TherapyPhase 2/3SLENCT07721324
Effect of Melatonin Administration on Systemic Lupus Erythematosus Patients
A Phase 2/3 study testing Melatonin in people with Therapy and Treatment, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- What is being tested?
- Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Jul 2026to 21 Nov 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Department of Rheumatology Ain Shams University hospitals
Cairo
Nirmeen Amr Habib Nirmeen Amr, +201124147642, nirmeen.ms2324020@pharma.asu.edu.eg
Areej Mohamed Atya Lecturer, PhD, +201003152806, areeg.mohamed@pharma.asu.edu.eg
About this study
Official title: 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.
Read the detailed description
Systemic lupus erythematosus (SLE) is a multisystem chronic autoimmune disease with a relapsing and remitting course. Its prevalence is higher in women of childbearing age of non-white ethnicity. It has a broad spectrum of clinical features ranging from mild cutaneous involvement to severe organ damage, such as kidney failure, pulmonary hypertension, and cardiac failure. The exact etiology of the disease is not well understood well. However, inflammation and oxidative stress are among the most important targets for the management of SLE. Elevated circulating IL-6 concentrations have been consistently observed in patients with systemic lupus erythematosus (SLE) relative to healthy controls, underscoring its pathogenic relevance. In systemic lupus erythematosus (SLE), excessive oxidative stress arising from chronic inflammation and immune complex deposition leads to depletion of endogenous antioxidants, including SOD.
Moreover, diminished SOD activity correlates with disease activity indices such as SLEDAI, suggesting its potential utility as a biomarker for oxidative stress-related disease burden.
melatonin has anti-inflammatory and anti-oxidant characteristics that may aid in the management of autoimmune diseases. In different animal models, melatonin has demonstrated to ameliorate lupus nephritis, reduce inflammation, and improve overall disease pathology. However, these studies have their limitations of being performed in vitro.Only one randomized controlled trial (RCT) was conducted on adult SLE patients and showed improvement in oxidative stress markers, namely malondialdehyde and total antioxidant capacity but no effect on disease activity.
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.
- Being tested
- Melatonin
- Keywords
- Melatonin, Systemic Lupus Erythematosus, Inflammation, Fatigue, SLEQoL
- Medical subject headings
- Lupus Erythematosus, Systemic, Inflammation, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Melatonin group | Experimental | 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. Receives: Drug: Melatonin |
| Control group: | No intervention | 32 patients will receive standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Interleukin- 6 (IL-6)
Blood samples will be drawn from the patients at baseline and after 12 weeks of intervention. Blood samples will be collected at baseline, centrifuged and stored as serum at - 80°C or -20°C until analysis. Enzyme-linked immunosorbent assay (ELISA) method will be used to measure Interleukin 6 concentrations
Measured: at baseline and then after 12 weeks
Secondary outcomes (6)
SLEDAI -2K Score
A)Items: It includes 24 items, with 16 clinical and 8 laboratory-based descriptors.
B)Domains: The items are grouped into nine organ systems: central nervous system, vascular, musculoskeletal, serosal, dermal, constitutional, renal, immunological, and hematological.
C)Scoring: Each item is scored as present or absent, typically based on the preceding 30 days.
D)Total Score: The individual item scores are summed to produce a global score, ranging from 0 to 105.
Measured: at baseline and then after 12 weeks
Serum SOD
Superoxide dismutase (SOD) measured by Spectrophotometric Method, by tracking the inhibition of superoxide radical-driven reactions, often involving the reduction of nitro blue tetrazolium (NBT) or the autoxidation of other compounds like BXT-01050, which produce a color change that is measured at a specific wavelength, typically around 525 nm or 560-562 nm. The rate of this color change in the presence of a sample is compared to the rate in a blank, with the percent inhibition of the reaction directly correlating to the amount of SOD present in the sample.
Measured: at baseline and after 12 weeks
Arabic version form of Systemic Lupus Erythematosus-Specific Quality of Life Questionnaire (SLEQOL-Arabic Version)
The questionnaire consists of 40 items covering multiple domains relevant to SLE. These items are grouped into 6 domains which are:
- Physical functioning / mobility
- Role limitation / daily activities
- Self-image / appearance
- Emotional / mood
- Symptoms 6_Social / interpersonal relations Each of the 40 items is rated using a 7-point Likert scale (1=Not at all affected and 7=Extremely affected). Higher scores generally reflect poorer QoL.
Measured: at baseline -1st Month-2nd Month-3rd Month
Arabic version of Fatigue Severity Scale (FSS)
FSS is a self-reported questionnaire that is simple and easy to use. It consists of 9 statements that rate the severity of the patient's fatigue symptoms in terms of how these symptoms affect motivation, exercise, physical function, and activities of daily living Reflecting on their condition over the past month, patients score each item from 1 to 7, based on the extent, to which they agree or disagree with each statement (1 = strong disagreement, 7 = strong agreement).
