Diabetic neuropathy. Type 2 diabetes mellitus with diabetic neuropathy, unspecified
Conditions
Interventions
Intervention 1: Intervention group: Pregabalin 75 mg every 12 hours and agomelatine 25 mg every night for 8 weeks. Intervention 2: Control group: Pregabalin 75 mg every 12 hours and placebo every nigh
Sponsors
Hamedan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Age 18 to 70 years Type 2 diabetes for at least one year Diabetic neuropathy
Exclusion criteria
Exclusion criteria: Pregnancy or breastfeeding The presence of wounds and infections in the leg Cerebrovascular diseases and discopathy Consumption of alcohol or opioids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average pain score. Timepoint: Before the intervention and in the second, fourth and eighth weeks after the intervention. Method of measurement: Using the visual analog scale (VAS).;The average sleep disorder score. Timepoint: Before the intervention and in the second, fourth and eighth weeks after the intervention. Method of measurement: Using a standard sleep disorder questionnaire.;Average serum level of hemoglobin A1c. Timepoint: Before the intervention and in the second, fourth and eighth weeks after the intervention. Method of measurement: By taking blood samples.;The average recovery score of patients. Timepoint: Before the intervention and in the second, fourth and eighth weeks after the intervention. Method of measurement: Using the Patient Global Impression of Change (PGIC) questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNastaran Ahmadi Moghadam
Hamedan University of Medical Sciences
Outcome results
None listed