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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-03

Study Completion Date

2025-03-19

Brief Summary

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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

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Detailed Description

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Conditions

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Hepatobiliary Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control arm

20 patients who will receive supportive treatment for jaundice only, for 3 months.

Group Type NO_INTERVENTION

No interventions assigned to this group

PTX arm

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

Group Type EXPERIMENTAL

Pentoxifylline

Intervention Type DRUG

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

Interventions

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Pentoxifylline

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

Intervention Type DRUG

Eligibility Criteria

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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.
* Patients with Child Paugh C score (10-15 point).
* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No