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Efficacy and safety of Sucralfate Suspensoid Gel in the treatment of Helicobacter pylori associated gastritis after eradication with standard quadruple therapy: a multicenter randomized controlled trial

Efficacy and safety of Sucralfate Suspensoid Gel in the treatment of Helicobacter pylori associated gastritis after eradication with standard quadruple therapy: a multicenter randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000041211
Enrollment
Unknown
Registered
2020-12-22
Start date
2020-12-28
Completion date
Unknown
Last updated
2021-03-08

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

Conditions

Helicobacter pylori associated gastritis

Interventions

A:Rabeprazole 20 mg, amoxicillin 1000 mg, clarithromycin 500 mg and colloidal bismuth pectin 200 mg, all twice daily for 14 days
B:After the use of rabeprazole 20 mg, amoxicillin 1000 mg, clarithromycin 500 mg and colloidal bismuth pectin 200 mg, all twice daily for 14 days, take Sucralfate Suspensoid Gel twice a day for 14 day

Sponsors

Shandong Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients, aged 18-60 years; 2. The patients who did not take antibiotics, bismuth and traditional Chinese medicine in 4 weeks before treatment did not take PPI, H2 receptor antagonist and other drugs in 2 weeks; 3. Patients diagnosed as HP positive by C13 or C14 urea breath test and rapid urease test; 4. The patients who knew and agreed to participate in this study had complete medical records and follow-up records; 5. Patients without any Helicobacter pylori eradication treatment within half a year.

Exclusion criteria

Exclusion criteria: 1. Patients with history of diabetes, hypertension and kidney disease; 2. Patients with digestive tract obstruction; 3. Patients with severe heart, lung and liver dysfunction; 4. Patients with hypophosphatemia; 5. Patients with malignant tumor; 6. Patients who have received hemodialysis treatment; 7. Patients who had received parenteral nutrition treatment; 8. Pregnant or lactating women or women of childbearing age without effective contraceptive measures; 9. Patients allergic to sucralfate or drugs in this study; 10. Patients who need to take tetracyclines during the study period; 11. Patients with mental illness; 12. Subjects unable to complete the test according to the test requirements; 13. Subjects without legal capacity or insight; 14. Subjects who participated in any drug clinical trial three months before entering the study.

Design outcomes

Secondary

MeasureTime frame
Relief rate of digestive tract symptoms;The incidence of adverse reactions (including bitter mouth, taste disorder, black tongue coating, nausea, diarrhea, anorexia, gray-black stool, etc.);

Primary

MeasureTime frame
Assessment of mucosal damage;Hp eradication rate after treatment;

Countries

China

Contacts

Public ContactZhang Chunqing

Shandong Provincial Hospital

13583168661@163.com+86 531-68773293

Outcome results

None listed

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