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CTRI Number  CTRI/2025/11/097362 [Registered on: 13/11/2025] Trial Registered Prospectively
Last Modified On: 10/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) 
Study Design  Other 
Public Title of Study
Modification(s)  
Comparison of different medicine combinations used to treat H pylori bacterial infection of the stomach 
Scientific Title of Study
Modification(s)  
Comparative Effectiveness And Safety Of Different PCAB Based Triple Therapy Regimens For Helicobacter Pylori Eradication 
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 Naresh Agarwal 
Designation  Senior Director of Gastroenterology And Therapeutic Endoscopy  
Affiliation  Max Super Speciality Hospital Patparganj (A Unit of Balaji Medical and Diagnostic Research Centre) 
Address  Max Super Speciality Hospital Patparganj (A Unit of Balaji Medical and Diagnostic Research Centre) 108A Indraprastha Extension Patparganj New Delhi 110092 India
108A Indraprastha Extension Patparganj New Delhi 110092 India
East
DELHI
110092
India 
Phone  9810612415  
Fax    
Email  nareshagarwal.na@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Naresh Agarwal 
Designation  Senior Director of Gastroenterology And Therapeutic Endoscopy  
Affiliation  Max Super Speciality Hospital Patparganj (A Unit of Balaji Medical and Diagnostic Research Centre) 
Address  Max Super Speciality Hospital Patparganj (A Unit of Balaji Medical and Diagnostic Research Centre) 108A Indraprastha Extension Patparganj New Delhi 110092 India
108A Indraprastha Extension Patparganj New Delhi 110092 India
East
DELHI
110092
India 
Phone  9810612415  
Fax    
Email  nareshagarwal.na@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Naresh Agarwal 
Designation  Senior Director of Gastroenterology And Therapeutic Endoscopy  
Affiliation  Max Super Speciality Hospital Patparganj (A Unit of Balaji Medical and Diagnostic Research Centre) 
Address  Max Super Speciality Hospital Patparganj (A Unit of Balaji Medical and Diagnostic Research Centre) 108A Indraprastha Extension Patparganj New Delhi 110092 India
108A Indraprastha Extension Patparganj New Delhi 110092 India
East
DELHI
110092
India 
Phone  9810612415  
Fax    
Email  nareshagarwal.na@gmail.com  
 
Source of Monetary or Material Support  
Max Super Speciality Hospital Patparganj (A Unit of Balaji Medical and Diagnostic Research Centre) 108 A Indraprastha Extension Patparganj New Delhi 110 092 India  
 
Primary Sponsor  
Name  Dr Naresh Agrawal 
Address  Max Super Speciality Hospital, Patparganj (A Unit of Balaji Medical and Diagnostic Research Centre) 108A IP Extension I P Extension Patparganj Delhi 110092 
Type of Sponsor  Private hospital/clinic 
 
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 Naresh Agarwal   Max Super Speciality Hospital Patparganj (A Unit of Balaji Medical and Diagnostic Research Centre)   108 A IP Extension Patparganj New Delhi 110092 room no. 2025 clinical research department
East
DELHI 
9810612415

nareshagarwal.na@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee   Approved 
Institutional Ethics Committee Max Super Speciality Hospital Patparganj A Unit of Balaji Medical and Diagnostic Research Centre   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K319||Disease of stomach and duodenum, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1 GroupA Vonoprazan Amoxicillin Clarithromycin 2 GroupB Vonoprazan Amoxicillin Levofloxacin 3 GroupC Fexuprazan Amoxicillin Clarithromycin   1 GroupA Vonoprazan 20mg twice a day Amoxicillin 1000mg twice a day Clarithromycin 500mg twice a day for 7 days 2 GroupB Vonoprazan 20 mg twice a day Amoxicillin 1000 mg twice a day Levofloxacin 500 mg once a day for 7 days 3 GroupC Fexuprazan 40 mg twice a day Amoxicillin 1000 mg twice a day Clarithromycin 500 mg once a day for 7 days Eligible participants will be randomly assigned in a 1111 ratio to one of the four treatment arms using a computer generated randomisation sequence prepared by an independent statistician using variable block sizes Randomisation details will be documented in a dedicated log and analysis will follow the intention to treat principle 
Comparator Agent  4 GroupD (Standard regimen) PPI Amoxicillin Clarithromycin   4 GroupD (Standard regimen) PPI 40mg twice in a day Amoxicillin 1000 mg twice a day Clarithromycin 500 mg twice a day for 14 days Eligible participants will be randomly assigned in a 1111 ratio to one of the four treatment arms using a computer generated randomisation sequence prepared by an independent statistician using variable block sizes Randomisation details will be documented in a dedicated log and analysis will follow the intention to treat principle 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Age 18 65 years
Confirmed H pylori infection by endoscopy rapid urease test (RUT) Urea breath test
 
 
ExclusionCriteria 
Details  Prior H pylori eradication therapy within 6 months
Allergy or intolerance to any study drugs
Antibiotic or PPI use within 4 weeks prior to enrolment
Pregnancy or lactation
Severe liver kidney or cardiovascular disease neurological or oncological disease
History of gastric surgery or malignancy
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
H Pylori eradication Rate ( UBT confirmed)   After completion of the drug administration phase weekly telephonic follow ups will be conducted for three consecutive weeks followed by an in person follow up visit at week four

After therapy
At Baseline
At week 1st telephonic
At week 2nd telephonic
At week 3rd telephonic
At week 4th In Person 
 
Secondary Outcome  
Outcome  TimePoints 
Major And Minor Adverse Events
Compliance And discontinuation rate  
After completion of the drug administration phase weekly telephonic follow ups will be conducted for three consecutive weeks followed by an in person follow up visit at week four 
 
Target Sample Size
Modification(s)  
Total Sample Size="300"
Sample Size from India="300" 
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   N/A 
Date of First Enrollment (India)   28/11/2025 
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="0"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 (H pylori) is a gram negative bacterium that colonizes the gastric mucosa and plays a central role in the pathogenesis of chronic gastritis peptic ulcer disease mucosa associated lymphoid tissue (MALT) lymphoma and gastric cancer Eradication of H pylori is critical not only for symptom relief but also for long term prevention of serious gastrointestinal complications
Traditional eradication regimens are based on proton pump inhibitor (PPI)based triple therapy which includes a PPI amoxicillin and clarithromycin However rising antibiotic resistance particularly to clarithromycin and metronidazole has reduced the efficacy of these standard therapies often dropping success rates below 80
To overcome these limitations newer agents like potassium competitive acid blockers (PCABs)notably vonoprazan have been introduced These provide stronger and more sustained acid suppression improving the gastric environment for antibiotic action Modified regimens such as vonoprazan based dual triple and quadruple therapies have demonstrated superior eradication rates particularly in resistant populations
The choice of eradication regimen depends on local antibiotic resistance patterns previous treatment history and patient specific factors such as allergies and tolerability Ongoing research is focused on optimizing treatment duration drug combinations and the use of novel acid suppressants like fexuprazan which remains under investigation

 
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