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 Gastroenterol. Nov 14, 2026; 32(42): 122218
Published online Nov 14, 2026. doi: 10.3748/wjg.122218
Published online Nov 14, 2026. doi: 10.3748/wjg.122218
Aurantii Fructus Immaturus Flavonoid tablets for functional dyspepsia: A multicenter, double-blind, dose-exploring IIb randomized controlled trial
Qin Wan, Beijing University of Chinese Medicine Third Affiliated Hospital, Beijing 100029, China
Yi-Ying Wang, Mei Han, Center for Evidence-Based Medicine, Beijing University of Chinese Medicine, Beijing 100029, China
Xin-Yu Li, School of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China
Ying Liu, Department of Medical Affairs, Jiangxi Qingfeng Pharmaceutical Co., Ltd, Nanchang 341000, Jiangxi Province, China
Bo-Yi Jia, Department of Spleen and Stomach Diseases, Fangshan Traditional Medical Hospital of Beijing, Beijing 102400, China
Co-first authors: Qin Wan and Yi-Ying Wang.
Author contributions: Wan Q and Wang YY contributed equally as co-first authors; Han M conceptualized and supervised the study, developed the methodology; Han M and Wan Q contributed to writing and editing the original draft; Wan Q, Wang YY, Li XY, and Jia BY contributed to data analysis; Wang YY, Li XY, and Jia BY conducted the investigation; Liu Y participated in the revision and development of the study protocol. All authors reviewed and approved the final version.
AI contribution statement: The authors take full responsibility and accountability for all content of this manuscript, including any portions for which AI tools (specifically DeepSeek-V3) were used as assistive technologies. All AI-assisted outputs were carefully reviewed, validated, and approved by the authors. AI tools were not used to generate original scientific data, perform independent scientific analyses, or draw scientific conclusions.
Supported by High-Level Traditional Chinese Medicine Key Subjects Construction Project of the National Administration of Traditional Chinese Medicine - Evidence-Based Traditional Chinese Medicine, No. zyyzdxk-2023249.
Institutional review board statement: This study was approved by the Clinical Trial Ethics Committee of West China Hospital of Sichuan University, No. 4/2011.
Clinical trial registration statement: This study was registered at the ISRCTN registry (https://www.isrctn.com/) under the identifier ISRCTN10266781.
Informed consent statement: Written informed consent was obtained from all participants prior to their enrollment in the study.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
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 presented in this study are available upon reasonable request from the corresponding author. The data are not publicly available due to privacy and ethical restrictions.
Corresponding author: Mei Han, Center for Evidence-Based Medicine, Beijing University of Chinese Medicine, No. 11 Beisanhuan East Road, Chaoyang District, Beijing 100029, China.
Received: April 14, 2026
Revised: June 3, 2026
Accepted: July 3, 2026
Published online: November 14, 2026
Processing time: 161 Days and 12.4 Hours
Revised: June 3, 2026
Accepted: July 3, 2026
Published online: November 14, 2026
Processing time: 161 Days and 12.4 Hours
Core Tip
Core Tip: This placebo-controlled, randomized phase IIb trial identified, for the first time, the optimal clinical dose of Zhi Shi Flavonoids for functional dyspepsia. Both the medium- and high-dose Aurantii Fructus Immaturus Flavonoid groups showed significant improvement in functional dyspepsia symptoms after 4 weeks compared with the placebo group, with good tolerability and no serious adverse events. These findings inform optimal dosing for phase III trials and support the in