Clinical Study Evaluating Efficacy, Safety and Molecular Mechanism of N-acetylcysteine Supplementation in Patients With Hepatic and Post Hepatic Jaundice
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Change in tumor necrosis factor alpha (TNF-α)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age 18-70 years old.
- •Patients diagnosed with jaundice and increased level direct bilirubin ≥ 3 mg/dL.
排除标准
- •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.
研究组 & 干预措施
NAC arm
22 patients who will receive oral N-acetylcysteine 600 mg twice daily in addition to supportive treatment, for 3 months.
干预措施: N-acetylcysteine (Drug)
结局指标
主要结局
Change in tumor necrosis factor alpha (TNF-α)
时间窗: 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
时间窗: 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.
The change from baseline in (Total and Direct bilirubin)
时间窗: 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)
时间窗: 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.
次要结局
- Adverse events and toxicity(3 months.)
- 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.)
- Patients' symptoms, adverse events and toxicity(3 months.)
- 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.)
- 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.)
- 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)
研究者
Samah Hussein Mohamed
Master degree in Clinical Pharmacy
Tanta University