Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 13 of 21 for:    fenugreek

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02303314
Recruitment Status : Completed
First Posted : November 27, 2014
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Amir Hossein Babaei, 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.

Condition or disease Intervention/treatment Phase
Non-alcoholic Fatty Liver Disease Drug: Trigonella Foenum-graecum Seed Extract Drug: Drug: Placebo Phase 2 Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : November 2014
Actual Primary Completion Date : August 2017
Actual Study Completion Date : September 2017


Arm Intervention/treatment
Drug: Trigonella Foenum-graecum
in this group patients use Trigonella Foenum-graecum seed extract twice daily.
Drug: Trigonella Foenum-graecum Seed Extract
Drug: Placebo
in this group patients use placebo twice daily.
Drug: Drug: Placebo



Primary Outcome Measures :
  1. Liver stiffness change [ Time Frame: At baseline and 12 weeks after intervention ]
    Assessment by Fibroscan



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02303314


Locations
Layout table for location information
Iran, Islamic Republic of
Shiraz University of Medical Sciences
Shiraz, Fars, Iran, Islamic Republic of
Sponsors and Collaborators
Shiraz University of Medical Sciences
Investigators
Layout table for investigator information
Principal Investigator: Seyed Alireza Taghavi Shiraz University of Medical Sciences

Layout table for additonal information
Responsible Party: Amir Hossein Babaei, Students of Medicine, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02303314     History of Changes
Other Study ID Numbers: CT-P-9362-6352
IRCT2013102015083N1 ( Registry Identifier: Iranian Registry of Clinical Trials )
CT-P-9362-6352 ( Other Identifier: Shirazums )
First Posted: November 27, 2014    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases