metabolic dysfunction associated fatty liver disease
Conditions
Interventions
Setting: Department of Gastroenterology, Colombo North Teaching Hospital, Ragama
Randomization: Simple randomization
Intervention: Product: The airtight dry ingredient sachet packet will be prepared b
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: • All patients with ultrasonically proven fatty liver disease, who are attending the Liver Clinic of Gastroenterology & Hepatology Department at CNTH-Ragama and NHSL Colombo • MAFLD patients diagnosed based on following criteria: o histological (biopsy), imaging or blood biomarker evidence of hepatic steatosis o with one of the following three criteria, o Overweight/ obesity (BMI ?23 kg/m2 in Asians) o Type 2 diabetes mellitus (FBS ?7.0mmol/L (126mg/dL), HbA1C ? 6.5%, OGTT ? 200 mg/dL o Evidence of metabolic dysregulation (at least 2 of the following criteria need to be met) o Waist circumference ?90/80 cm in Asian men and women o Blood pressure ?130/85 mmHg or specific drug treatment o Plasma triglycerides ?150 mg/dl (?1.70 mmol/L) or specific drug treatment o Plasma HDL-cholesterol 2 mg/L • Age 18–60 years (male and female)
Exclusion criteria
Exclusion criteria: • History of alcohol consumption of ?14 units/week for women and ?21 units/week for men. • Patients who have been diagnosed with other known causes of liver disease (HBV and HCV and autoimmune hepatitis) • Presence of clinical, radiological, biochemical and or endoscopic evidence of cirrhosis • Patients who are on medications for other chronic disease including hypertension, diabetes mellitus and hyperlipidaemia. • Any diagnosed malignancy • Breast feeding, pregnant, and/or planning for pregnancy in the within one year • The patients who are already taking or recently used (within 6 months) herbal preparations or Ayurvedic treatment for any condition. • People who are allergic to herbal preparations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver Fibrosis by Fibroscan. Liver stiffness measurement (LSM) using non-invasive transient elastography (TE) is used to assess the hepatic fibrosis. [Baseline and four months after intervention] Liver Steatosis by Fibroscan Controlled Attenuation Parameter (CAP) score is a measurement of fatty change in theur liver to provide a steatosis grade. The CAP score is measured in decibels per meter (dB/m). [ ] Liver Steatosis by Fibroscan. Controlled Attenuation Parameter (CAP) score is a measurement of fatty change in the liver to provide a steatosis grade. The CAP score is measured in decibels per meter (dB/m). [ Baseline and four months after intervention] Liver Steatosis by Fibroscan. Controlled Attenuation Parameter (CAP) score is a measurement of fatty change in the liver to provide a steatosis grade. The CAP score is measured in decibels per meter (dB/m). [ Baseline and four months after intervention] Liver Steatosis by Fibroscan. Controlled Attenuation Parameter (CAP) score is a measurement of fatty change in the liver to provide a steatosis grade. The CAP score is measured in decibels per meter (dB/m). [ Baseline and four months after intervention] Liver Steatosis by Fibroscan. Controlled Attenuation Parameter (CAP) score is a measurement of fatty change in the liver to provide a steatosis grade. The CAP score is measured in decibels per meter (dB/m). [ Baseline and four months after intervention] Liver Steatosis by Fibroscan. Controlled Attenuation Parameter (CAP) score is a measurement of fatty change in the liver to provide a steatosis grade. The CAP score is measured in decibels per meter (dB/m). [ Baseline and four months after intervention] Liver Steatosis by Fibroscan. Controlled Attenuation Parameter (CAP) score is a measurement of fatty change in the liver to provide a steatosis grade. The CAP score is measured in decibels per meter (dB/m). [ Baseline and four months after intervention] Liver Steatosis by Fibroscan. Controlled Attenuation Paramet | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in mean of following parameters: AST, ALT, GGT, ALP, total protein, albumin, globulin, total bilirubin and direct bilirubin, lipid profile values, TSH, T3 T4, HbA1c, Fasting blood glucose level, high-sensitivity CRP [Baseline and four months after intervention] | — |
Countries
Sri Lanka
Contacts
Public ContactDilhara Karunaratna
Senior lecturer
Outcome results
None listed