Clinical Study Evaluating Efficacy, Safety and Molecular Mechanism of Both N-acetylcysteine and Pentoxifylline Supplementation in Patients With Hepatic and Post Hepatic Jaundice

February 14, 2024 updated by: Samah Hussein Mohamed, Tanta University
Investigating the efficacy, safety, and molecular mechanism of both N-acetylcysteine and Pentoxifylline supplementation in improving elevated direct bilirubin level and liver function tests in patients with hepatic and post-hepatic jaundice.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.
  • History of known hypersensitivity to N-acetylcysteine.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control arm
22 patients who will receive supportive treatment for jaundice only, for 3 months.
Experimental: NAC arm
22 patients who will receive oral N-acetylcysteine 600 mg twice daily in addition to supportive treatment, for 3 months.
Drug: N-acetylcysteine
Patients will receive oral N-acetylcysteine 600 mg twice daily in addition to supportive treatment, for 3 months.
Experimental: PTX arm
22 patients who will receive oral Pentoxifylline 400 mg twice daily in addition to supportive treatment, for 3 months.
Drug: Pentoxifylline
Patients will receive oral Pentoxifylline 400 mg twice daily in addition to supportive treatment, for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in total antioxidant capacity (TAC) level
Time Frame: The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.
Assessment of total antioxidant capacity (TAC) level by ELISA Kits according to manufacturer's instructions.
The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.
Change in tumor necrosis factor alpha (TNF-α)
Time Frame: The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.
Assessment of tumor necrosis factor alpha (TNF-α) level by ELISA Kits according to manufacturer's instructions
The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events and toxicity
Time Frame: 3 months.
Adverse events and toxicity will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.
3 months.
Follow up of liver function
Time Frame: The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.
measurement of alanine transaminase (ALT) and aspartate transaminase (AST) both in U/L from blood samples will be assessed for all participants.
The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: Samah Hussein, faculty of pharmacy Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

January 24, 2024

First Submitted That Met QC Criteria

January 24, 2024

First Posted (Actual)

February 1, 2024

Study Record Updates

Last Update Posted (Actual)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00543/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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