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World J Methodol. Jun 20, 2026; 16(2): 115003
Published online Jun 20, 2026. doi: 10.5662/wjm.v16.i2.115003
Published online Jun 20, 2026. doi: 10.5662/wjm.v16.i2.115003
Clinical efficacy of Danggui Sini Decoction for treatment of lower limb arteriosclerosis obliterans: A randomized controlled trial
Yan-Bo Fu, Feng Yan, Hong-Jiang Zhu, Cong Wang, Department of Vascular Interventional Surgery, Zhangjiajie People’s Hospital, Zhangjiajie 415000, Hunan Province, China
Co-first authors: Yan-Bo Fu and Feng Yan.
Author contributions: Fu YB and Yan F were responsible for conceptualization, methodology, investigation, and writing of the original draft as co-first authors; Zhu HJ was responsible for supervision, project administration, manuscript review and editing, and funding acquisition; Wang C was responsible for methodology, validation, and formal analysis; all of the authors have read and approved the final version of the manuscript to be published.
Supported by 2023 Zhangjiajie Municipal Special Fund for Sci-Tech Development, No. 7.
Institutional review board statement: The study was conducted according to the guidelines of the Declaration of Helsinki and approved by the Institutional Review Board of Zhangjiajie People’s Hospital, No. 2023-LCYJ-076.
Clinical trial registration statement: This study was registered at the Chinese clinical trial registry (https://www.medicalresearch.org.cn/).
Informed consent statement: All participants provided informed consent prior in enrollment.
Conflict-of-interest statement: All authors declare no conflict of interest in publishing the manuscript.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Data sharing statement: The data that support the findings of this study are not publicly available due to containing information that could compromise research participant privacy. However, data are available from the corresponding author Zhu HJ upon reasonable request and with permission of the institutional review board/ethics committee.
Corresponding author: Hong-Jiang Zhu, MD, Department of Vascular Interventional Surgery, Zhangjiajie People’s Hospital, No. 192 Guyong Road, Yongding District, Zhangjiajie 415000, Hunan Province, China. 13028176178@163.com
Received: October 11, 2025
Revised: November 19, 2025
Accepted: February 2, 2026
Published online: June 20, 2026
Processing time: 200 Days and 23.5 Hours
Revised: November 19, 2025
Accepted: February 2, 2026
Published online: June 20, 2026
Processing time: 200 Days and 23.5 Hours
Core Tip
Core Tip: This randomized controlled trial demonstrates that adjunctive therapy with Danggui Sini Decoction (DGSD), a classic traditional Chinese medicine formula, significantly enhances the mid-term outcomes of endovascular revascularization for arteriosclerosis obliterans. At six months, the DGSD group showed superior clinical effectiveness (94.74% vs 73.68%) and primary patency rates compared to the control group. The combination therapy also led to a greater impro