Melatonin for adults with systemic lupus erythematosus
Tests melatonin's effect on inflammation, sleep, fatigue and quality of life in adults with lupus.
Plain-language title generated from the registry record
Registry title: Effect of Melatonin Administration on Systemic Lupus Erythematosus Patients
Key facts
- Where
- Cairo, EgyptSee the site
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT07721324, who can take part
Where in Egypt
- Department of Rheumatology Ain Shams University hospitalsCairo, EgyptNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ain Shams University
- Trial code
- NCT07721324
- Record updated
- 23 July 2026
- Original description
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.Read full original descriptionShow less
Effect of Melatonin Administration on the Clinical Outcomes of 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: 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: Using sedations, antidepressants, contraceptives, antioxidant and/or omega-3-fatty acid supplements one month prior to or during the study; Any sleeping pills two weeks prior to the study; Other autoimmune diseases; Uncontrolled hypertension or Uncontrolled DM; Allergy to melatonin; Having active infectious diseases; Malabsorption syndromes; Malignancy; Stroke; 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; Severe hemolysis (reticulocyte count >8%); Severe thrombocytopenia (platelet count <40 000); Endocarditis; Lupus pneumonia; Alveolar hemorrhage; Smoking and/ or alcohol intake; Pregnancy, pregnancy plans and lactation; poor patient compliance; Warfarin or heparin use or high-dose aspirin (more than 325 mg/day).