ClinicalTrials.gg
CompletedNCT06236165Updated Jul 22, 2026

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

A Phase 2 interventional study of N-acetylcysteine in Hepatic and Post Hepatic Jaundice, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-22.

Sponsored by Tanta University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hepatic and Post Hepatic Jaundice

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Keywords

  • Jaundice
  • N-acetylcysteine
  • TAC
  • TNF-α
  • Bilirubin
03

In context

Jaundice

84 studies on the registry are indexed under Jaundice; 13 are open to participants now.

This study's enrollment of 44 is below the median of 79 across 47 interventional studies indexed under Jaundice.

Browse Jaundice studies →

Lead sponsor

Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients age 18-70 years old.
  • Patients diagnosed with jaundice and increased level direct ≥ 3 mg/dL.

Exclusion criteria

Exclusion Criteria:

  • Pregnancy.
  • Nursing mothers.
  • Patients with increased indirect level.
  • Patients who have Gilbert syndrome or Crigler Najjar syndrome.
  • History of known to N-acetylcysteine.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
44 participants (actual)

Study arms

  • 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

Interventions

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

06

What researchers measure

Primary outcomes

  1. 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.

  2. 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

  1. 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.

  2. 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.

  3. 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.

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

    Assessment of liver-fatty acid binding protein (L-FABP) 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

07

Study locations

1 site
  • Faculty of Pharmacy, Tanta University
    Tanta, 31111, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06236165
Lead sponsor
Tanta University
Responsible party
Samah Hussein Mohamed (Master degree in Clinical Pharmacy, Tanta University) — Principal investigator
First posted
Feb 1, 2024
Start date
Feb 14, 2024
Primary completion
Jan 22, 2025
Completion
Jan 22, 2025
Last update
Jul 22, 2026

Study contacts

Samah Hussein
principal investigator · Tanta University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Acetylcysteine

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