Effect of Melatonin in Patients With Diabetic Peripheral Neuropathy
Recruiting
Phase 2Interventional Study
Diabetic Peripheral NeuropathyDiabetic NeuropathyDiabetic Peripheral Neuropathy in Type 2 Diabetic Patients
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
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At a Glance
Age
40 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Ain Shams University · Other
Who this trial is looking for
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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.
Trial Locations
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Status
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…
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.
Contacts
No contact information available.
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