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CTRI Number  CTRI/2026/02/102951 [Registered on: 04/02/2026] Trial Registered Prospectively
Last Modified On: 02/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study on causes and symptoms of indigestion in patients 
Scientific Title of Study   TO STUDY CLINICO-ETIOLOGICAL PROFILE OF PATIENTS PRESENTING WITH DYSPEPTIC FEATURES 
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 AVTAR SINGH DHANJU  
Designation  PROFESSOR  
Affiliation  SGRDIMSR 
Address  House number 306 GREENFIELD AVENUE MAJITHA ROAD AMRITSAR AMRITSAR PUNJAB

Amritsar
PUNJAB
143001
India 
Phone  7009067238  
Fax    
Email  avtar.dhanju.ad@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR AVTAR SINGH DHANJU  
Designation  PROFESSOR  
Affiliation  SGRDIMSR 
Address  House number 306 GREENFIELD AVENUE MAJITHA ROAD AMRITSAR AMRITSAR PUNJAB

Amritsar
PUNJAB
143001
India 
Phone  7009067238  
Fax    
Email  avtar.dhanju.ad@gmail.com  
 
Details of Contact Person
Public Query
 
Name  SHWETA SANDHU 
Designation  JUNIOR RESIDENT 
Affiliation  SGRDIMSR 
Address  Sri Guru Ram Das Institute of Medical Sciences, Amritsar,Punjab,143501,India

Amritsar
PUNJAB
143501
India 
Phone  9855043133  
Fax    
Email  sandhushweta98@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Department of medicine  
Address  SGRDIMSR , VALLAH, AMRITSAR 
Type of Sponsor  Private medical college 
 
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 shweta  Sri guru ram Das institute of medical sciences and research  Department of medicine , 3rd floor , Amritsar , Punjab
Amritsar
PUNJAB 
9855043133

sandhushweta98@gmail.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: K219||Gastro-esophageal reflux disease without esophagitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Age more than 18 years, OPD and IPD patients.

Upper abdominal symptoms example epigastric pain, bloating, nausea, early satiety.

Willingness to undergo diagnostic evaluation like endoscopy, imaging, USG whole abdomen , routine tests like CBC, RFT, LFT, ELECTROLYTES, HBA1C , and amylase, lipase. 
 
ExclusionCriteria 
Details  1. Prior gastric surgery


2. Comorbidities like liver failure, uncontrolled diabetes


3. Pregnancy or lactation


4. H/o substance abuse.


5. Critically ill patients 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the underlying etiologies responsible for dyspeptic features based on clinical assessment and investigations and categorize dyspepsia into organic and functional causes among study population  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Nil   
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   14/02/2026 
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="6"
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  
Dyspepsia is a common gastrointestinal symptom complex characterized by chronic or recurrent upper abdominal discomfort, including epigastric pain, postprandial fullness, early satiety, bloating, nausea, and heartburn. It represents a significant clinical burden due to its high prevalence and impact on quality of life. Dyspepsia may be broadly classified into organic dyspepsia, where an identifiable structural or biochemical cause is present, and functional (non-ulcer) dyspepsia, where no organic pathology is detected on routine investigations, including upper gastrointestinal endoscopy.

This observational cross-sectional study aims to evaluate the clinico-etiological profile of adult patients presenting with dyspeptic features and to categorize them into organic and functional dyspepsia based on clinical assessment and investigative findings. The study will be conducted in the Department of Medicine at Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar, over a period from September 2025 to February 2027.

A total of 100 patients aged 18 years and above presenting with dyspeptic symptoms will be enrolled. All participants will undergo detailed clinical evaluation, relevant laboratory investigations, ultrasonography of the abdomen, and upper gastrointestinal endoscopy. Based on endoscopic findings, patients will be classified into organic or functional dyspepsia groups. The diagnostic yield of endoscopy and the distribution of etiological factors will be analyzed.

The findings of this study are expected to enhance understanding of the clinical patterns and etiologies of dyspepsia, assist in rational use of diagnostic endoscopy, and support more targeted and cost-effective management strategies, particularly in resource-limited settings.
 
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