Clinical trial NCT02303314: Efficacy of Oral Trigonella Foenum-graecum Seed Extract Vs Placebo in Treatment of None Alcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Non-alcoholic Fatty Liver Disease
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-11-27
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Liver stiffness change
timeFrame: At baseline and 12 weeks after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz University of Medical Sciences
state: Fars
Study officials:
affiliation: Shiraz University of Medical Sciences
name: Seyed Alireza Taghavi
role: PRINCIPAL_INVESTIGATOR
References: