Protocol summary

Summary
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, we 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.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013102015083N1
Registration date: 2014-09-01, 1393/06/10
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-09-01, 1393/06/10
Registrant information
Name
Amir Hossein Babaei
Name of organization / entity
Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 917 739 5073
Email address
babaei@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2016-01-19, 1394/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of oral Trigonella foenum-graecum seed extract and placebo in the treatment of none alcoholic fatty liver disease
Public title
Effect ot Fenugreek in treatment of fatty liver
Purpose
Treatment
Inclusion/Exclusion 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; and those who cannot use contraceptives.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences - Zand street
City
Shiraz
Postal code
71345-1583
Approval date
2014-08-03, 1393/05/12
Ethics committee reference number
CT-P-9362-6352

Health conditions studied

1

Description of health condition studied
none alcoholic fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified

Primary outcomes

1

Description
Liver stiffness
Timepoint
At baseline and 12 weeks after intervention
Method of measurement
Fibro scan

2

Description
insulin resistance
Timepoint
At baseline and 6 and 12 weeks after intervention
Method of measurement
blood sample

Secondary outcomes

empty

Intervention groups

1

Description
Control group, in addition to diet and exercise recommendations, use placebo capsules for 3 months.
Category
Placebo

2

Description
Intervention group, in addition to diet and exercise recommendations, use capsules containing fenugreek hydro alcoholic extract 1g / d for 3 months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Motahhari Hospital
Full name of responsible person
Ali reza Taghavi
Street address
Namzi Sq.
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali reza Taghavi
Street address
Karim Khan Street - Namazi Hospital- Gastroenterology and Hepatology Research Center
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
AMir Hossein Babaei
Position
Medical Student
Other areas of specialty/work
Street address
Zand street - School of Medicine
City
Shiraz
Postal code
Phone
00
Fax
Email
babaei93@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali reza Taghavi
Position
Associate Professor of Gastroenterology
Other areas of specialty/work
Street address
Karim Khan Street - Namazi Hospital- Gastroenterology and Hepatology Research Center
City
Shiraz
Postal code
Phone
+98 71 1647 4263
Fax
Email
ataghavi@sums.ac.ir taghavia@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Amir Hossein Babaei
Position
Medical Student
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
babaei93@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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