Effect of Melatonin in Patients With Diabetic Peripheral Neuropathy

Launched by AIN SHAMS UNIVERSITY · Jun 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether melatonin, a natural hormone that helps regulate sleep, can improve symptoms and reduce inflammation and stress in people with diabetic peripheral neuropathy. This condition is a common complication of type 2 diabetes that causes nerve damage, often leading to pain, tingling, or numbness in the hands and feet. The researchers want to see if adding melatonin to the usual diabetes treatment can help protect nerves and improve how patients feel.

The study is looking for adults between 40 and 75 years old who have had type 2 diabetes for at least one year and have been diagnosed with diabetic peripheral neuropathy. Participants need to be on stable diabetes medication and not taking other supplements or medicines that affect nerve health. People with certain other health problems, such as autoimmune diseases, severe kidney or liver issues, or pregnancy, won’t be eligible. If you join the study, you can expect to take melatonin alongside your current treatment while doctors monitor your symptoms and certain health markers to see if melatonin makes a difference. This trial is not yet recruiting, but it aims to find new ways to help manage diabetic nerve pain safely and effectively.

Gender

ALL

Eligibility criteria

• 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.