Effect of Melatonin Administration on Systemic Lupus Erythematosus Patients (NCT07721324) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
Effect of Melatonin Administration on Systemic Lupus Erythematosus Patients
Egypt64 participantsStarted 2026-07-21
Plain-language summary
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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \<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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.