Status:
COMPLETED
Efficacy of Oral Trigonella Foenum-graecum Seed Extract Vs Placebo in Treatment of None Alcoholic Fatty Liver Disease
Lead Sponsor:
Shiraz University of Medical Sciences
Conditions:
Non-alcoholic Fatty Liver Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
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 ran...
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 les...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT02303314
Start Date
November 1 2014
End Date
September 1 2017
Last Update
September 25 2017
Active Locations (1)
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1
Shiraz University of Medical Sciences
Shiraz, Fars, Iran