neuropathic pain. Diabetic polyneuropathy is a type of neuropathy that results from chronic diabetes, causing damage to the peripheral nerves. It often affects the feet and legs, but can also impact other body areas.
Conditions
Interventions
Intervention 1: Intervention group: Patients receive standard diabetes treatment plus oral bupropion 75 mg every 12 hours for 4 weeks, along with duloxetine placebo. Medications are obtained from repu
Sponsors
Ghoum University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age 18 years or older Confirmed diagnosis of type 1 or type 2 diabetes mellitus based on medical records Clinically diagnosed symptomatic diabetic peripheral neuropathy with neuropathic pain confirmed by a specialist physician History of neuropathic pain related to diabetic neuropathy for at least 3 months Neuropathic pain intensity of at least 4 out of 10 based on the VAS scale during the previous week Receiving stable standard treatment for diabetes for at least 4 weeks prior to enrollment Ability to understand the study procedures and provide written informed consent Negative pregnancy test in women of childbearing potential and use of effective contraception
Exclusion criteria
Exclusion criteria: Presence of known causes of peripheral neuropathy other than diabetes History of hypersensitivity or intolerance to duloxetine or bupropion History of seizure disorders or eating disorders such as anorexia nervosa or bulimia nervosa Severe hepatic disease or severe renal impairment Presence of unstable systemic diseases that may interfere with safe participation in the study Severe and uncontrolled psychiatric disorders Concurrent use of medications specifically indicated for neuropathic pain within the past 14 days Active alcohol or substance abuse Pregnancy or breastfeeding Participation in another clinical trial within the past 30 days Inability or unwillingness to comply with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean score of diabetic neuropathic pain intensity based on the Visual Analogue Scale. Timepoint: Measurement at baseline (before the start of intervention), at the end of week 4 after treatment initiation, and at 3 months (12 weeks) after treatment initiation. Method of measurement: Using the standard 100-mm Visual Analogue Scale. Patients will mark their perceived pain intensity on a 100-mm horizontal line, where the left endpoint (0 mm) is labeled "no pain" and the right endpoint (100 mm) is labeled "the worst pain imaginable." The score is the distance in millimeters from the left endpoint.;Mean score of paresthesia severity (tingling/burning sensation) based on the Visual Analogue Scale. Timepoint: Measurement at baseline (before the start of intervention), at the end of week 4 after treatment initiation, and at 3 months (12 weeks) after treatment initiation. Method of measurement: Using the standard 100-mm Visual Analogue Scale. Patients will mark the severity of their tingling/burning sensation on a 100-mm horizontal line, where the left endpoint (0 mm) is labeled "no paresthesia" and the right endpoint (100 mm) is labeled "the most severe paresthesia imaginable." The score is the distance in millimeters from the left endpoint. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of medication adherence. Timepoint: Assessment at the end of week 4 and at 3 months (12 weeks) after treatment initiation. Method of measurement: Using a combination of pill count and patient self-report via a medication diary. Adherence rate will be calculated using the formula: [(Number of pills dispensed - Number of pills returned) / Number of pills prescribed] × 100. An adherence rate of 80% or higher will be considered acceptable.;Mean score of health-related quality of life. Timepoint: Assessment at baseline (before the start of intervention) and at 3 months (12 weeks) after treatment initiation. Method of measurement: Using the validated Persian version of the Short Form-36 Health Survey questionnaire. This standard instrument consists of 36 items across eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Scores for each domain range from 0 to 100, with higher scores indicating better health status.;Incidence of treatment-related adverse events. Timepoint: Monitoring and recording throughout the study period from the start of intervention until the final visit at 3 months (12 weeks). Systematic inquiry will be conducted at each follow-up visit (week 4 and month 3). Method of measurement: Through direct questioning of participants, open-ended inquiry, and clinical examination at each visit. All reported or observed adverse events will be recorded in a standardized Case Report Form, detailing the event description, time of onset, severity (graded as mild, moderate, or severe), duration, action taken regarding the study drug, and outcome. Causality to the study drug (duloxetine or bupropion) will be assessed by the investigator. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMaryam sadat Mirzaamini
Ghoum University of Medical Sciences
Outcome results
None listed