Evaluation of the Effect of Direct-Acting Antiviral Agents on Melatonin Level in Chronic Hepatitis C Patients in Egypt.
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- Change in malondialdehyde (MDA) level.
研究概览
简要总结
Patients with hepatitis c showed increased level of oxidative stress. Increased level of serum lipid peroxidation leads to the production of toxic mediators as malondialdehyde (MDA) which lead to disease progression. Chronic stress shunt tryptophan which is essential amino acid toward kynurenic pathway leading to lower level of serotonin and melatonin level. Currently, direct-acting antivirals (DAAs) show well-established efficacy against hepatitis C virus (HCV).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic hepatitis C patients had no other cause of liver disease
排除标准
- •Patients with hepatitis B virus (HBV).
- •Patients with acute hepatitis.
- •Patients with renal insufficiency.
- •Patients with Hepatocellular carcinoma (HCC) or other types of malignancy.
- •Patients on current use of melatonin.
- •Patients using of any of medications that have interaction with melatonin.
- •Patients work in night shifts.
- •Patients are consuming a lot of caffeine or heavy smokers.
研究组 & 干预措施
sofosbuvir/daclatasvir treated group (group 2)
干预措施: Direct Acting Antivirals (Drug)
sofosbuvir /daclatasvir/ ribavirin treated group (group 3)
干预措施: Direct Acting Antivirals (Drug)
结局指标
主要结局
Change in malondialdehyde (MDA) level.
时间窗: 12 weeks following end of treatment.
Malondialdehyde (MDA) levels will be measured by the TBARS assay (thiobarbituric acid reactive substance assay)
Change in melatonin level.
时间窗: 12 weeks following end of treatment.
Melatonin will be measured by using immunological method.
次要结局
未报告次要终点
研究者
Heba Mohammed Hashem Ali
Assistant lecturer
Tanta University