Effect of Melatonin Administration on Systemic Lupus Erythematosus Patients

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: * Adult male and female patients with active SLE aged 18-60 years * Active SLE patients defined on SLEDAI-2K score to be (more than or equal 4 up to 11) according to the classification of SLE as suggested by the American Rheumatology Association (American College of Rheumatology) * Have had non-life-threatening disease * Taking stable doses of medications for SLE treatment in the last three months * Ability and willingness to cooperate in the study Exclusion Criteria: * Other autoimmune diseases * Uncontrolled hypertension or Uncontrolled DM * Severe renal (GFR \< 30 ml/min ) or severe liver diseases (ALT or AST \ 2 times ULN) * Life-threatening SLE including * Severe hemolysis (reticulocyte count \>8%) * Severe thrombocytopenia (platelet count \