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CTRI Number  CTRI/2026/03/107019 [Registered on: 30/03/2026] Trial Registered Prospectively
Last Modified On: 25/03/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Testing How Reliable Ultrasound Measurement is for Screening Liver Fat in Healthy Young Adults. 
Scientific Title of Study   Reproducibility And Reference Range Of The Hepato-Renal Echogenicity Index In Healthy Young Adults: A Quantitative Ultrasound Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manojkumar A  
Designation  Post Graduate Resident  
Affiliation  Navodaya Medical College Hospital And Research Centre 
Address  Dr Manojkumar A Post Graduate Resident Department of Radio Diagnosis Navodaya Medical College Hospital And Research Centre Raichur-584103

Raichur
KARNATAKA
584103
India 
Phone  7899946321  
Fax    
Email  manojkumar.rd@navodaya.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manojkumar A  
Designation  Post Graduate Resident  
Affiliation  Navodaya Medical College Hospital And Research Centre  
Address  Dr Manojkumar A Post Graduate Resident Department of Radio Diagnosis Navodaya Medical College Hospital And Research Centre Raichur-584103

Raichur
KARNATAKA
584103
India 
Phone  7899946321  
Fax    
Email  manojkumar.rd@navodaya.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr. M Bharathi 
Designation  Professor and HOD 
Affiliation  Navodaya Medical College Hospital And Research Centre  
Address  Dr. M Bharathi Department of Radio Diagnosis Navodaya Medical College Hospital And Research Centre Raichur-584103

Raichur
KARNATAKA
584103
India 
Phone  9880639388  
Fax    
Email  drmbharathi.rad.nmc@navodaya.edu.in  
 
Source of Monetary or Material Support  
No monetory support Material support: Use of department ultrasound machines for research, Department of Radio Diagnosis, Navodaya Medical College Hospital And Research Centre.Raichur, karnataka , India -584103  
 
Primary Sponsor  
Name  Dr Manojkumar A  
Address  Department of Radio Diagnosis Navodaya Medical College Hospital And Research Centre Raichur-584103 
Type of Sponsor  Other [Individual] 
 
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 Manojkumar A   Navodaya Medical College Hospital And Research Centre   Department of Radio Diagnosis, Room no 13,Ground floor.
Raichur
KARNATAKA 
7899946321

manojkumar.rd@navodaya.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committeee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Measurement of Hepato-Renal Echogenicity index for Hepatic Steatosis screening  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1)Age between 18 and 30 years.
2)Healthy volunteers with no known chronic illness.
3)Willingness to provide informed written consent. 
 
ExclusionCriteria 
Details  1)Known history of chronic liver disease, renal disease, or Diabetes Mellitus.
2)BMI more than or equal to 30 kg/m2 (Exclusion of overt obesity, which is a key risk factor for steatosis).
3)History of heavy alcohol consumption, pregnancy, or consumption of a large, high-fat meal within 2 hours of the scan. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Inter-observer Reliability of Hepato-Renal Index (HRI)  At the time of image analysis 
 
Secondary Outcome  
Outcome  TimePoints 
Establishment of Normal Reference range & Correlation with BMI  4 weeks following completion of data collection for 70 subjects. 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   07/04/2026 
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="0"
Months="8"
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  
Title: Testing How Reliable Ultrasound Measurement is for Screening Liver Fat in Healthy Young Adults.
Why We Are Doing This Study
Currently, doctors often look at ultrasound pictures to guess if a patient has too much fat in their liver (steatosis). This method is like judging a picture—it’s subjective, meaning the results often change depending on which doctor performs the scan. This lack of agreement can lead to missed diagnoses of early liver problems.
We are testing a new, objective way to screen the liver: using the ultrasound machine to take an exact numerical measurement of the liver’s brightness, instead of just looking at it.
How the Study Works
Who is Participating: We are enrolling 70 healthy young adults (age 18–30) who are not severely overweight.
The Procedure: Each volunteer receives a simple, standard ultrasound scan of the abdomen while lying down. Crucially, the scan is done when the volunteer is not fasting.
The Test: Two different trained doctors will independently take the same measurement. We then use computer software to see how closely their numerical results match.
What We Hope to Find
Primary Goal (Reliability):
To check how consistent and reliable the new objective liver measurement is when taken by two different doctors. This proves the tool can be used widely without errors caused by the operator.
Secondary Goal (Normal Threshold):
To establish the normal, healthy range for this liver measurement in our population. 
This provides doctors with a reliable cutoff score—a "red flag" number—for quickly identifying patients who might have a problem and need further investigation.
This study will provide doctors with a scientifically validated, easy-to-use, and objective score for early liver health screening.
 
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