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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

Prospective, randomized, two-arm, interventional pilot study to evaluate accuracy of a digital platform that validates early risk and severity of Non-alcoholic Fatty Liver Disease (NAFLD) and disease management approach in Indian NAFLD patients - NA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/05/042359
Enrollment
100
Registered
2022-05-04
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified

Interventions

Intervention1: Lycopodium, Cardus marianus, Cinchona, Chelidonium, Carbo Veg, Calcarea Carb, Lapis alba, Phos, Acid Phos, Merc, Picric acid,Vanadium Met, Kali Bichromicum, Kali Carb, Lyssin, Bryonia A

Sponsors

IIT Bombay
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Evidence of severe or uncontrolled systemic diseases, active bleeding diathesis, or active infection including hepatitis B, hepatitis C, and HIV.

Design outcomes

Primary

MeasureTime frame
1. Benchmark and evaluate accuracy of a digital NAFLD management platform with disease severity prediction in the Indian population. 2. Evaluate the accuracy of the algorithm for early validation of NAFLD. Timepoint: 1. 0,3,6 months 2. 0,3,6 months—

Secondary

MeasureTime frame
Benchmark NAFLD disease management algorithm.Timepoint: 0, 6 months—

Countries

India

Contacts

Public ContactDr Kirti Mutreja

Bhaktivedanta Hospital and Research Institute

kirti.m@bhaktivedantahospital.com99310421121

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026