Chronic atrophic gastritis with intestinal metaplasia
Conditions
Interventions
Experimental Group:Fuchun Capsules
Sponsors
Guang'anmen Hospital of the Chinese Academy of Traditional Medicine Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Meets the pathological diagnostic criteria for chronic atrophic gastritis with intestinal metaplasia in Western medicine; (2) Meets the diagnostic criteria for spleen-stomach deficiency syndrome in Traditional Chinese Medicine; (3) Aged 18 to 75 years (inclusive), gender; (4) Volunteers to participate in the clinical trial and has signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with autoimmune gastritis, peptic ulcers, reflux esophagitis, irritable bowel syndrome, gastric cancer, gastrointestinal bleeding, severe dysplasia of the gastric mucosa (based on the most severe lesion site), suspected malignant transformation of gastrointestinal mucosal lesions, or gastrointestinal tumors; (2) Patients who have used Chinese herbal medicines with functions similar to the investigational drug within 1 week prior to enrollment, or who need to take Chinese herbal medicines containing Radix Scrophulariae during the study period (including decoctions and proprietary Chinese medicines); (3) Patients with contraindications for gastroscopy, including severe cardiopulmonary insufficiency, shock, acute corrosive esophagitis, esophageal perforation, gastric perforation, or duodenal perforation; (4) Patients with a history of abdominal surgery (except for uncomplicated appendectomy, cesarean section, endoscopic polypectomy of the stomach, or endoscopic submucosal dissection (ESD)); (5) Patients who have been taking oral aspirin, clopidogrel, warfarin, or other anticoagulant drugs long-term, or who have coagulation disorders; (6) Patients with severe primary diseases of the heart, liver, lungs, kidneys, or blood, or with AST, ALT > 1.5 times the upper limit of normal, or serum creatinine (Scr) > upper limit of normal with clinical significance; (7) Patients with severe mental illness, intellectual disabilities, or language barriers that prevent them from completing questionnaires or recording their symptoms, or who are unwilling to cooperate; (8) Patients with a history of allergies (e.g., allergies to two or more drugs or foods) or a history of allergy to components related to the investigational drug; (9) Patients who need to take non-steroidal anti-inflammatory drugs (excluding topical medications), folic acid, vitamins, selenium-containing formulations, or related Chinese herbal medicines long-term; (10) Patients with a history of alcohol abuse or drug abuse; (11) Patients who are planning pregnancy, pregnant (positive pregnancy test in women of childbearing age), or breastfeeding; (12) Patients who have participated in or are currently participating in other drug clinical trials within the past 3 months; (13) Patients deemed unsuitable for participation in the clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The efficacy rate of the overall score for intestinal metaplasia under endoscopy.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The efficacy rate of the overall score for intestinal metaplasia under endoscopy.;During gastroscopy, the overall score and efficacy rate of gastric mucosal histopathology (including atrophy and intestinal metaplasia).;Overall and efficacy rate of gastric mucosal atrophy during gastroscopy.;The efficacy rate at different lesion sites.;Single Symptom Evaluation;Gastric mucosa intestinal metaplasia (OLGIM) staging;Gastric Mucosal Atrophy (OLGA) Staging;TCM syndrome score;Gastrointestinal Function Indices;Rate of dysplasia, overall score, and efficacy rate.; | — |
Countries
China
Contacts
Public ContactLiu Zhen
Guang'anmen Hospital of the Chinese Academy of Traditional Medicine Sciences
Outcome results
None listed