Chronic Atrophic Gastritis with Precancerous Lesions
Conditions
Interventions
Experimental Group:Weipixiao Granules, oral administration. 1 bag dissolved in water, tid for 24 weeks.
Control Group:Weipixiao Granules Placebo, oral administration. 1 bag dissolved in water, tid for 24 weeks.
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-70 years, regardless of gender; (2) Confirmed diagnosis of atrophic gastritis with intestinal metaplasia by gastroscopy and histopathological examination, with OLGA and OLGIM stages III or above; (3) TCM syndrome differentiation consistent with Qi-Yin deficiency syndrome, or concurrent Qi stagnation, blood stasis, or stomach heat syndromes; (4) Negative Helicobacter pylori (Hp) test via rapid urease test or breath test within the past month; (5) Signed informed consent and voluntary participation.
Exclusion criteria
Exclusion criteria: (1) Comorbidities including peptic ulcer, gastroesophageal reflux disease (reflux esophagitis Los Angeles grade B or above), gastric polyps, or hiatal hernia; (2) Presence of high-grade intraepithelial neoplasia, suspected malignant gastrointestinal lesions, or gastrointestinal tumors; (3) History of malignancy treated with surgery/radiotherapy/chemotherapy within 5 years, or abdominal surgery (excluding uncomplicated appendectomy, cesarean section, endoscopic polypectomy, or ESD); (4) Severe organ dysfunction affecting survival quality (e.g., cardiac NYHA class III-IV, decompensated liver cirrhosis, chronic renal failure, active pulmonary tuberculosis, systemic lupus erythematosus in active phase); (5) History of hypersensitivity or multiple drug allergies; (6) Severe psychiatric disorders (e.g., schizophrenia, anxiety, depression) with HADS anxiety/depression score =11; (7) Pregnancy, lactation, or women with childbearing potential; (8) Participation in other clinical trials within 4 weeks prior to enrollment; (9) Long-term use of NSAIDs (excluding topical), folic acid, vitamins, selenium-containing agents, or related Chinese medicines; (10) Investigator-determined ineligibility.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rate of histopathological examination of gastric mucosa (including atrophy and intestinal metaplasia); | — |
Secondary
| Measure | Time frame |
|---|---|
| Total score of histopathological examination of gastric mucosa (including atrophy and intestinal metaplasia);Total score and effective rate of intestinal metaplasia;Overall and efficacy rate of gastric mucosal atrophy during gastroscopy.;The efficacy rate at different lesion sites.;Single Symptom Evaluation;OLGIM staging of intestinal metaplasia and OLGA staging of gastric atrophy;TCM syndrome score;Gastrointestinal Function Indices;Incidence of intraepithelial neoplasia; | — |
Countries
China
Contacts
Public ContactLiu Tianwen
Guangdong Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed