Health Condition 1: E889- Metabolic disorder, unspecified
Conditions
Interventions
None listed
Sponsors
CCRAS
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosed cases of Grade- I&II of Non-alcoholic fatty liver disease as evident fatty infiltration on Ultrasound. Either sex aged between18- 60 years. Subjects of non-alcoholic fatty liver disease with their hepatic enzymes Willing to provide written consent and able to participate for 4 months in the study.
Exclusion criteria
Exclusion criteria: H/o habitual consumption of alcohol intake of >20g/day for women, >40g/day for men Any other identified cause of chronic liver disease The use of medication which would cause non-alcoholic fatty liver - disease e.g. tamoxifen Already taking supplementary medicine for NAFLD On anticoagulants (antiplatelet aggregators are permitted) Past history of Cardiac Arrhythmia, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months. Symptomatic patients with clinical evidence of congestive cardiac failure. Subjects with concurrent Renal Dysfunction (defined as S. creatinine > 1.2 mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease. Uncontrolled Diabetes Mellitus (HbA1C >8) Known cases of HIV and AIDS, malignancy, Hepatitis B Subjects participated in any other clinical trial. Women who are planning for conception / pregnant or lactating.Any other condition which the P.I. thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the change in fibroscan score (Kpa) and CAP value (Kpa) or MRI-PDFFTimepoint: Baseline& 90th day | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess changes in ALT, AST, Serum bilirubin, Total proteins & Alkaline Phosphatase Changes in Lipid profile Changes in HbA1C Change in BMI To measure change in Fatty Liver Index To assess any biological intolerability or adverse events during the trial period Timepoint: Baseline, 90th day | — |
Countries
India
Contacts
Public ContactDr Banamali Das
CCRAS
Outcome results
None listed