Ignite Creation Date:
2024-05-06 @ 4:24 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04977661
Status:
COMPLETED
Last Update Posted:
2021-07-27
First Post:
2021-07-07
Brief Title:
Comparing the Effects of Vitamin E Ursodeoxycholic Acid and Pentoxyfylline on Egyptian Non-alcoholic Steatohepatitis NASH Patients
Sponsor:
Kafrelsheikh University
Organization:
Kafrelsheikh University
Study Overview
Official Title:
A Randomized Study to Compare the Efficacy of Vitamin E Ursodeoxycholic Acid and Pentoxyfylline on Egyptian Patients With Non-alcoholic Fatty Liver Disease Using IL6 and CCL2 as a Predictors of Non-alcoholic Steatohepatitis
Status:
COMPLETED
Status Verified Date:
2021-07
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:
We conducted a 3-month randomized single-blind study in 102 Egyptian NASH patients who were divided into three groups group 1 included 34 patients received Vit E 400 mg twice a day group 2 included 34 patients received UDCA 250 mg twice a day and group 3 included 34 patients received PTX 400 mg twice daily for 3 months The following parameters were measured both before and after intervention intake liver aminotransferases AST ALT cytokine and chemokine IL6 and CCL2MPC-1 albumin total bilirubin direct bilirubin total cholesterol triglyceride LDL HDL
Detailed Description:
This was a 3-month prospective randomized and single blind study Participants were recruited from the outpatient clinic and hepatology gastroenterology and infectious diseases department at Kafrelsheikh University Hospital between February 2020 and January 2021 Two-hundred and five Egyptian patients diagnosed with NAFLD with potential clinical inclusion criteria were invited for a screening session to determine their eligibility for the study Patients were enrolled in the study if they are 18 years old had evidence for NASH persistently elevated alanine aminotransferase ALT 15 times the upper limit of normal imaging ultrasound showing fatty infiltration and histological evidence of NASH after biopsy macrovascular steatosis ballooning degeneration of hepatocytes scattered lobular inflammation and apoptotic bodiesOne hundred and forty-six patients were excluded from the study either because they did not meet the inclusion criteria n 135 or refused to enroll in the study n 11 Qualifying participants n 102 were randomly assigned to one of the three treatment groups using a computer-generated randomization sequence Group I n 34 received 400 IU Vitamin E Vitamin E 400 IU MEPACO Pharmaceutical Company Sharqia Egypt twice daily for 3 months Group II n 34 received 250 mg Ursodeoxycholic acid Ursofalk 250 mg MINAPHARM Pharmaceutical Company Cairo Egypt twice daily for 3 months Group III n 34 received 400 mg sustained release SR Film-Coated Tablets of pentoxifylline Trental 400 mg SANOFI Pharmaceutical Company Cairo Egypt twice daily for 3 months Patients were followed up every week to ensure compliance drug adherence and to report side effects or drop out from the studyThe following parameters were measured both before and after intervention intake liver aminotransferases AST ALT cytokine and chemokine IL6 and CCL2MPC-1 albumin total bilirubin direct bilirubin total cholesterol triglyceride LDL HDL
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None