Study Comparing Two Treatments (Vonoprazan and Esomeprazole) for H. pylori Infection in Patients in Eastern India

Comparison of Safety and Efficacy of Vonoprazan based High dose amoxicillin dual therapy with Esomeprazole based Standard triple therapy for H pylori eradication in Eastern India: A single centre double blind Randomized trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/106498

Enrollment

530

Registered

2026-03-18

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Health Condition 1: K318- Other specified diseases of stomach and duodenum

Interventions

Intervention1: Vonoprazan based High dose amoxicillin dual therapy(HDDT): 14days of Vonoprazan-based HDDT, comprising Vonoprazan fumarate tablets 20 mg Two times daily and amoxicillin capsules 1000 mg

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age range of 18 to 90 years 2. Confirmed H. pylori infection by at least one of the following diagnostic methods: Carbon-14 urea breath test (14C UBT) or immuno-histochemical staining of biopsy specimens. When the disintegrations per minute (DPM) more than 49 (14C), H. pylori was considered positive 3. No use of antibiotics, bismuth, or Indian traditional medicines within four weeks prior to 14C-UBT, and no use of H2 receptor antagonists, PPIs, P-CAB, or other drugs affecting H. pylori activity within two weeks before 14C UBT 4. No prior history of H. pylori eradication therapy

Exclusion criteria

Exclusion criteria: 1. Patients with serious diseases or clinical conditions that may interfere with the evaluation of study results, such as severe heart, liver, lung, and renal insufficiency, or compromised immunity 2. Patients with allergies to penicillin or any study-related medications 3.Patients with mental illness or communication disorders 4. Pregnant or lactating patients 5. Patients with severe gastrointestinal diseases, including gastrointestinal tumors, gastrointestinal bleeding, or other organic diseases; and 6. Patients concurrently participating in other clinical trials

Design outcomes

Primary

Measure	Time frame
To compare eradication rates of 14-day Vonoprazan based High dose amoxicillin dual therapy with 14-day Esomeprazole Based Standard Triple therapy in H. pylori Infected patient.Timepoint: proportion of H. pylori negative patients in specific groups at least 4 weeks after treatment completion	—

Secondary

Measure	Time frame
To compare adverse events, compliance, symptom relief and cost-effectiveness of 14-day Vonoprazan based High dose amoxicillin dual therapy with 14-day Esomeprazole Based Standard Triple therapy for H. pylori eradicationTimepoint: At least 4 weeks after treatment completion	—

Countries

India

Contacts

Public ContactDr Sanjib Kumar Kar

Indian Institute of Gastroenterology and Hepatology

drsanjibkar@yahoo.com07978900184

Outcome results

None listed

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