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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm | No Intervention | 22 patients who will receive supportive treatment for jaundice only, for 3 months. | |
| NAC arm | Experimental | 22 patients who will receive oral N-acetylcysteine 600 mg twice daily in addition to supportive treatment, for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-acetylcysteine | Drug | Patients will receive oral N-acetylcysteine 600 mg twice daily in addition to supportive treatment, for 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in total antioxidant capacity (TAC) level | Assessment of total antioxidant capacity (TAC) level by ELISA Kits according to manufacturer's instructions. | 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 | The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events and toxicity | Adverse events and toxicity will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5. | 3 months. |
| Follow up of liver function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samah Hussein | Tanta University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Pharmacy, Tanta University | Tanta | 31111 | Egypt |
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measurement of alanine transaminase (ALT) and aspartate transaminase (AST) both in U/L from blood samples will be assessed for all participants.
| The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months. |
| ID | Term |
|---|---|
| D007565 | Jaundice |
| ID | Term |
|---|---|
| D006932 | Hyperbilirubinemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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