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NCT07036796
Effect of Melatonin in Patients With Diabetic Peripheral Neuropathy
Conditions: Diabetic Peripheral Neuropathy, Diabetic Neuropathy, Diabetic Peripheral Neuropathy in Type 2 Diabetic Patients
Sex: All
Ages: 40 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 60
Sponsor: Ain Shams University
Location: Ain Shams University hospital Cairo
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.
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.
Source: ClinicalTrials.gov (NCT07036796). StuddyBuddy aggregates publicly available trial information.