| 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
|
|
|
Primary Sponsor
|
| Name |
Department of medicine |
| Address |
SGRDIMSR , VALLAH, AMRITSAR |
| Type of Sponsor |
Private medical college |
|
|
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 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
|
|
|
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
|
|
|
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. |