Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
None listed
Sponsors
Institute of Teaching and Research in Ayurveda, Jamnagar
Eligibility
Inclusion criteria
Inclusion criteria: Patients diagnosed with Grade I and Grade II MASLD on ultrasonography Previously diagnosed cases of MASLD with evidence of excess triglyceride storage in the liver confirmed by imaging and presence of at least one of the following cardiometabolic risk factors BMI greater than or equal to 24 kg/m OR waist circumference greater than 94 cm in males and greater than 80 cm in females Fasting serum glucose greater than or equal to 125 mg/dL or 2 hour post load glucose greater than or equal to 199 mg/dL or HbA1c greater than or equal to 6.2% or diagnosed diabetes mellitus or on antidiabetic treatment Blood pressure greater than or equal to 130/85 mmHg or on antihypertensive treatment defined as HT subgroup Plasma triglycerides greater than or equal to 150 mg/dL or on lipid lowering treatment Plasma HDL cholesterol less than 40 mg/dL in males and less than 50 mg/dL in females or on lipid lowering treatment Participants having FIB 4 score less than 3.4 and METAVIR score less than or equal to F2
Exclusion criteria
Exclusion criteria: Patients with uncontrolled DM with FBS greater than 200 mg/dL Stage II HTN with blood pressure 160/100 mmHg and overt hypothyroidism with TSH greater than 10 mIU/L even while on medications Patients diagnosed with Grade III MASLD on ultrasonography Patients suffering from AIDS Tuberculosis other infectious diseases malignancies major psychiatric disorders or any other serious illness Patients suffering from Hepatitis Cirrhosis of Liver hepatocellular carcinoma ascites chronic kidney disease and associated gall bladder diseases such as cholecystitis and cholelithiasis Patients on long term hepatotoxic medications such as NSAIDs Rifampicin and Steroids Patients taking medications known to induce fatty liver such as steroids amiodarone methotrexate tamoxifen valproic acid or herbal or dietary supplements affecting liver function within the previous 6 months Patients having severe cardiac pulmonary or other underlying conditions such as congestive heart failure ischemic heart disease third degree atrioventricular block or chronic obstructive pulmonary disease Patients consuming alcohol or other narcotic substances Patients not willing to participate in the clinical trial Pregnant or breastfeeding females at screening or throughout the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Liver Function test(LFT) parameters Change in Lipid profile parameters Improvement in Ultrasonographic grading of MASLDTimepoint: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Body Mass Index (BMI) Improvement in clinical sign and symptoms such as Agnimandya Gaurava and AlasyaTimepoint: 1 Year | — |
Countries
India
Contacts
Public ContactZankhana Garasiya
Institute of Teaching and Research in Ayurveda, Jamnagar
Outcome results
None listed