Clinical efficacy of Danggui Sini Decoction for treatment of lower limb arteriosclerosis obliterans: A randomized controlled trial

doi:10.5662/wjm.v16.i2.115003

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World Journal of Methodology

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2222-0682

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

Randomized Controlled Trial

Copyright: ©Author(s) 2026. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution-NonCommercial (CC BY-NC 4.0) license. No commercial re-use. See permissions. Published by Baishideng Publishing Group Inc.

World J Methodol. Jun 20, 2026; 16(2): 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

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 23.4 Hours

Abstract

BACKGROUND

Endovascular revascularization for lower limb arteriosclerosis obliterans (ASO) is often limited by long-term restenosis. This study evaluated whether the traditional Chinese medicine formula Danggui Sini Decoction (DGSD) could improve mid-term outcomes when combined with the standard procedure.

AIM

To investigate the clinical efficacy of DGSD combined with endovascular revascularization in the treatment of ASO and its impact on patients’ quality of life.

METHODS

A total of 38 ASO patients treated at Zhangjiajie People’s Hospital from January 2023 to January 2025 were selected and randomly divided into a control group and an experimental group, with 19 patients in each group. The control group received conventional endovascular revascularization and basic treatment, while the experimental group was treated with DGSD in addition to the control group’s treatment. The clinical effectiveness rate, freedom from clinically driven target lesion revascularization, primary patency rate, and quality of life scores were compared between the two groups.

RESULTS

Within one month postoperatively, there was no significant difference in clinical effectiveness between the two groups (experimental group: 78.95% vs control group: 84.21%, P > 0.05), but the improvement in quality of life scores in the experimental group was significantly better than that of the control group (P < 0.05). At six months postoperatively, the clinical effectiveness rate in the experimental group was significantly higher than that of the control group (94.74% vs 73.68%, P < 0.05). The experimental group had a higher rate of freedom from clinically driven target lesion revascularization compared to the control group, but the difference was not statistically significant (100% vs 84.21%, P > 0.05). The primary patency rate in the experimental group was significantly better than that of the control group (P < 0.05).

CONCLUSION

DGSD combined with endovascular revascularization can significantly improve the mid-term clinical efficacy in ASO patients, reduce the risk of lower limb arterial re-occlusion, and enhance quality of life, demonstrating significant clinical application value.

Keywords: Arteriosclerosis obliterans; Danggui Sini Decoction; Endovascular revascularization; Clinical efficacy; Primary patency rate; Quality of life; Target lesion revascularization

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 improvement in quality of life, suggesting that DGSD is a valuable complementary treatment for improving vascular patency and patient well-being in arteriosclerosis obliterans management.