A pilot study to evaluate accuracy of a digital platform which validates early risk and severity of Non-alcoholic Fatty Liver Disease (NAFLD) and disease management approach in Indian NAFLD patients
Not Applicable
- Conditions
- Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
- Registration Number
- CTRI/2022/05/042359
- Lead Sponsor
- IIT Bombay
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Healthy individuals confirmed to be free from NAFLD by the doctor for the Control Group.
2. Patients with confirmed NAFLD as indicated in the Liver Profile Tests for the NAFLD Group
3. Subjects of age 18 to 60 years.
4. Gender -All
5. Ability to comply with study visits and provide informed consent.
6. Diagnostic data are available for algorithm validation.
7. Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
1. Evidence of severe or uncontrolled systemic diseases, active bleeding diathesis, or active infection including hepatitis B, hepatitis C, and HIV.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Benchmark and evaluate accuracy of a digital NAFLD management platform with disease severity prediction in the Indian population. <br/ ><br>2. Evaluate the accuracy of the algorithm for early validation of NAFLD. <br/ ><br> <br/ ><br>Timepoint: 1. 0,3,6 months <br/ ><br>2. 0,3,6 months
- Secondary Outcome Measures
Name Time Method Benchmark NAFLD disease management algorithm.Timepoint: 0, 6 months