Efficacy and safety of chinese medicine in treating chronic atrophic gastritis based on histopathological changes: protocol for a double-blind, randomized, placebo-controlled, parallel-group, multicenter clinical study

The First Affiliated Hospital of Guangzhou University of Chinese Medicine0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•1. male or female aged 18-65 years;
•2. the diagnostic criteria based on the Chinese Consensus on Chronic Gastritis;
•3. the diagnostic criteria of syndrome differentiation in TCM based on Consensus on diagnosis and treatment of chronic atrophic gastritis with integrated Chinese and Western Medicine;
•4. having a one-minute rapid urease test, a 13C breath test, or a 14C breath test with a negative result within the past month;
•5. communicating normally;
•6. signed informed consent for participation.

•1. participating in another drug trial within the past month;
•2. patients with autoimmune gastritis (type A CAG), peptic ulcer (A1- H2 phase), gastric mucosa high-level intraepithelial neoplasia, gastrointestinal tumors, a history of gastrointestinal cancer, hypertrophic gastritis, ulcerative colitis or other diseases as comorbidities or having a history of gastrointestinal surgery;
•3. patients with serious organ diseases as comorbidities, such as in the heart (cardiac function NYHIII-IV grade, hemodynamically unstable myocardial infarction, etc.), liver (cirrhosis decompensation, etc.), kidney (the uremic syndrome of chronic renal failure, etc.), lung (tuberculosis, acute asthma attacks, etc.), autoimmune system (systemic lupus erythematosus) and so on;
•4. allergic constitution or allergic to a variety of drugs;
•5. patients with serious mental disorders such that they cannot cooperate with researchers, such as schizophrenia, depression, anxiety, dementia and so on;
•6. current pregnancy or lactation;
•7. non-cooperators.

发起方

The First Affiliated Hospital of Guangzhou University of Chinese Medicine