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

Tanta University

Status and phase: Completed; Phase 2

Conditions: Hepatic and Post Hepatic Jaundice

Treatments: Drug: N-acetylcysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT06236165

00543/2024

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Control arm

No Intervention group

Description:

22 patients who will receive supportive treatment for jaundice only, for 3 months.

NAC arm

Experimental group

Description:

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

Treatment:

Drug: N-acetylcysteine