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

ABSTRACT Introduction: Condyloma 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 analysis: A 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 dissemination: This 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 number: ChiCTR2300071609; www.chictr.org.cn;Registered on April19, 2023(first version). Key words: Randomized trial, Condyloma acuminate, photodynamic therapy, Wei Ren Anti-Wart Formula ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial ChiCTR2300071609 ### Funding Statement Shanghai Municipal Health Commission Health Industry Clinical Research Specialization(20224Y0056,20214Y0175),Shanghai Sailing Program(no.20YF1450500) ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: the Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine gave ethical approval for this work I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors All data produced in the present work are contained in the manuscript