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Completed

NCT Number: NCT06236165

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

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

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Key information

Conditions

Hepatic and Post Hepatic Jaundice Hyperbilirubinemia Jaundice Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Pharmacy, Tanta University

Tanta, 31111, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 known hypersensitivity to N-acetylcysteine.

Treatment and study plan

N-acetylcysteine

Drug

Patients will receive oral N-acetylcysteine 600 mg twice daily in addition to supportive treatment, for 3 months.

Primary outcomes

  1. The change from baseline in (Total and Direct bilirubin)

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

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

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

Secondary outcomes

  1. Patients' symptoms, 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.

  2. 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.

  3. 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

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

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 1, 2024
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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