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NOT YET RECRUITING
NCT07721324
PHASE2/PHASE3

Effect of Melatonin Administration on Systemic Lupus Erythematosus Patients

Sponsor: Ain Shams University

View on ClinicalTrials.gov

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

DRUG

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