Ignite Creation Date:
2024-05-06 @ 3:30 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02303314
Status:
COMPLETED
Last Update Posted:
2017-09-25
First Post:
2014-11-21
Brief Title:
Efficacy of Oral Trigonella Foenum-graecum Seed Extract Vs Placebo in Treatment of None Alcoholic Fatty Liver Disease
Sponsor:
Shiraz University of Medical Sciences
Organization:
Shiraz University of Medical Sciences
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 15 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 1gd 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CT-P-9362-6352 | OTHER | Shirazums | None |
| IRCT2013102015083N1 | REGISTRY | None | None |