Hepatic and Post Hepatic Jaundice
Conditions
Keywords
Jaundice, N-acetylcysteine, TAC, TNF-α, Bilirubin
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.
Interventions
DRUGN-acetylcysteine
Patients will receive oral N-acetylcysteine 600 mg twice daily in addition to supportive treatment, for 3 months.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change from baseline in (Total and Direct bilirubin) | 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. |
| The change from baseline in alanine transaminase (ALT), aspartate transaminase (AST) and alkaline phosphatase (ALP) | 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
| Measure | Time frame | Description |
|---|---|---|
| Patients' symptoms, 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. |
| 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. |
| 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 liver-fatty acid binding protein (L-FABP) level | 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. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORSamah Hussein
Tanta University
Outcome results
None listed