Evaluation of Efficacy, Safety and Molecular Mechanism of Pentoxifylline Supplementation in Patients With Hepatic and Obstructive Jaundice

Tanta University45 enrolled

Overview

Investigating the efficacy, safety, and molecular mechanism of Pentoxifylline supplementation in improving elevated direct bilirubin level and liver function tests in patients with hepatic and post-hepatic jaundice

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatobiliary Disorders

Interventions

PentoxifyllineDRUG

Patients will receive oral Pentoxifylline 400 mg twice daily in addition to supportive treatment, for 3 months.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients age 18-70 years old. * Patients diagnosed with jaundice and increased level direct bilirubin ≥ 3 mg/dL. Exclusion Criteria: * Pregnancy. * Nursing mothers. * Patients with increased indirect bilirubin level. * Patients who have Gilbert syndrome or Crigler Najjar syndrome. * History of intolerance and hypersensitivity to Pentoxifylline or to xanthine derivatives such as caffeine, theophylline. * Recent hemorrhage. * Patients who have risk factors potentially complicated by hemorrhage. * Taking anticoagulants or antiplatelet therapy.

Locations (1)

Faculty of Pharmacy, Tanta University

Tanta, Egypt

Outcomes

Primary Outcomes

The change from baseline in (Total and Direct bilirubin)

measurement of(Total and Direct bilirubin) in mg/dL from blood samples will be assessed for all participants.

Time frame: The participants will be assessed before initiation of the study (baseline), and at the end of the study up to12 weeks.

The change from baseline in aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase (ALP)

measurement of aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase (ALP) all in U/L from blood samples will be assessed for all participants.

Time frame: The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.

Secondary Outcomes

Adverse events and toxicity

Adverse events and toxicity will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5

Time frame: up to 12 weeks

Change in total antioxidant capacity (TAC) level,

Assessment of total antioxidant capacity (TAC) level by ELISA Kits according to manufacturer's instructions.

Time frame: The participants will be assessed before initiation of the study (baseline), and at the end of the study up to 12 weeks.

Change in tumor necrosis factor alpha (TNF-α)

Assessment of tumor necrosis factor alpha (TNF-α) level by ELISA Kits according to manufacturer's instructions.

Time frame: The participants will be assessed before initiation of the study (baseline), and at the end of the study up to 12 weeks.

Change in liver-fatty acid binding protein (L-FABP)

Assessment of liver-fatty acid binding protein (L-FABP) level by ELISA Kits according to manufacturer's instructions.

Data from ClinicalTrials.gov

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