Hepatobiliary Disorders
Conditions
Keywords
Jaundice, Pentoxifylline, TAC, TNF-α, Bilirubin
Brief summary
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
Interventions
DRUGPentoxifylline
Patients will receive oral Pentoxifylline 400 mg twice daily in addition to supportive treatment, for 3 months.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change from baseline in (Total and Direct bilirubin) | The participants will be assessed before initiation of the study (baseline), and at the end of the study up to12 weeks. | measurement of(Total and Direct bilirubin) in mg/dL from blood samples will be assessed for all participants. |
| The change from baseline in aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase (ALP) | The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events and toxicity | up to 12 weeks | Adverse events and toxicity will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5 |
| Change in total antioxidant capacity (TAC) level, | The participants will be assessed before initiation of the study (baseline), and at the end of the study up to 12 weeks. | Assessment of total antioxidant capacity (TAC) level by ELISA Kits according to manufacturer's instructions. |
| Change in tumor necrosis factor alpha (TNF-α) | The participants will be assessed before initiation of the study (baseline), and at the end of the study up to 12 weeks. | Assessment of tumor necrosis factor alpha (TNF-α) level by ELISA Kits according to manufacturer's instructions. |
| Change in liver-fatty acid binding protein (L-FABP) | The participants will be assessed before initiation of the study (baseline), and at the end of the study up to 12 weeks. | Assessment of liver-fatty acid binding protein (L-FABP) level by ELISA Kits according to manufacturer's instructions. |
Countries
Egypt
Outcome results
None listed