Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Fatty liver Grade one and Grade two with Any One of the following Criteria. Body Mass Index greater or equal to 23 in Asian. Diagnosed patient of type 2 Diabetes. Or Fatty liver Grade one and Grade two detected by Ultrasound, blood biomarkers with Any two of the following risk factors. Waist circumference greater than or equal to 90 and 80 cm in Asian men and women respectively. Blood pressure greater or equal 130 upon 85 mmHg or specific drug treatment. HDL level less or equal to 40 mg/dl in males, less or equal to 50 mg/dl in females or specific drug treatment. Triglycerides greater or equal to 150 mg/dl or specific drug treatment. Prediabetes that is FBS 100 to 125 mg/dl. Homeostasis model assessment of insulin resistance score greater or equal to 2.5. Plasma high-sensitivity C-reactive protein level greater than 2 mg/L. Age between 18 to 60 years of either gender. Patient willing to participate and follow the protocol.
Exclusion criteria
Exclusion criteria: Hepatic steatosis in adults less than 5%. Patients with uncontrolled type 2 Diabetes. (FBS greater or equal to 250mg/dl, PPBS greater than 350mg/dl or HbA1c greater or equal to 10%). Patients with uncontrolled Hypertension greater or equal to160 upon 100 mmHg). Patients with uncontrolled lipid profile Total cholesterol greater than 250 mg/dl, Triglycerides greater than 499 mg/dl, LDL greater than 189 mg/dl, HDL greater than 70 mg/dl. Patients suffering from severe cases of liver disease Serum Bilirubin greater than 10mg/dL, AST and ALT greater than 400U/L. Patients suffering from chronic liver disease and cancer. Severe cases of heart, kidney, lung, or other systemic diseases. Pregnant or lactating female.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of Liver Steatosis Grade and improvement in the Serum concentration of Liver Enzymes. Timepoint: 56 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of subjective Parameters (Indigestion, Fatigue, Right upper quadrant discomfort, Hepatomegaly) Assessment of Quality-of-Life, World Health Organization Quality of Life Questionnaire (WHOQOL-BREF). Anthropometric indices: Body weight, Waist Circumference, BMI. Glycemic indices: FBS, PPBS, HbA1c. Lipid Profile: TG, TC, HDL, and LDL. Blood Pressure; SBP and DBP. Timepoint: 56 days | — |
Countries
India
Contacts
National Institute Of Unani Medicine