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.

Not Applicable

• Conditions: metabolic dysfunction associated fatty liver disease

• Registration Number: SLCTR/2022/030

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: Not specified

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:
ohistological (biopsy), imaging or blood biomarker evidence of hepatic steatosis
owith one of the following three criteria,
oOverweight/ obesity (BMI ?23 kg/m2 in Asians)
oType 2 diabetes mellitus (FBS ?7.0mmol/L (126mg/dL), HbA1C ? 6.5%, OGTT ? 200 mg/dL
oEvidence of metabolic dysregulation (at least 2 of the following criteria need to be met)
oWaist circumference ?90/80 cm in Asian men and women
oBlood pressure ?130/85 mmHg or specific drug treatment
oPlasma triglycerides ?150 mg/dl (?1.70 mmol/L) or specific drug treatment
oPlasma 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
oPrediabetes (i.e., fasting glucose levels 100 to 125 mg/dl [5.6 to 6.9 mmol/L], or 2-hour post-load glucose levels 140 to 199 mg/dl [7.8 to 11.0 mmol] or HbA1c 5.7% to 6.4% [39 to 47 mmol/mol])
oHomeostasis model assessment of insulin resistance score ?2.5
oPlasma high-sensitivity C-reactive protein level >2 mg/L
•Age 18–60 years (male and female)

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified