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

NCT ID: NCT02303314

Last Updated: 2017-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2017-09-30

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.

Conditions

Non-alcoholic Fatty Liver Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Drug: Trigonella Foenum-graecum

in this group patients use Trigonella Foenum-graecum seed extract twice daily.

Group Type: OTHER

Trigonella Foenum-graecum Seed Extract

Intervention Type: DRUG

Drug: Placebo

in this group patients use placebo twice daily.

Group Type: OTHER

Drug: Placebo

Intervention Type: DRUG

Interventions

Trigonella Foenum-graecum Seed Extract

Intervention Type: DRUG

Drug: Placebo

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shiraz University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Amir Hossein Babaei

Students of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seyed Alireza Taghavi

Role: PRINCIPAL_INVESTIGATOR

Shiraz University of Medical Sciences

Locations

Shiraz University of Medical Sciences

Shiraz, Fars, Iran

Countries

Iran

Other Identifiers

IRCT2013102015083N1

Identifier Type: REGISTRY

Identifier Source: secondary_id

CT-P-9362-6352

Identifier Type: OTHER

Identifier Source: secondary_id

CT-P-9362-6352

Identifier Type: -

Identifier Source: org_study_id