Skip to content

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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000004120
Enrollment
Unknown
Registered
2020-12-01
Start date
2020-12-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic atrophic gastritis

Interventions

Sponsors

The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
the scores of histopathological and endoscopic valuables;

Secondary

MeasureTime frame
Different TCM syndromes indicator;evaluation of gastroscopy;Symptom evaluation indicator;Evaluation of anxiety and depression;Quality of life evaluation;

Countries

China

Contacts

Public ContactLi Peiwu

Guangzhou University of Traditional Chinese Medicine

doctorlipw@gzucm.edu.cn+86 18926154883

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026