Effect of Melatonin in Patients With Diabetic Peripheral Neuropathy (NCT07036796) | Clinical Trial Compass
RecruitingPhase 2
Effect of Melatonin in Patients With Diabetic Peripheral Neuropathy
Egypt60 participantsStarted 2025-07-04
Plain-language summary
The aim of the current study is to measure the effect of melatonin as adjunct therapy on oxidative stress, inflammatory markers and clinical outcome in type 2 diabetic patients with diabetic peripheral neuropathy.
Who can participate
Age range
40 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients aged 40-75 years diagnosed with type 2 DM.
. Diabetes duration at least 1 year.
. Patients diagnosed with diabetic peripheral neuropathy.
. Stable antidiabetic medication for at least 1 month before enrollment and during the trial
Exclusion criteria
. Patients with autoimmune disorders (such as lupus and rheumatoid arthritis), thyroid diseases, peripheral arterial disease and cancer patients.
. Patients with severe kidney or liver dysfunction.
. Patients diagnosed with neurodegenerative diseases.
. Active infection.
. Use of medications or supplements known to cause or treat peripheral neuropathy.
. Alcohol consumption or substance abuse.
. Patients consuming any antioxidant supplements or anti-inflammatory medicines during or 3 months before enrollment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Concentration of human nuclear factor erythroid 2-related factor (Nrf2)
Timeframe: Change from baseline human Nuclear factor erythroid 2-related factor at 3 months.