Efficacy of Oral Trigonella Foenum-graecum Seed Extract Vs Placebo in Treatment of None Alcoholic Fatty Liver Disease

Shiraz University of Medical Sciences

Status and phase

Completed

Phase 3

Phase 2

Conditions

Non-alcoholic Fatty Liver Disease

Treatments

Drug: Trigonella Foenum-graecum Seed Extract

Drug: Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02303314

IRCT2013102015083N1 (Registry Identifier)

CT-P-9362-6352 (Other Identifier)

Details and patient eligibility

About

This study design to examine performance of trigonella foenum-graecum (TFG) in treatment of non-alcoholic fatty liver disease. Base on inclusion and exclusion criteria, 50 patients select and then randomize into intervention and control groups. Two group use capsules which contain TFG or placebo, respectively.

Full description

This study design to examine performance of trigonella foenum-graecum in treatment of non-alcoholic fatty liver disease. Patients 18-70 year old with the levels of ALT and AST greater than 1.5 and less than 10 times normal level, and ultrasound evidence confirm fatty liver disease include in study. Patients with alcohol consumption, other liver disease and taking medications that cause liver injury, exclude. Base on inclusion and exclusion criteria, 50 patients select and then randomize into intervention and control groups. Control group, in addition to diet and exercise recommendations take placebo capsules for 3 months. Intervention group, in addition to diet and exercise recommendations, use capsules containing hydro-alcoholic extract of fenugreek 1g/d for 3 months. At baseline and 6 and 12 weeks after intervention, the investigators measure FBS, insulin, insulin resistance, Albumin, Aspartate transaminase, Alanine Aminotransferase, Alkaline phosphatase, Total bilirubin, Direct bilirubin, HbA1c, total cholesterol, LDL, HDL, TG, High sensitivity C reactive protein and Creatinine. At baseline and 12 weeks after intervention fibroscan perform to evaluate the amount of fat in liver. In order to decrease bias, patient, physician who performs fibroscan and the person analyzing the data are blind to group drugs.

Enrollment

35 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

The level of ALT and AST greater than 1.5 and less than 10 times normal level
Ultrasound evidence confirm fatty liver disease; age between 18-70 years old
Negative pregnancy test for women in reproductive age (up to two weeks prior to the study)
Negative for hepatitis B and C
BMI: 18.5 to 40
Sign the consent form.

Exclusion criteria

History of more than one unit of alcohol consumption (one value for the Spirits (vodka; whiskey)
Wine and Beer are respectively 30-45 cc; 120-150 cc and 360 cc.)
Fatty liver controller medications
Glucose lowering drugs
Cholesterol lowering drugs
Hypotensive drugs
Consumption of vitamin E
Taking coenzyme Q10
Administration of corticosteroids & glucocorticoids
Thyroxin administration
Administration of drugs that cause fatty liver
Diabetes (type 1 and 2)
History of cancer in the past
Hepatocellular carcinoma
Renal failure (creatinine> 1.5 x ULN)
Chronic pancreatitis
Cirrhosis
Uncontrolled hypertension (above 180 mm Hg systolic blood pressure); heart disease
Autoimmune hepatitis
Primary biliary cirrhosis
Primary sclerosing cholangitis (alkaline phosphatase levels greater than 3 times normal)
Wilson's disease
Alpha-1 antitrypsin deficiency and coronary artery disease
Symptoms of hypothyroidism
Hyperthyroidism
Disorders of the hypothalamic - pituitary
Liver transplantation
Pregnant or lactating women
Those who cannot use contraceptives.