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CTRI Number  CTRI/2026/03/106498 [Registered on: 18/03/2026] Trial Registered Prospectively
Last Modified On: 18/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study Comparing Two Treatments (Vonoprazan and Esomeprazole) for H. pylori Infection in Patients in Eastern India 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjib Kumar Kar 
Designation  Senior Consultant 
Affiliation  Indian Institute of Gastroenterology and Hepatology 
Address  Room No 209, Department Of Gastroenterology, Endoscopy Division,Service Road NH 16 Unit27 Gandarpur,sikharpur,Cuttack.

Cuttack
ORISSA
753003
India 
Phone  07978900184  
Fax    
Email  drsanjibkar@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sanjib Kumar Kar 
Designation  Senior Consultant 
Affiliation  Indian Institute of Gastroenterology and Hepatology 
Address  Room No 209, Department Of Gastroenterology, Endoscopy Division,Service Road NH 16 Unit27 Gandarpur,sikharpur,Cuttack.


ORISSA
753003
India 
Phone  07978900184  
Fax    
Email  drsanjibkar@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sanjib Kumar Kar 
Designation  Senior Consultant 
Affiliation  Indian Institute of Gastroenterology and Hepatology 
Address  Room No 209, Department Of Gastroenterology, Endoscopy Division,Service Road NH 16 Unit27 Gandarpur,sikharpur,Cuttack.


ORISSA
753003
India 
Phone  07978900184  
Fax    
Email  drsanjibkar@yahoo.com  
 
Source of Monetary or Material Support  
Indian Institute of Gastroenterology and Hepatology,Service Road NH 16 Unit27 Gandarpur,sikharpur,Cuttack,753003,Odisha,India 
 
Primary Sponsor  
Name  Dr Sanjib Kumar Kar 
Address  Room No 209, Department Of Gastroenterology, Endoscopy Division,Service Road NH 16 Unit27 Gandarpur,sikharpur,Cuttack,Odisha,India,753003 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sanjib Kumar Kar  Indian Institute Of Gastroenterology And Hepatology  Room No 209, Department Of Gastroenterology, Endoscopy Division,Service Road NH 16 Unit27 Gandarp ur,sikharpur,Cuttack Cuttack, ORISSA
Cuttack
ORISSA 
07978900184

drsanjibkar@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee,Indian Institute of Gastroenterology and Hepatology  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K318||Other specified diseases of stomach and duodenum,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Esomeprazole Based triple therapy group  The 14days of standard Esomeprazole Based triple therapy group will receive, esomeprazole enteric-coated tablets 20 mg twice daily, amoxicillin capsules 1000 mg twice daily, clarithromycin sustained release tablets 500 mg twice daily. Patients will be instructed to take esomeprazole half an hour before meals, while amoxicillin and clarithromycin to be taken half an hour after meals. 
Intervention  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 three times daily. Patients will be instructed to take vonoprazan, amoxicillin 30 minutes after meals 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
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.  proportion of H. pylori negative patients in specific groups at least 4 weeks after treatment completion 
 
Secondary Outcome  
Outcome  TimePoints 
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 eradication  At least 4 weeks after treatment completion 
 
Target Sample Size   Total Sample Size="530"
Sample Size from India="530" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/04/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Helicobacter pylori is a gram-negative microaerophilic bacterium that colonizes the human stomach and remains highly prevalent worldwide. Although the global prevalence has declined in recent decades, H. pylori infection continues to be a major public health problem and is associated with peptic ulcer disease, chronic gastritis, and progression to gastric cancer. Successful eradication of the infection can reduce gastric mucosal damage and lower the risk of gastric malignancy.

Currently recommended eradication regimens include clarithromycin-based triple therapy and bismuth-containing quadruple therapy. However, these regimens are increasingly limited by rising antibiotic resistance, particularly to clarithromycin, metronidazole, and levofloxacin, as well as issues related to multiple drug combinations, increased adverse effects, and poor patient compliance.

High-dose amoxicillin dual therapy combined with potent acid suppression has emerged as a promising alternative approach. Recently, Vonoprazan, a potassium-competitive acid blocker, has shown stronger and more sustained acid inhibition compared with traditional proton pump inhibitors such as Esomeprazole. This may improve the efficacy of amoxicillin-based dual therapy.

However, evidence comparing vonoprazan-based high-dose dual therapy with standard proton pump inhibitor-based triple therapy in the Indian population is limited. Therefore, this randomized controlled trial aims to evaluate the safety and efficacy of these treatment regimens for H. pylori eradication in Eastern India.

 
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