The aim of the current study is to evaluate the effect of melatonin administration on circulating levels of inflammatory mediators, oxidative stress, sleep quality, fatigue and quality of life in patients with SLE. To the best of our knowledge, this is the first randomized-controlled trial to evaluate the impact of melatonin on sleep quality and assess fatigue and quality of life in SLE adult patients. Moreover, the impact of melatonin on serum concentrations of Interleukin-6 and superoxide dismutase SOD will be evaluated.
Inclusion Criteria:
Exclusion Criteria:
Other autoimmune diseases
Uncontrolled hypertension or Uncontrolled DM
Severe renal (GFR < 30 ml/min ) or severe liver diseases (ALT or AST <3 times ULN or total bilirubin > 2 times ULN)
Life-threatening SLE including
Using sedations, antidepressants, contraceptives, antioxidant and/or omega-3-fatty acid supplements one month prior to or during the study
Smoking and/ or alcohol intake
Allergy to melatonin
Pregnancy, pregnancy plans and lactation.
Having active infectious diseases
poor patient compliance
Any sleeping pills two weeks prior to the study
Malabsorption syndromes
Malignancy
Warfarin or heparin use or high-dose aspirin (more than 325 mg/day)
Stroke
nirmeen.ms2324020@pharma.asu.edu.eg
32 patients will receive the standard of care treatment in addition to melatonin oral drug (15 mg/day) once daily for 12 weeks taken 30 minutes to 1 hour before bedtime.
32 patients will receive standard of care
areeg.mohamed@pharma.asu.edu.eg+201003152806
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Effect of Melatonin in Pediatric Hemodialysis Patients
Effect of Melatonin on Cardiovascular and Muscle Mass and Function in Patients With Heart Failure
Melatonin in Patients With Multiple Sclerosis (MS).
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Melatonin and the Metabolic Syndrome