Comparing the effects of herbal tea made of Osbeckia octandra on hepatic steatosis and hepatic fibrosis in patients with Metabolic associated fatty liver disease (MAFLD compared to standard therapy: a randomized control trial.

INTERVENTION: Setting: Department of Gastroenterology, Colombo North Teaching Hospital, Ragama Randomization: Simple randomization Intervention: Product: The airtight dry ingredient sachet packet will be prepared by including O. octandra (Heen Bowitiya) plant powder (6g). The O. octandra powder will be purchased from an authenticated seller. The herbal tea will be prepared by dipping the contents of the packet in 1 cup (250ml) of boiling water for 10 minutes and then it will be strained by a tea‐strainer. Frequency: 250ml 3 times a week. Randomization: Simple randomization Control: Patients with MAFLD under standard therapy. CONDITION: metabolic dysfunction associated fatty liver disease PRIMARY OUTCOME: 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 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 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]; SECONDARY OUTCOME: 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]; 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 <40 mg/dl (<1.0 mmol/L) for men and <50 mg/dl (<1.3 mmol/L) for women or specific drug treatment o Prediabetes (i.e., fasting glucose levels 100 to 1