Metabolic (dysfunction)-associated fatty liver disease (MAFLD)
Conditions
Interventions
Setting: The study will be conducted at the liver clinic of Colombo North Teaching Hospital, Ragama. The study will recruit consenting patients diagnosed with MAFLD who fulfill the specified inclusion
Sponsors
Research and Development center, Link Natural Products (Pvt.) Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Participants must meet all the following inclusion criteria to be eligible for enrollment into the study: 1.Both male and non-pregnant, non-lactating female patients aged 18 - 75 years who provide written informed consent before starting the study. 2.Who had undergone FibroScan within the 3 months of period showing a liver-stiffness measurement of 10-15 kPa. 3.MAFLD patients diagnosed based on following criteria: Ultrasonically proven of hepatic steatosis in conjunction with at least one of following criteria. a. Overweight/ obesity (BMI 23 kg/m2 in Asians) or WC > 90 cm (male) 80 cm (Female) b. Prediabetes: HbA1c 39-47 mmol/mol (5.7-6.4%) or fasting plasma glucose 5.6-6.9 mmol/L (100-125 mg/dl) or 2-h plasma glucose during OGTT 7.8-11 mmol/L (140-199 mg/dl) or Type 2 diabetes: HbA1c 48 mmol/mol (6.5%) or fasting plasma glucose 7.0 mmol/L (126 mg/dl) or 2-h plasma glucose during OGTT 11.1 mmol/L (200 mg/dl) or Treatment for type 2 diabetes. c. Plasma triglycerides 1.7 mmol/L (150 mg/dl) or lipid-lowering treatment. d. HDL-cholesterol 1.0 mmol/L (39 mg/dl) in men and 1.3 mmol/L (50 mg/dl) in women or lipid-lowering treatment. e. Blood pressure 130/85 mmHg or treatment for hypertension. 4.Participants should have been on a stable dose of anti-diabetic medication and hypolipidemic drugs if they are taking any for at least 3 months prior to entry. 5.Participants who are not on any medical treatment or herbal supplements for NAFLD/MAFLD.
Exclusion criteria
Exclusion criteria: 1.Those with a history of significant alcohol consumption. (more than 20 g/day for women and 30g/day for men ? 2 units alcohol/day for women and >3 units for men). 2.Volunteers with known other potential causes of liver disease other than NAFLD/MAFLD including Hepatitis B, Hepatitis C, Dengue hepatitis, chronic viral hepatitis, autoimmune and hereditary liver disease. 3.Continued use of drugs historically associated with NAFLD/MAFLD (amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens at doses greater than those used for hormone replacement, anabolic steroids, valproic acid, and other known hepatotoxins) for more than 2 weeks in the 6 months prior to randomization. 4. Volunteers who have undergone recent surgery. 5. Volunteers on any medicines, including nutritional, Ayurveda/ herbal supplements. 6. Any women currently pregnant as excluded (by a positive hCG test)/ planning to get pregnant during the study period. 7. Allergies or allergic reactions to any of the ingredients of LLC. 8. Presence of definite or probable drug-induced liver injury. In the case of lipid lowering, anti-hypertensive or anti-diabetic medications that are suspected to cause elevation of aminotransferases, patients will be eligible if treatment is associated with stable enzyme levels for at least 6 months. 9. Chronic kidney disease. 10. Presence of clinical, radiological, biochemical and or endoscopic evidence of cirrhosis. 11. Any condition that, in the opinion of the clinician, would contraindicate the patient’s participation. 12. Patients who are on pharmacological treatment for MAFLD.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in Liver stiffness measurement (LSM) as determined by fibroscan of liver from baseline to 12 months. [Baseline and at 12th months] | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in Hepatic steatosis with controlled attenuation parameter (CAP) as determined by fibroscan from baseline to 12 months. [Baseline and at 12th months] Reduction in Anthropometric parameters: waist circumference, weight and body mass index (BMI) from baseline to 12 months. [ Baseline and at 12th months] Reduction in levels of Aspartate Transaminase (AST), Alanine Transaminase (ALT) and Gamma Glutamyl Transpeptidase (GGT) from baseline to 12 months. [ Baseline and at 12th months] | — |
Countries
Sri Lanka
Contacts
Public ContactProf. Jennifer Perera
Emeritus Professor
Outcome results
None listed