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

Tanta University44 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatic and Post Hepatic Jaundice

Interventions

N-acetylcysteineDRUG

Patients will receive oral N-acetylcysteine 600 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 known hypersensitivity to N-acetylcysteine.

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 after 3 months.

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

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.

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

Patients' symptoms, 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: 3 months.

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 after 3 months.

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 after 3 months.

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

Data from ClinicalTrials.gov

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