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The treatment of chronic atrophic gastritis by Moluodan: a randomized, double-blind, parallel controlled, multicenter clinical trial

The treatment of precancerous lesions of gastric cancer—chronic atrophic gastritis by Moluodan: a randomized, double-blind, parallel controlled, multicenter clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016087
Enrollment
Unknown
Registered
2018-05-10
Start date
2017-11-03
Completion date
Unknown
Last updated
2022-08-08

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

Conditions

chronic atrophic gastritis

Interventions

treatment group:Moluodan, Moluodan analogue and folic acid analogue
High dose control group:Moluodan, Moluodan and folic acid analogue
Positive drug control group:Moluodan analogue, Moluodan analogue and folic acid
Combined control group:Moluodan, Moluodan analogue and folic acid

Sponsors

Renji Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18-70 years old, male or female; 2. Patients who meet the diagnostic criteria of Western medicine for chronic atrophic gastritis with moderate to severe atrophy and/or mild dysplasia, moderate to severe intestinal metaplasia, and negative for Helicobacter pylori (at least one of C13 or C14 breath test is required); 3. 2 experts from pathology department should diagnose the patients (pathological reading), and the 2 experts can agree on it; 4. Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Combined with peptic ulcer, moderate or severe dysplasia of gastric mucosa or pathological diagnosis of suspected malignancy; 2. With a history of serious digestive system diseases or abdominal operation; 3. Women in pregnancy and lactation; 4. Combined with serious heart, lung, hematopoietic, malignant tumor and other primary diseases, patients with severe diabetes, chronic liver and kidney dysfunction, including liver function damage ALT > 1.5 times the upper limit of normal value, or renal function damage serum creatinine (Cr) > 1.5 times the upper limit of normal value; 5. Platelet count below 0.75 times the lower limit of normal value; 6. Patients with disabilities prescribed by law (blindness, deafness, dumb, mental retardation, mental disorder, physical disability); 7. Patients with a history of alcoholism; 8. Allergic constitution or history of allergy to multiple drugs (more than two or known components in the drug); 9. Participated in the clinical trials of other drugs within the past 4 weeks; 10. According to the researcher's judgment, it is easy to cause loss of follow-up, or other reasons that should not be selected.

Design outcomes

Primary

MeasureTime frame
Biopsy pathology results;

Secondary

MeasureTime frame
Endoscopic diagnosis;Pepsinogen and Gastrin 17;HP detection;stomach age;

Countries

China

Contacts

Public ContactJingyuan Fang

Renji Hospital, Shanghai Jiaotong University School of Medicine

13046678061@163.com+86 13918386561

Outcome results

None listed

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