Chronic atrophic gastritis (CAG) is a significant precursor to gastric cancer, particularly in regions with high Helicobacter pylori infection rates. Despite the known benefits of H. pylori eradication in reducing gastric cancer risk, there remains a lack of effective treatments for atrophic gastritis and intestinal metaplasia. Elian Granules, a Chinese patent medicine used for over 20 years, has shown potential in preliminary studies to improve symptoms and possibly reverse gastric mucosal changes in patients with CAG.
The trial is designed as a randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of Elian Granules. Participants, aged 18-70, diagnosed with CAG and negative for H. pylori, will be randomly assigned to receive either Elian Granules or a placebo for 24 weeks. The primary outcome is the histological assessment of gastric mucosal biopsies, with secondary outcomes including endoscopic examination, dyspepsia symptoms, quality of life, and safety assessments.
Eligibility criteria include a pathological stage of OLGA-II/III, confirmed by two pathology experts, and the exclusion of patients with severe diseases or those who have participated in other clinical trials recently. The study also outlines detailed plans for data management, participant retention, and safety monitoring, including adverse event reporting and interim analyses.
This trial represents a significant step towards identifying a potentially effective treatment for CAG, addressing a critical gap in the management of this precancerous condition. The comprehensive approach to evaluating both efficacy and safety outcomes underscores the importance of this research in advancing patient care in the field of gastroenterology.
