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

NCT02303314 | Completed Phase 2 DMC

• 2 other identifiers: CT-P-9362-6352IRCT2013102015083N1
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• Liver stiffness change

  Assessment by Fibroscan

  At baseline and 12 weeks after intervention

Study Arms (2)

Drug: Trigonella Foenum-graecum

OTHER

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

Drug: Trigonella Foenum-graecum Seed Extract

Drug: Placebo

OTHER

in this group patients use placebo twice daily.

Drug: Drug: Placebo

Interventions

Trigonella Foenum-graecum Seed Extract DRUG

Drug: Trigonella Foenum-graecum

Drug: Placebo DRUG

Drug: Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

Study Sites (1)

Shiraz University of Medical Sciences

Shiraz, Fars, Iran

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Seyed Alireza Taghavi

  Shiraz University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Students of Medicine

Study Record Dates

• First Submitted: November 21, 2014
• First Posted: November 27, 2014
• Study Start: November 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: September 1, 2017
• Last Updated: September 25, 2017

Record last verified: 2017-09

Locations

IR (1)