| 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
|
|
|
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
|
|
|
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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