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CTRI Number  CTRI/2024/09/074495 [Registered on: 27/09/2024] Trial Registered Prospectively
Last Modified On: 26/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Comparison of Vonoprazan based therapy vs Standard Quadruple therapy for eradication of Helicobacter pylori. 
Scientific Title of Study   Comparison of Vonoprazan based therapy vs Standard Quadruple therapy for eradication of Helicobacter pylori 
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 Mohinish Chhabra 
Designation  Director Department of Gastroenterology 
Affiliation  Fortis hospital, Mohali 
Address  Room no. 127, Department of Gastroenterology Fortis Hospital Sector 62 Mohali
Room no. 127, Department of Gastroenterology Fortis Hospital Sector 62 Mohali
Rupnagar
PUNJAB
160062
India 
Phone  9814057593  
Fax    
Email  Chhabramohinish@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ankush Bansal 
Designation  Senior Resident 
Affiliation  Fortis Hospital,Mohali 
Address  Room no. 127, Department of Gastroenterology Fortis Hospital Sector 62 Mohali
Room no. 127, Department of Gastroenterology Fortis Hospital Sector 62 Mohali
Rupnagar
PUNJAB
160062
India 
Phone  9988381946  
Fax    
Email  ankushbansalab19@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ankush Bansal 
Designation  Senior Resident 
Affiliation  Fortis hospital, Mohali 
Address  Room no. 127, Department of Gastroenterology Fortis Hospital Sector 62 Mohali
Room no. 127, Department of Gastroenterology Fortis Hospital Sector 62 Mohali
Rupnagar
PUNJAB
160062
India 
Phone  9988381946  
Fax    
Email  ankushbansalab19@yahoo.com  
 
Source of Monetary or Material Support  
department of gastroenterology , fortis hospital, sector 62, mohali 
 
Primary Sponsor  
Name  NBE 
Address  National Board of Examinations, Dwarka sector 9 Rd,PSP area, New Delhi,India Pin code 110075 
Type of Sponsor  Research institution and hospital 
 
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 Ankush Bansal  fortis hospital  Room no. 127, Department of Gastroenterology Fortis Hospital Sector 62 Mohali
Rupnagar
PUNJAB 
9988381946

ankushbansalab19@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K296||Other gastritis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients aged 18-80 years
2. All symptomatic patients with dyspepsia (ROME criteria 4)with proven h pylori on biopsy/
urea breath test/stool for h pylori

ROME 4 CRITERIA

1. One or more of the following:

1. Bothersome postprandial fullness
2. Bothersome early satiation
3. Bothersome epigastric pain
4. Bothersome epigastric burning
AND
2. No evidence of structural disease (including at upper endoscopy) that is likely to explain the symptoms
(Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis)
 
 
ExclusionCriteria 
Details  Patients with the following findings will be excluded from the study
1. H/o gastric surgery such as partial gastrectomy
2. H/o allergy of drugs used in the study
3. Pregnant and lactating females
4. Alcohol or drug addiction
5. Lack of informed consent



 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Comparison of eradication rate of H. Pylori between the two regimens.  2 WEEKS 
 
Secondary Outcome  
Outcome  TimePoints 
none  none 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   07/10/2024 
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)   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  

Helicobacter pylori (H. pylori) infection is a general condition that is usually lifelong, with a prevalence reaching approximately 50% worldwide; in China, the prevalence has recently reached 44%. In December 2021, th.e U.S. Department of Health and Human Services listed chronic H. pylori as a clear carcinogen in the 15th report on carcinogens. It has also been proven to be closely related to multiple gastrointestinal (GI) diseases such as gastric adenocarcinoma, peptic ulcer (gastric and duodenal ulcer), chronic gastritis, and mucosa-associated lymphoid tissue (MALT) lymphoma. Successful H. pylori eradication would not only benefit individuals by improving histologic gastritis, preventing gastric carcinogenesis, and reducing the risk of serious complications but also block transmission and alleviate future medical expenses. However, H. pylori eradication rates have been decreasing in recent years, while the antibiotic resistance rate continues to increase.

Hence vonoprazan a novel potassium channel blocker, may be effective as a component of H. pylori eradication therapy. Vonoprazan therapy is approved for H pylori eradication and is currently being used in practice. We at our centre prescribe both the regimens. Patients will be prescribed treatment for 14 days. Confirmation of H. Pylori eradication will be done by stool H pylori antigen test or urea breadth test at 4 weeks at the end of h pylori treatment. Data of the patients taking quadruple therapy and vonoprazan therapy will be collected. Then H.Pylori eradication rate of  both the regimens will be calculated and then will be compared

 
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