Measured: at baseline -1st Month-2nd Month-3rd Month
Arabic Version of the Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. Each weighed equally on a O-3 scale. The seven component scores are then summed to yield a global PSQI score, which has a range of O-2 I; higher scores indicate worse sleep quality.
Measured: at baseline- 1st Month-2nd Month-3rd Month
Incidence of Adverse Effects and Medication Adherence & Modifications
All patients in both arms will be followed weekly by a telephone call for reporting of any adverse effects from melatonin and patients will be given a side effect-reporting card and will be educated on how to use it. Moreover, compliance to medications and any change of doses or addition or discontinuation of medications will be assessed.
Measured: weekly up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start21 Jul 2026 (estimated)
- Primary completion21 Oct 2026 (estimated)
- Study completion21 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TherapyStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nirmeen amr habib, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07721324
- Sponsor's protocol ID
- RHDIRB2020110301 REC # 444
- Acronym
- SLE
- Status last verified
- Jul 2026
- First submitted
- 18 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Melatonin Administration on the Clinical Outcomes of Systemic Lupus Erythematosus Patients
- ClinicalTrials.gov ID
- NCT07721324
- Acronym / sponsor ID
- SLE / RHDIRB2020110301 REC # 444
- Keywords
- Melatonin, Systemic Lupus Erythematosus, Inflammation, Fatigue, SLEQoL
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 21 Jul 2026 (estimated)
- Primary completion
- 21 Oct 2026 (estimated)
- Study completion
- 21 Nov 2026 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Systemic lupus erythematosus (SLE) is a multisystem chronic autoimmune disease with a relapsing and remitting course. Its prevalence is higher in women of childbearing age of non-white ethnicity. It has a broad spectrum of clinical features ranging from mild cutaneous involvement to severe organ damage, such as kidney failure, pulmonary hypertension, and cardiac failure. The exact etiology of the disease is not well understood well. However, inflammation and oxidative stress are among the most important targets for the management of SLE. Elevated circulating IL-6 concentrations have been consistently observed in patients with systemic lupus erythematosus (SLE) relative to healthy controls, underscoring its pathogenic relevance. In systemic lupus erythematosus (SLE), excessive oxidative stress arising from chronic inflammation and immune complex deposition leads to depletion of endogenous antioxidants, including SOD.
Moreover, diminished SOD activity correlates with disease activity indices such as SLEDAI, suggesting its potential utility as a biomarker for oxidative stress-related disease burden.
melatonin has anti-inflammatory and anti-oxidant characteristics that may aid in the management of autoimmune diseases. In different animal models, melatonin has demonstrated to ameliorate lupus nephritis, reduce inflammation, and improve overall disease pathology. However, these studies have their limitations of being performed in vitro.Only one randomized controlled trial (RCT) was conducted on adult SLE patients and showed improvement in oxidative stress markers, namely malondialdehyde and total antioxidant capacity but no effect on disease activity.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin group | Experimental | Drug: Melatonin32 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. |
| Control group: | No intervention | –32 patients will receive standard of care |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- 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
- Using sedations, antidepressants, contraceptives, antioxidant and/or omega-3-fatty acid supplements one month prior to or during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin32 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. | Drug | Melatonin group |
Primary outcome
Serum Interleukin- 6 (IL-6)
Time frame: at baseline and then after 12 weeks
Blood samples will be drawn from the patients at baseline and after 12 weeks of intervention. Blood samples will be collected at baseline, centrifuged and stored as serum at - 80°C or -20°C until analysis. Enzyme-linked immunosorbent assay (ELISA) method will be used to measure Interleukin 6 concentrations
6 secondary outcomes
SLEDAI -2K Score
Time frame: at baseline and then after 12 weeks
Serum SOD
Time frame: at baseline and after 12 weeks
Arabic version form of Systemic Lupus Erythematosus-Specific Quality of Life Questionnaire (SLEQOL-Arabic Version)
Time frame: at baseline -1st Month-2nd Month-3rd Month
Arabic version of Fatigue Severity Scale (FSS)
Time frame: at baseline -1st Month-2nd Month-3rd Month
Arabic Version of the Pittsburgh Sleep Quality Index (PSQI)
Time frame: at baseline- 1st Month-2nd Month-3rd Month
Incidence of Adverse Effects and Medication Adherence & Modifications
Time frame: weekly up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Melatonin in people with Therapy and Treatment, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nirmeen A. Habib, Master (+201124147642, nirmeen.ms2324020@pharma.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Interleukin- 6 (IL-6) (time frame: at baseline and then after 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.