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

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.

Study Overview

• Status: Completed
• Conditions: Non-alcoholic Fatty Liver Disease
• Intervention / Treatment: Drug: Trigonella Foenum-graecum Seed Extract; Drug: Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Fars
    • Shiraz, Fars, Iran, Islamic Republic of
      • shiraz University of medical sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Drug: Trigonella Foenum-graecum; in this group patients use Trigonella Foenum-graecum seed extract twice daily.	Drug: Trigonella Foenum-graecum Seed Extract
Other: Drug: Placebo; in this group patients use placebo twice daily.	Drug: Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver stiffness change	Assessment by Fibroscan	At baseline and 12 weeks after intervention

Collaborators and Investigators

• Sponsor: Shiraz University of Medical Sciences
• Investigators: Principal Investigator: Seyed Alireza Taghavi, shiraz University of medical sciences

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: November 21, 2014
• First Submitted That Met QC Criteria: November 24, 2014
• First Posted (Estimate): November 27, 2014

Study Record Updates

• Last Update Posted (Actual): September 25, 2017
• Last Update Submitted That Met QC Criteria: September 21, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: CT-P-9362-6352 (Other Identifier: Shirazums); IRCT2013102015083N1 (Registry Identifier: Iranian Registry of Clinical Trials)