Efficacy and Safety of <italic style="font-style: italic">Aurantii Fructus Immaturus</italic> Flavonoid Tablets in Patients with Functional Dyspepsia: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ⅲ Clinical Trial

YANG Xiao-nan; XIANG Jin; GONG Mei; YU Bin; ZHOU Zheng-hua; LI Hui-zhen; GE Yan; XIE Jing-ri

doi:10.1007/s11655-025-3834-9

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Efficacy and Safety of Aurantii Fructus Immaturus Flavonoid Tablets in Patients with Functional Dyspepsia: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ⅲ Clinical Trial

Original Article | Updated：2026-02-14

- Efficacy and Safety of Aurantii Fructus Immaturus Flavonoid Tablets in Patients with Functional Dyspepsia: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ⅲ Clinical Trial
- Efficacy and Safety of Aurantii Fructus Immaturus Flavonoid Tablets in Patients with Functional Dyspepsia: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ⅲ Clinical Trial
- Chinese Journal of Integrative Medicine 2026年32卷第3期页码：204-212
- Affiliations：
  
  1.Integrated Traditional Chinese and Western Medicine, West China Hospital of Sichuan University, Chengdu (610441), China
  2.GCP Center, West China Hospital of Sichuan University, Chengdu (610441), China
  3.Department of Gastroenterology, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu (610072), China
  4.Department of Gastroenterology, the First Affiliated Hospital of Hunan University of Chinese Medicine, Changsha (410021), China
  5.Department of Spleen and Stomach, the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin (300192), China
  6.Department of Spleen and Stomach, the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin (300150), China
  7.Department of Gastroenterology, Guangdong Second Hospital of Traditional Chinese Medicine, Guangzhou (510095), China
  8.Department of Hepatosplenomegaly, the First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine, Harbin (150040), China
- Author bio：
  
  Prof. XIANG Jin, E-mail: xiangjin@wchscu.cn
- Funds：
- DOI：10.1007/s11655-025-3834-9
  中图分类号：
- 录用：2025-01-22，
  
  网络首发：2026-01-05，
  
  纸质出版：2026-03
- Accepted：
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YANG Xiao-nan, XIANG Jin, GONG Mei, 等. Efficacy and Safety of Aurantii Fructus Immaturus Flavonoid Tablets in Patients with Functional Dyspepsia: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ⅲ Clinical Trial[J]. Chinese Journal of Integrative Medicine, 2026,32(3):204-212.

YANG Xiao-nan, XIANG Jin, GONG Mei, et al. Efficacy and Safety of Aurantii Fructus Immaturus Flavonoid Tablets in Patients with Functional Dyspepsia: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ⅲ Clinical Trial[J]. Chinese Journal of Integrative Medicine, 2026, 32(3): 204-212.
YANG Xiao-nan, XIANG Jin, GONG Mei, 等. Efficacy and Safety of Aurantii Fructus Immaturus Flavonoid Tablets in Patients with Functional Dyspepsia: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ⅲ Clinical Trial[J]. Chinese Journal of Integrative Medicine, 2026,32(3):204-212. DOI： 10.1007/s11655-025-3834-9.

YANG Xiao-nan, XIANG Jin, GONG Mei, et al. Efficacy and Safety of Aurantii Fructus Immaturus Flavonoid Tablets in Patients with Functional Dyspepsia: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ⅲ Clinical Trial[J]. Chinese Journal of Integrative Medicine, 2026, 32(3): 204-212. DOI： 10.1007/s11655-025-3834-9.

摘要

Abstract

Objective:

To assess the efficacy and safety profile of

Aurantii Fructus Immaturus

flavonoid (AFIF) tablets in the treatment of patients with functional dyspepsia (FD).

Methods:

In this phase Ⅲ

randomized

controlled clinical trial

participants diagnosed with FD from 7 medical centers across China were assigned by stratified block randomization to either AFIF treatment group (3 AFIF tablets

0.29 g per tablet) or placebo group on the same schedule in a 3:1 ratio. The primary endpoint was the complete disappearance of 4 core FD symptoms

including postprandial fullness

early satiety

upper abdominal pain

and upper abdominal burning

following a 4-week treatment regimen (3 times daily). Secondary endpoints included the individual symptom disappearance rates and gastric emptying function after 4 weeks

as well as the disappearance rates for all 4 individual symptoms of FD at 4 weeks after treatment. Subgroup analyses included 3 clinical symptoms and 4 Chinese medicine patterns. Safety assessments included monitoring treatment-emergent adverse events (AEs)

serious adverse events (SAEs)

intervention-related AEs

and any AEs leading to discontinuation.

Results:

Of the enrolled patients

299 in the AFIF gr

oup and 99 in the control group were induded in the full analysis set (FAS) and safety set (SS). After 4 weeks of treatment

the complete disappearance of all 4 core FD symptoms was achieved in 31.44% (94 cases) of patients in the AFIF group compared to 6.06% (6 cases) in the placebo group (

0.01). At 4 weeks after end of treatment

the rates of symptom disappearance were 23.43% (67 cases) in the AFIF group and 2.22% (2 cases) in the placebo group (

0.01). Individual symptom disappearance rates were significantly higher in the AFIF group at both week 4 and 4 weeks after treatment (all

0.01). Additionally

the patients in the AFIF group exhibited a significantly greater improvement in gastric emptying at 2 h post-meal [66.55% (50.03

84.55)

]

compared to the placebo group [51.10% (44.75

68.93)

= 0.027

]

. At weeks 4 and 4 weeks after treatment

in the FAS

the disappearance rates of all 4 core FD symptoms remained higher in the AFIF group compared to the placebo group (all

0.05). The per protocol set results similarly aligned with those observed in the FAS. Intervention-related AEs were reported in 6.02% (18 cases) of the AFIF group and 8.08% (8 cases) in the placebo group

with no SAEs recorded in either group. The patients in the AFIF group showed significantly higher complete symptom resolution rates of all 4 core FD symptoms at 4 weeks and 4 weeks after treatment across most subgroups

compared to the placebo group (all

0.05). All AEs related to AFIF Tablets were mild.

Conclusion:

AFIF tablets demonstrated robust efficacy in alleviating the symptoms of FD

with a favorable safety profile. (Registration No. CTR20132482)

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Efficacy and Safety of Aurantii Fructus Immaturus Flavonoid Tablets in Patients with Functional Dyspepsia: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ⅲ Clinical Trial

Efficacy and Safety of Aurantii Fructus Immaturus Flavonoid Tablets in Patients with Functional Dyspepsia: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ⅲ Clinical Trial

DOI：10.1007/s11655-025-3834-9

摘要

Abstract

关键词

Keywords

references