Effect of Melatonin in Patients With Diabetic Peripheral Neuropathy
Recruiting · NCT07036796 · Interventional (participants receive a specific treatment) · Lead sponsor: Ain Shams University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
Age range
40 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
- Pregnancy or lactation or expecting to get pregnant during the study.
- Allergy to melatonin.
Where it is running
1 location listed.
- Ain Shams University hospital - Cairo, Egypt