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

Phase 3

Completed

• Conditions: Hepatic and Post Hepatic Jaundice
• Interventions: Drug: N-acetylcysteine

• Registration Number: NCT06236165
• Lead Sponsor: Tanta University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-24
• Study First Submitted QC: 2024-01-24
• Study First Posted: 2024-02-01
• Study Start: 2024-02-14
• Status Verified: 2025-01
• Primary Completion: 2025-01-22
• Study Completion: 2025-01-22
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 known hypersensitivity to N-acetylcysteine.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NAC arm	N-acetylcysteine	22 patients who will receive oral N-acetylcysteine 600 mg twice daily in addition to supportive treatment, for 3 months.

Primary Outcome Measures

Name	Time	Method
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 after 3 months.	Assessment of tumor necrosis factor alpha (TNF-α) level by ELISA Kits according to manufacturer's instructions
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 after 3 months.	Assessment of total antioxidant capacity (TAC) level by ELISA Kits according to manufacturer's instructions.

Secondary Outcome Measures

Name	Time	Method
Adverse events and toxicity	3 months.	Adverse events and toxicity will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.
Follow up of liver function	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.

Trial Locations

Locations (1)

Faculty of Pharmacy, Tanta University; 🇪🇬 Tanta, Egypt