Melatonin for people with diabetic peripheral neuropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults aged 40–75 with type 2 diabetes and diagnosed diabetic peripheral neuropathy will receive melatonin as an adjunct to their usual care and undergo laboratory and clinical testing during the treatment period. The study will measure oxidative stress markers, inflammatory cytokines (for example TNF‑alpha, IL‑1, IL‑6), and clinical neuropathy outcomes to determine biological and symptomatic effects. Participants must have stable antidiabetic medication and will be excluded for conditions such as autoimmune disease, severe liver or kidney dysfunction, neurodegenerative disease, active infection, recent antioxidant or anti‑inflammatory use, pregnancy, or melatonin allergy. The phase 2 interventional trial is conducted at Ain Shams University Hospital in Cairo.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients aged 40-75 years diagnosed with type 2 DM.
2. Diabetes duration at least 1 year.
3. Patients diagnosed with diabetic peripheral neuropathy.
4. Stable antidiabetic medication for at least 1 month before enrollment and during the trial

Exclusion Criteria:

1. Patients with autoimmune disorders (such as lupus and rheumatoid arthritis), thyroid diseases, peripheral arterial disease and cancer patients.
2. Patients with severe kidney or liver dysfunction.
3. Patients diagnosed with neurodegenerative diseases.
4. Active infection.
5. Use of medications or supplements known to cause or treat peripheral neuropathy.
6. Alcohol consumption or substance abuse.
7. Patients consuming any antioxidant supplements or anti-inflammatory medicines during or 3 months before enrollment.
8. Pregnancy or lactation or expecting to get pregnant during the study.
9. Allergy to melatonin.

Where it's running

• Ain Shams University hospital
  Cairo, Egypt Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.