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Effect of Melatonin Administration on Systemic Lupus Erythematosus Patients
Sponsor: Ain Shams University
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.
Official title: Effect of Melatonin Administration on the Clinical Outcomes of Systemic Lupus Erythematosus Patients
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
64
Start Date
2026-07-21
Completion Date
2026-11-21
Last Updated
2026-07-23
Healthy Volunteers
No
Interventions
Melatonin
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.
Locations (1)
Department of Rheumatology Ain Shams University hospitals
Cairo, Egypt