Diabetic Neuropathy. Polyneuropathy in diseases classified elsewhere
Conditions
Interventions
Intervention 1: Intervention group: Doxahexaenoic acid oral supplement containing 1000 mg of fish oil (500 mg of docosahexaenoic acid and 150 mg of eicosapentaenoic acid) manufactured by Karen Pharmac
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
45 Years to No maximum
Inclusion criteria
Inclusion criteria: Age of 45 and above Having diabetes based on WHO criteria (random plasma glucose =11·1 mmol/L, fasting plasma glucose =7·0 mmol/L, or 2-hour plasma glucose =11·1 mmol/L with oral glucose tolerance test) and based on the patient's record that has been in STABLE condition for at least three months (STABLE hypoglycemic drugs without insulin change +_20% and glycosylated hemoglobin [HbA1c] <9% at screening) Regular attendance at the hospital's outpatient clinic to ensure monitoring of blood sugar control and diabetes complications Documented clinical diagnosis of distal neuropathic pain based on pre-established criteria for peripheral neuropathy, neurological examination and EMG/NCV confirmed Experiencing neuropathic pain by scoring more than four in the Pain Diagnostic Questionnaire (DN4) or scoring more than 12 in the Self-reported Leeds Assessment of Neuropathic Symptoms and Signs (S -LANSS) for at least three months
Exclusion criteria
Exclusion criteria: Clinical evidence of severe or acute cardiovascular disease (heart attack or stroke in the past year) Atrial fibrillation or other cardiac arrhythmias Renal disease Cerebrovascular disease and any other systemic disease Allergy to omega-3 supplements or fish
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity. Timepoint: Pain intensity measurement at baseline (before intervention) and 12 weeks after intervention. Method of measurement: Visual Analogue Scale.;Functional status. Timepoint: Functional status measurement at baseline (before intervention) and 12 weeks after intervention. Method of measurement: Sheehan Disability Scale.;Serum nerve growth factor. Timepoint: Serum nerve growth factor measurement at baseline (before intervention) and 12 weeks after intervention. Method of measurement: Biochemical methods.;Serum uric Acid. Timepoint: Serum uric acid measurement at baseline (before intervention) and 12 weeks after intervention. Method of measurement: Biochemical methods.;Serum interleukin 6. Timepoint: Serum interleukin 6 measurement at baseline (before intervention) and 12 weeks after intervention. Method of measurement: Biochemical methods.;Serum interleukin 10. Timepoint: Serum interleukin 10 measurement at baseline (before intervention) and 12 weeks after intervention. Method of measurement: Biochemical methods. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life. Timepoint: Quality of life measurement at the beginning of the study (before the start of the intervention) and 12 weeks after the start of the intervention. Method of measurement: 36-item quality of life short form (sf-36). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSeyed Kazem Shakouri
Tabriz University of Medical Sciences
Outcome results
None listed