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: 1)Participants in age group 25 to 60 years Previously diagnosed cases of MASLD Presence of excess triglyceride storage in the liver confirmed by imaging and presence of at least one cardiometabolic risk factor i.e. (1)BMI equal or more than 24 kg/m2 OR WC greater than 94 cm (M) 80 cm (F) defined as BMI subgroup (2) Fasting serum glucose greater than or equal to 125 mg/dL ( greater than or equal to 5.6 mmol/L) or 2 hour post load glucose level greater than or equal to 199 mg/dL (greater than or equal to 7.8 mmol/L) or HbA1c greater than or equal to 6.2% OR diagnosis of DM OR treatment for DM defined as DM subgroup (3) Blood pressure greater than or equal to 130/85 mmHg OR specific antihypertension treatment defined as HT subgroup (4) Plasma triglycerides greater than or equal to 1.70 mmol/L (greater than or equal to 150mg/dl) OR lipid lowering treatment defined as TG subgroup (5) Plasma HDL less than 1mmol/L (less than 40 mg/dl) (Male) and less than 1.3 mmol/L (less than 50 mg/dl) (Female) OR lipid lowering treatment defined as HDL subgroup 2)Participants having FIB 4 score less than 3.4 and METAVIR score less than or equal to F2
Exclusion criteria
Exclusion criteria: 1) Patients of Fatty liver without having a minimum of one cardio metabolic risk factors. 2) Patients with uncontrolled DM (FBS greater than 200mg/dl) stage II HTN (160/100 mm Hg) overt hypothyroidism (TSH 10 Miu/L) even on taking medications. 3) Patients suffering from AIDS Tuberculosis other infectious diseases Malignancies Major psychiatric problems or any other serious illness. 4) Patients suffering from fatty liver grade III, Hepatitis Cirrhosis of the Liver hepatocellular carcinoma ascites chronic kidney disease and other associated gall bladder diseases such as cholecystitis and cholelithiasis. 5) Patient on long-term medications (Hepatotoxic medications like NSAID Rifampicin Steroid). 6) Patient taking medications known to induce fatty liver (such as steroids amiodarone methotrexate tamoxifen valproic acid or herbal/dietary supplements affecting liver function within the previous 6 months). 7) Patient who has severe cardiac pulmonary or underlying conditions (such as congestive heart failure ischemic heart disease third-degree atrioventricular block or chronic obstructive pulmonary disease). 8) Patient consuming alcohol or other narcotic substances. 9) Patient not willing to participate in the clinical trial. 10) Pregnant/breastfeeding female at screening or throughout the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in lipid profile. (Mean change of triglyceride, high-density cholesterol, low-density cholesterol from baseline in 90 days)Timepoint: 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in hepatic steatosis. (METAVIR score and FIB-4 score (qualitative measurement with USG & Fibroscan) from baseline to 90 days) 2. Changes in body weight, waist circumference, and BMI. (Mean change from baseline in 90 days) 3. Reduction in the Liver enzymes. (Mean change of AST, ALT, Total bili. and alkaline phosphatase from baseline in 90 days) 4. Changes in systolic blood pressure, and diastolic blood pressure. (Mean change from baseline in 90 days) 5. Changes in blood glucose levels. (Mean change from baseline in 90 days). 6. To improve the quality of life of patients having MASLD assessed by CLDQ (chronic liver disease questionnaire). (Mean change from baseline in 90 days). 7. Improvement in overall symptoms of fatty liver. (in the case of symptomatic patients it can be considered)Timepoint: 90 days | — |
Countries
India
Contacts
Public ContactApurva Ketkar
Institute of Teaching and Research in Ayurveda Jamnagar
Outcome results
None listed