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A clinical trial to study and compare the effect of two different antibiotic regimen in treating Helicobacter pylori infection.

High Dose Dual Therapy Vs. Standard Triple Therapy in the Eradication of Helicobacter Pylori: A Randomized Controlled Trial. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/073256
Enrollment
168
Registered
2024-09-03
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Health Condition 1: K279- Peptic ulcer, site unspecified, unspecified as acute or chronic, without hemorrhage or perforation

Interventions

Intervention1: Group A receiving High Dose Dual Therapy (the test group): Group A participants will receive cap omeprazole 20mg four times a day and cap amoxicillin 1g four times a day for 14 days. Th

Sponsors

Intramural Research Fund Committee
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients more than 18 years of age who undergo esophagogastroduodenoscopy for the investigation of gastrointestinal symptoms in the Department of Surgery, JIPMER and are tested positive for Helocobacter pylori infection.

Exclusion criteria

Exclusion criteria: 1. Previous eradication therapy. 2. Patients who have used antibiotics within the previous 4 weeks. 3. Past history of developing allergy to any antibiotic used in the study. 4. Patients who have undergone gastrectomy. 5. Coexisting of severe concomitant medical illness. 6. Pregnancy or lactating women. 7. Patients diagnosed with any malignancies. 8. Patients with portal gastropathy.

Design outcomes

Primary

MeasureTime frame
The study design is designed as a superiority trial. Aim is to compare the effectiveness of High Dose Dual Therapy in eradicating Helicobacter pylori infection. Aim is to prove that the proposed regimen is superior to the Standard Triple therapy in eradiacting the Helicobacter pylori Infection, with a level of significance of 5 percent and margin of superiority of 2 percent.Timepoint: 6 weeks

Secondary

MeasureTime frame
To compare the compliance & adverse effects of High Dose Dual Therapy & Standard Triple Therapy.Timepoint: 2 weeks

Countries

India

Contacts

Public ContactDr Anandhi A

JMedical Education and Research

drvikramkate@gmail.com9487781661

Outcome results

None listed

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