Does the daily administration of herbal capsule Asparagus falcatus L. (500 mg) for three months have efficacy and safety in patients with non-alcoholic fatty liver disease?

1. Study setting: Department of Biochemistry and Medicine, Faculty of Medicine, University of Ruhuna.

2. Randomization: Simple randomization using a computer-generated random number table, concealment via sequentially numbered sealed envelopes.

3.Intervention: Test-Oral capsules containing freeze-dried material of aqueous refluxed leaf extract of Asparagus falcatus L. (500mg) once daily for 3 months

1. Control: Placebo-Oral capsules containing corn starch (500mg) once daily for 3 months

• Patients aged between 20 -60 yrs,
• Male and female
• NAFLD; through mild or moderately elevated liver enzymes (NHANES III criteria-AST >37 IU/L or ALT > 40 IU/L for males and AST or ALT >31 IU/L in females, but not greater than the three times the upper limit of 37/40 IU/L and 31 IU/L respectively) AND -Presence of fatty liver according to the established ultrasound criteria (two out of the following three criteria: increased echogenicity of the liver compared to the kidney and spleen, obliteration of the vascular architecture of the liver, and deep attenuation of the ultrasonic signal -Able to communicate effectively with the study personnel and understand the nature of the study, and be willing to give written informed consent at the enrollment

• Pregnancy, lactation, a history of documented acute or chronic liver disease, including acute hepatitis of any cause, viral hepatitis, autoimmune hepatitis, hemochromatosis, vascular disease of the liver, gastrointestinal surgery, Wilson disease, ?-1antitrypsin deficiency, or any illness with jaundice · Daily alcohol consumption of more than 20 g/day (two 30 mL drinks) throughout life and consumption of any alcohol for the past six months · Chronic illnesses including rheumatoid arthritis, severe osteoarthritis, symptomatic heart failure, type 1 and 2 diabetes mellitus, myocardial infarction within the last 6 months, acromegaly, clinically apparent hypothyroidism, nephrotic syndrome, and chronic kidney disease, stage III and above, hypertension Patients who are on lipid-lowering drugs (statins, omega -3 polyunstaurated fatty acids, etc.) or drugs affecting lipid metabolism (full dose thiazides, corticosteroids, immunosuppressants) · Malignancies · Extreme body habitus (BMI >40 kg/m2), who are on active drug treatment for obesity · Had used antioxidants such as vitamin E, vitamin C, glutathione, alpha tocopherol, or non-prescribed complementary alternative medications (including dietary supplements, megadose vitamins, herbal preparations and special herbal teas) within 30 days before screening. · Patients who are on weight-loss diets during the three months before the study · Individuals who are undernourished · Individuals taking any Western, Ayurvedic, or other medications on long-term basis · Individuals with a positive family history of liver disease, such as hereditary hemochromatosis, Wilson's disease