Evaluation of the Effect of Direct-Acting Antiviral Agents on Melatonin Level in Chronic Hepatitis C Patients in Egypt.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Tanta University
- Enrollment
- 50
- Primary Endpoint
- Change in malondialdehyde (MDA) level.
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •chronic hepatitis C patients had no other cause of liver disease
Exclusion Criteria
- •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.
Arms & Interventions
sofosbuvir/daclatasvir treated group (group 2)
Intervention: Direct Acting Antivirals (Drug)
sofosbuvir /daclatasvir/ ribavirin treated group (group 3)
Intervention: Direct Acting Antivirals (Drug)
Outcomes
Primary Outcomes
Change in malondialdehyde (MDA) level.
Time Frame: 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.
Time Frame: 12 weeks following end of treatment.
Melatonin will be measured by using immunological method.
Secondary Outcomes
No secondary outcomes reported
Investigators
Heba Mohammed Hashem Ali
Assistant lecturer
Tanta University