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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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000041504
Enrollment
Unknown
Registered
2020-12-27
Start date
2021-04-30
Completion date
Unknown
Last updated
2022-06-20

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 Zhejiang University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Histopathology of gastric mucosal atrophy;

Secondary

MeasureTime frame
OLGA;Grading of endoscopic gastritis;Main clinical symptoms;

Countries

China

Contacts

Public ContactLyu Bin

The Ethics Committee of the First Affiliated Hospital of Zhejiang University of Chinese Medicine

lvbin@medmail.com.cn+86 571 86620281

Outcome results

None listed

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