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

Phase 2

Completed

• Conditions: Non-alcoholic Fatty Liver Disease
• Interventions: Drug: Trigonella Foenum-graecum Seed Extract

• Registration Number: NCT02303314
• Lead Sponsor: Shiraz University of Medical Sciences

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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-21
• Study First Submitted QC: 2014-11-24
• Study First Posted: 2014-11-27
• Primary Completion: 2017-08
• Status Verified: 2017-09
• Study Completion: 2017-09
• Last Update Submitted: 2017-09-21
• Last Update Posted: 2017-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug: Trigonella Foenum-graecum	Trigonella Foenum-graecum Seed Extract	in this group patients use Trigonella Foenum-graecum seed extract twice daily.

Primary Outcome Measures

Name	Time	Method
Liver stiffness change	At baseline and 12 weeks after intervention	Assessment by Fibroscan

Trial Locations

Locations (1)

Shiraz University of Medical Sciences; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of