| CTRI Number |
CTRI/2026/03/105993 [Registered on: 12/03/2026] Trial Registered Prospectively |
| Last Modified On: |
11/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Study to Evaluate Whether Treating Helicobacter pylori Improves Symptoms in Patients with Functional Dyspepsia Using two different Helicobacter pylori regimen on the basis of Acid-Reducing medicine compared to standard symptomatic treatment in Eastern India |
|
Scientific Title of Study
|
Role of Helicobacter pylori Eradication in Patients with Functional Dyspepsia Using Proton Pump Inhibitor and Potassium Competitive Acid Blocker Based Regimens in Eastern India: A Single Centre 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 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. |
|
|
Primary Sponsor
|
| Name |
Dr Sanjib Kumar Kar |
| Address |
Room No 209, Department Of Gastroenterology, Endoscopy Division,Service Road NH 16 Unit27 Gandarpur,sikharpur,Cuttack. |
| Type of Sponsor |
Other [SELF] |
|
|
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 Sanjib Kumar Kar |
Indian Institute Of Gastroenterology And Hepatology |
Room No 209, Department Of Gastroenterology, Endoscopy Division,Service Road NH 16 Unit27 Gandarpur,sikharpur,Cuttack
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K30||Functional dyspepsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Potassium Competitive Acid Blocker(PCAB) Group |
will receive PKAB based H Pylori eradication regime in the form of 14 days of clarithromycin 500 mg twice a day, amoxicillin 1000 mg twice a day, and vonoprazan 20 mg twice a day followed by 6 more weeks of vonoprazan 20mg once daily. |
| Intervention |
Proton Pump Inhibitor(PPI) Group |
will receive PPI based H Pylori eradication regime in the form of 14 days of clarithromycin 500 mg twice a day, amoxicillin 1000 mg twice a day, and Esomeprazole 40 mg twice a day followed by 6 more weeks of Esomeprazole 40mg once daily. |
| Comparator Agent |
Standard Medical Treatment(SMT)Group |
will receive only supportive care eg pain killer, antidepressant or only PPI (but no defined H Pylori eradication regime). They may receive the standard of care treatment for FD. Prokinetics before meals (levosulpiride 25 mg, acotiamide 100 mg, itopride 50 mg, cintapride 1mg) as and when required for PDS. They may receive PPI (Esomeprazole 40 mg or equivalent) for 8 weeks and/or prokinetics before meals (levosulpiride 25 mg, acotiamide 100 mg, itopride 50 mg) when required in patients with PDS. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Consecutive adult ( more than and equal to 18 years age) patients with Functional Dyspepsia(ROME IV criteria) with H. pylori positive by either Rapid urease test or Urea breath test will be included in the study. |
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating females
2. Children and adolescents (age lessthan18 years )
3. Those with predominant symptoms of heartburn, irritable bowel syndrome, history of peptic ulcer, upper gastrointestinal (GI) tract surgery, biliary colic and allergies to study medication
4. Those with esophagitis, peptic ulcer, polyp, or mass lesion
5. Those who have received previous eradication therapy for H. pylori
6. Those who have received antibiotics or bismuth during last 4 weeks prior to enrolment, proton pump inhibitors (PPI) or Potassium Competitive Acid Blocker(PCAB) in last 2 weeks prior to enrolment, or histamine-2 receptor blockers 1 week prior to enrolment
7. Those on drugs which have interactions with anti-H. pylori drugs
8. Those unable to answer the study questionnaires
9. Those with uncontrolled diabetes mellitus (HbA1c more than 9 ) and uncontrolled thyroid status (thyroid-stimulating hormone (TSH) more than 10 mIU per litre or less than 0.5mIU per litre)
10. Those not willing to give written consent
|
|
|
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 |
| Comparison of treatment success rate between Proton Pump Inhibitor group, Potassium Competitive Acid Blocker group and Standard Medical Treatment group. Treatment success is defined as absence of symptoms or minimal symptoms with reduction of Short Form Leeds Dyspepsia Questionnaire score by at least four to five points from the total score or at least thirty percent reduction from baseline. |
Eight weeks after completion of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of Helicobacter pylori eradication rate between Proton Pump Inhibitor based regimen group and Potassium Competitive Acid Blocker based regimen group. Eradication is defined as negative rapid urease test or negative urea breath test. |
Two weeks after completion of treatment. |
|
|
Target Sample Size
|
Total Sample Size="552"
Sample Size from India="552"
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
|
Brief Summary (for Clinical Trials Registry of India CTRI): Functional dyspepsia is common in India, affecting nearly thirty percent of adults. It is characterized by postprandial fullness, early satiation, epigastric pain, or epigastric burning without any identifiable organic cause on routine evaluation. The role of Helicobacter pylori infection in causing symptoms of functional dyspepsia remains controversial. Some studies and meta analyses have shown improvement in symptoms after eradication therapy, while others have shown little or no benefit. Because of these conflicting findings and limited data from India, the benefit of eradication therapy in patients with functional dyspepsia is still uncertain. This study aims to evaluate whether eradication of Helicobacter pylori provides additional symptomatic benefit compared with standard medical treatment in patients with Helicobacter pylori positive functional dyspepsia. In this prospective randomized controlled trial, patients will receive either Proton Pump Inhibitor based eradication therapy, Potassium Competitive Acid Blocker based eradication therapy, or standard medical treatment. The study will compare improvement in dyspeptic symptoms and eradication rates among the treatment groups. The results may help clarify the role of Helicobacter pylori eradication in the management of functional dyspepsia in the Indian population. |