NCT07721324Not yet recruitingPhase 2/3
Effect of Melatonin Administration on Systemic Lupus Erythematosus Patients
Effect of Melatonin Administration on the Clinical Outcomes of Systemic Lupus Erythematosus Patients
Source: ClinicalTrials.gov · Last updated 23 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- First submitted
- 18 Jul 2026
- Start date
- 21 Jul 2026
- Primary completion date
- 21 Oct 2026
- Lead sponsor
- Ain Shams University
- Diseases
- Lupus (SLE)
- NCT number
- NCT07721324
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 64
- From 21 Jul 2026 to the primary completion date, 21 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 illness
- Other autoimmune diseases
- Uncontrolled hypertension or Uncontrolled DM
- Allergy to melatonin
- Having active infectious diseases
- Malabsorption syndromes
- Malignancy
- Stroke
Lab values
- 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
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Rheumatology Ain Shams University hospitals Coordinator of this site? Confirm its status | Cairo | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.