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
- Conditions
- chronic atrophic gastritis
- Registration Number
- ITMCTR2000004120
- Lead Sponsor
- The First Affiliated Hospital of Guangzhou University of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the scores of histopathological and endoscopic valuables;
- Secondary Outcome Measures
Name Time Method Different TCM syndromes indicator;evaluation of gastroscopy;Symptom evaluation indicator;Evaluation of anxiety and depression;Quality of life evaluation;