The randomized double-blind double-simulation and parallel-controlled clinical trial study on the efficacy and safety of Weifuchuni Capsule in the treatment of chronic atrophic gastritis
- Conditions
- Chronic atrophic gastritis
- Registration Number
- ITMCTR2000004204
- Lead Sponsor
- The First Affiliated Hospital of Zhejiang University of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Patients meeting the diagnostic criteria of chronic atrophic gastritis (Olga stage II and above);
2. Patients aged from 18 to 65 years old (including 18 and 65 years old) are not limited in gender;
3. The patients who voluntarily participate in this clinical trial should have informed consent and sign the informed consent form.
1. Patients with peptic ulcer, gastroesophageal reflux disease and other diseases requiring PPI treatment;
2. Patients with high grade intraepithelial neoplasia of gastric mucosa or suspected malignant change by pathological diagnosis;
3. HP positive patients and those who have received anti HP treatment and related treatment in the past four weeks;
4. Drug history: Taking the following drugs within one month before specimen collection:
(1) Antibiotics (oral, intramuscular and intravenous);
(2) Microecological agents (probiotics, prebiotics, synbiotics, etc.);
(3) Various drugs (proton pump inhibitors and H2 receptor antagonists, etc.) that inhibit gastric acid secretion;
(4) Cytokines, immunosuppressants and cytotoxic agents, etc;
(5) Hormones;
(6) Other drugs affecting gastric flora;
5. Patients with abnormal renal function and clinical significance, liver function ALT >= 2 times the upper limit of normal reference value;
6. Patients with serious primary heart, liver, kidney, lung, blood and nervous system diseases;
7. Patients with mental retardation or psychosis;
8. Patients with suspected or true history of alcohol or drug abuse;
9. Pregnant and lactating women or women and men with family planning within one year;
10. Patients with known or suspected allergic history to the test drug and its excipients;
11. Patients who have participated in other clinical trials in recent 3 months;
12. Patients considered unsuitable by the researchers to participate in this clinical trial.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Histopathology of gastric mucosal atrophy;
- Secondary Outcome Measures
Name Time Method OLGA;Grading of endoscopic gastritis;Main clinical symptoms;