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Trials
Published in: Trials 1/2022

Open Access 01-12-2022 | Gastritis | Study protocol

Efficacy and safety of Elian Granules in treating chronic atrophic gastritis: study protocol for a randomized, double-blind, placebo-controlled, multicenter clinical trial

Authors: Zhijian Gu, Qingling Jia, Jun Cong, Rong Cen, Yongqi Chen, Chenheng Wu, Biao Gong, Xudong Tang, Jianghong Ling

Published in: Trials | Issue 1/2022

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Abstract

Background

Multifocal atrophic gastritis and intestinal metaplasia are considered to be important links in the gastric precancerous cascade. However, there are no specific drugs for these conditions. Although many studies have shown that traditional Chinese medicine is effective with no serious side effects, these studies have not been scientifically rigorous trials. Our aim is to design a high-quality trial for a Chinese patent medicine, Elian Granules, to investigate its efficacy and safety in treating patients with chronic atrophic gastritis with or without intestinal metaplasia.

Methods

This is a phase II, randomized, double-blind, placebo-controlled, multicenter clinical trial. A total of 240 participants will be assigned to a treatment or placebo control group in a 1:1 ratio. The experimental drug or placebo will be taken with boiling water, two small bags (24.2 g) each time, twice a day, half an hour after a meal, for 24 weeks. The primary outcome is the observation of histological changes in the gastric mucosa of patients with atrophic gastritis with or without intestinal metaplasia after 6 months based on the OLGA/OLGIM staging systems. The secondary outcomes include the assessment of dyspepsia and quality of life based on the dyspepsia symptom score and the quality-of-life scale.

Discussion

This study is designed to evaluate the efficacy and safety of Elian Granules in a randomized, double-blind, placebo-controlled, multicenter manner. This trial may not only provide evidence for a phase III clinical trial, but also an alternative option for the treatment of chronic atrophic gastritis (CAG).

Trial registration

Registry Platform For Evidence-Based Traditional Chinese Medicine ChiMCTR200000392​9. Registered on 13 September 2020
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Metadata
Title
Efficacy and safety of Elian Granules in treating chronic atrophic gastritis: study protocol for a randomized, double-blind, placebo-controlled, multicenter clinical trial
Authors
Zhijian Gu
Qingling Jia
Jun Cong
Rong Cen
Yongqi Chen
Chenheng Wu
Biao Gong
Xudong Tang
Jianghong Ling
Publication date
01-12-2022
Publisher
BioMed Central
Keyword
Gastritis
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06395-6

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