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CTRI Number  CTRI/2025/12/099408 [Registered on: 18/12/2025] Trial Registered Prospectively
Last Modified On: 14/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study comparing two Vonoprazan-based treatments to treat H. pylori infection. 
Scientific Title of Study   A comparative study of Vonoprazan-based Hybrid therapy Vs Vonoprazan-based Dual Therapy as First line treatment for H. pylori: A open label, non-inferiority randomized controlled 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 Kishor H  
Designation  Senior Resident  
Affiliation  PES University Institute of Medical Sciences and Research 
Address  1st Floor, Roon no 11, Departement of General Medicine PES University Institute of Medical Sciences and Research PES University EC Campus, Hosur Road, Konappana Agarhara, Electronic City, Bangalore

Bangalore
KARNATAKA
560100
India 
Phone  8105580555  
Fax    
Email  kishoredurgan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manjari Sharma 
Designation  Assistant Professor  
Affiliation  PESU Institute Of Pharmacy 
Address  4th Floor, Room no 01 Faculty room, Pixel Block PESU Institute Of Pharmacy PES University EC Campus,Hosur Road, Konappana Agarhara Electronic City, Bangalore

Bangalore
KARNATAKA
560100
India 
Phone  9581633991  
Fax    
Email  manjarisharma@pes.edu  
 
Details of Contact Person
Public Query  
Name  Dr Manjari Sharma 
Designation  Assistant Professor  
Affiliation  PESU Institute Of Pharmacy 
Address  4th Floor, Room no 01 Faculty room, Pixel Block PESU Institute Of Pharmacy PES University EC Campus,Hosur Road, Konappana Agarhara Electronic City, Bangalore

Bangalore
KARNATAKA
560100
India 
Phone  9581633991  
Fax    
Email  manjarisharma@pes.edu  
 
Source of Monetary or Material Support  
PES University Institute of Medical Sciences and Research, PES University, EC Campus, Hosur Road, Konappana Agarhara, Electronic City, Bangalore, India. 560100 
 
Primary Sponsor  
Name  Dr Kishor H  
Address  1st Floor, Room no11 Department of General Medicine PES University Institute of Medical Sciences and Research PES University EC Campus, Hosur Road, Konappana Agarhara Electronic City, Bangalore 560100 
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 Kishor H  PES University Institute of Medical Sciences and Research.  1st Floor, Room 11, Department of General Medicine PES University Institute of Medical Sciences and Research PES University EC Campus, Hosur Road, Konappana Agarhara Electronic City, Bangalore 560100
Bangalore
KARNATAKA 		 8105580555

kishoredurgan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PES University Institute of Medical Sciences and Research.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B998||Other infectious disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Vonoprazan; Amoxicillin.  20 mg, BD, orally, 14 days; 500 mg, TID, orally, 14 days. 
Intervention  Vonoprazan; Amoxicillin; Metronidazole.  20 mg, BD, orally, 14 days; 500 mg, TID, orally, 14 days; 400 mg, BD, orally, from day 8-14. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Age above 18 years.
1.Treatment-naïve H. pylori infection confirmed by:
Endoscopy or Stool antigen test positive.
2.Willing and able to attend day 14 and Week 6 visit.  
 
ExclusionCriteria 
Details  1.Patient received prior H. pylori eradication therapy.
2.Patient with known allergies to Penicillins, Metronidazole, or Vonoprazan.
3.Pregnant and Lactating women.
4.Any Active upper GI bleeding, perforated Ulcer, or histologically confirmed
gastric malignancy (Past records).
5.Patients on Immunosuppressive therapy.
6.Patients of any prior gastric surgery.
7.Patients with known or suspected gastric malignancy.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Determination of H. pylori eradication at week 6 post treatment, by a stool
antigen test.  		 week 6  
 
Secondary Outcome  
Outcome  TimePoints 
Determination of the incidence and severity of adverse events (AEs) during
treatment, graded by CTCAE v5.0.  		 day 7, day 14, week 6 
Determination of change in GI symptom from baseline using the Gastrointestinal
symptom rating scale (GSRS) at Day 14 and week 6.  		 day 7, day 14, week 6 
Determination patient adherence measured by using pill count method.   day 7, day 14, week 6 
Assessing Health-related quality of life (EQ-5D-5L) at baseline and Week 6.   day 7, day 14, week 6 
Cost-per-eradication analysis including drug costs and adverse event
management costs.  		 day 7, day 14, week 6 
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
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)   29/01/2026 
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)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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   A Comparative study of Vonoprazan-based Hybrid therapy Vs Vonoprazan-based Dual therapy as First Line treatment for H. pylori: An Open-label, Non-inferiority randomized controlled trial. The primary outcomes is to Compare H. pylori eradication rate at week 6 post-therapy between Vonoprazan-based Hybrid therapy and Vonoprazan-based Dual therapy, the secondary outcomes  are determination of  the incidence and severity of Adverse event using the common terminology criteria for adverse events (CTCAE) version 5.0, and GI symptoms changes via Gastrointestinal symptom rating scale (GSRS) at Baseline, Day 14, Week 6, and to evaluate the patient adherence (Pill count, diaries etc., and to perform cost-eradication analysis which include drug cost and adverse event management expenses. This study is conducted for  a duration of 1 year. This study gives a better cost-effectiveness considering drug use and other healthcare cost, and lays foundation for generation of Indian-specific clinical evidence to guide future H. pylori treatment protocol and support rational antibiotic use. 
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