| 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
|
|
|
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
|
|
|
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. |