized, parallel-group trial was designed. Participants will recruit in the Yue Yang Traditional Chinese Medicine Hospital, Shanghai University of Traditional Chinese Medicine from May 1, 2024, to December 31, 2025. The sample size is 148 CA patients (74 in each group), will randomly divide into the trial and control groups. followed up at weeks 6, 10, and 14 after the 2-week treatment period. The recurrence rate will be set as the primary outcome. The visual analogue scale (VAS) scores of pain, the rate of infection, superficial scarring, and the type, severity, and incidence of adverse events will be carefully documented at 0,1,2,6,10,14 weeks.Ethics and disseminationThis trial has approved by the Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine (No. 2023-023). Meanwhile, informed consent was provided by all patients conducted in accordance with the Declaration of Helsinki.Trial registration numberChiCTR2300071609;www.chictr.org.cn;Registered on April19, 2023(first version).