| CTRI Number |
CTRI/2025/02/080551 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
31/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
This study is all about figuring out how many people in the area are at risk for Non Alcoholic Fatty Liver Disaese and whether they know about Non Alcoholic Fatty Liver Disaese. |
|
Scientific Title of Study
|
Awareness and risk factors of Non Alcoholic Fatty Liver Disease (NAFLD) among patients of selected tertiary care hospital of Udupi district, Karnataka: A case –control study |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RACHEL R |
| Designation |
Msc Nursing student |
| Affiliation |
Manipal college of Nursing, Manipal Academy of Higher Education |
| Address |
Department of Medical Surgical Nursing 5th floor Manipal college of Nursing Manipal Academy of Higher Education Manipal Udupi Karnataka India.
Udupi
KARNATAKA
576104
India |
| Phone |
7708794900 |
| Fax |
|
| Email |
rachelctri97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Daisy J Lobo |
| Designation |
Associate Professor |
| Affiliation |
Manipal college of Nursing, Manipal Academy of Higher Education |
| Address |
Department of Medical Surgical Nursing, Manipal college of Nursing, Manipal Academy of Higher Education, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9535687697 |
| Fax |
|
| Email |
Daisy.j@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Daisy J Lobo |
| Designation |
Associate Professor |
| Affiliation |
Manipal college of Nursing, Manipal Academy of Higher Education |
| Address |
Department of Medical Surgical Nursing, Manipal college of Nursing, Manipal Academy of Higher Education, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9535687697 |
| Fax |
|
| Email |
Daisy.j@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Medicine and Surgery, Kasturba Hospital Manipal Academy of Higher Education, MAHE, Manipal, Udupi ,Karnataka -576104 |
|
|
Primary Sponsor
|
| Name |
Rachel R |
| Address |
2nd year MSc Nursing student Department of Medical Surgical Nursing, Manipal college of Nursing, Manipal Academy of Higher Education, Manipal, Karnataka,
India-576104 |
| Type of Sponsor |
Other [Self] |
|
|
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 Daisy J lobo |
Kasturba Hospital |
Department of Medicine and Surgery 3rd floor, Kasturba Hospital Manipal Academy of Higher Education Manipal Karnataka 576104
Udupi
KARNATAKA |
9535687697
Daisy.j@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
Nil |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Cases
1. Diagnosed patients with non-alcoholic fatty liver using ultrasonography.
2. The patient’s age above 18 years
Controls
1. Patients without non-alcoholic fatty liver in the ultrasonography.
2. The patient’s age above 18 years |
|
| ExclusionCriteria |
| Details |
Cases
1. The patients with alcoholic fatty liver.
2. The children below 18 years of age.
3. The patients’ diagnosis with hepatitis B and hepatitis C infections.
Control
1. The patients diagnosed with fatty liver disease
2. The patients with any other liver related issues.
3. The patients with age below 18 years. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
At the end of the study the outcome measures are the awareness and the
risk factors of Non alcoholic fatty liver disease (NAFLD) among patients of tertiary care hospital. |
4 weeks |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="345"
Sample Size from India="345"
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)
|
11/02/2026 |
| 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="0"
Months="6"
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
|
The data collection for the study will be done only after the approval from CTRI. The tentative data collection for the study is targeted from 2nd February 2025 to 9th March 2025 in the spend of one month. The participant will be recruited only after participant consenting the consent form. |