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Sleep hormone melatonin put to the test against lupus fatigue and inflammation

NCT ID NCT07721324

Symptom relief Sponsor: Ain Shams University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This trial investigates whether taking melatonin before bed can improve sleep quality, reduce fatigue, and lower inflammation in adults with active lupus. Sixty-four participants will either receive standard care plus melatonin or standard care alone for 12 weeks. Researchers will measure changes in blood markers of inflammation and oxidative stress, as well as sleep and quality of life scores.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
melatonin, a hormone that regulates sleep, given as an oral tablet (15 mg/day) for 12 weeks
What this could lead to
If it works, melatonin could become a simple, low-cost way to improve sleep, reduce fatigue, and lower inflammation in people with lupus.
What could go wrong
This is a small, early-stage trial. Melatonin may not significantly affect lupus symptoms or inflammation, and side effects like drowsiness or dizziness are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 64 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Fatigue Inflammation systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Therapy Treatment

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Department of Rheumatology Ain Shams University hospitals

    Cairo, Egypt

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