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IRCT20260105068551N1 IRCT 2026-01-29 Ghoum University of Medical Sciences The effect of duloxetine and bupropion on neuropathic pain in diabetic neuropathy Comparison of the efficacy of duloxetine and bupropion in reducing neuropathic pain due to diabetic neuropathy: a randomized triple-blind clinical trial 2026-01-29 anticipated 300 Complete https://irct.ir/trial/88750 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The study is designed as a triple-blind, randomized clinical trial with three parallel groups, and the unit of randomization is individual patients. Eligible participants are randomly assigned to one of the three groups. The random sequence was generated using Random Allocation Software with fixed-size blocks of 6 or 9 patients per block to ensure balanced group sizes. No stratified randomization was used in this study. For allocation concealment, the randomization codes were placed in sealed, numbered envelopes, accessible only to the responsible pharmacist. Patients, evaluating physicians, and data analysts are blinded to group assignments, ensuring that the study is conducted in a triple-blind manner, Blinding description: In this study, the active drugs and placebos are identical in appearance, color, size, packaging, and administration, allowing for participant-level blinding. The trial is conducted as a triple-blind study, meaning that participants, evaluating physicians and clinical care staff, and data analysts are unaware of the group assignments. The pharmacist responsible for dispensing the medications is the only individual with access to the randomization codes, and no other research team members are informed of patient allocation. This approach ensures unbiased data collection, outcome assessment, and result analysis. The Data Safety and Monitoring Committee and the team preparing manuscripts also have no access to group assignments. It should be noted that participants are not informed of their assigned group, solely to maintain blinding, and this is conducted in full compliance with ethical standards and informed consent requirements. 3 neuropathic pain. 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 reputable domestic pharmaceutical companies, and the appearance and packaging are identical to placebos. Patients, physicians, and data analysts are blinded to group allocation. Intervention 2: Intervention group: Patients receive standard diabetes treatment plus oral duloxetine 60 mg daily for 4 weeks, along with bupropion placebo. Medications are obtained from reputable domestic pharmaceutical companies, and the appearance and packaging are identical to placebos. Patients, physicians, and data analysts are blinded to group allocation. Intervention 3: Control group: Patients receive only standard diabetes treatment and routine care, along with bupropion placebo and duloxetine placebo. Medications and placebos are identical in appearance and packaging, obtained from reputable domestic pharmaceutical companies. Patients, physicians, and data analysts are blinded to group allocation. Yes - There is a plan to make this available What will be shared: De-identified individual participant data (IPD) related to the primary and secondary outcomes of the clinical trial: "Determining the effect of Duloxetine in reducing neuropathic pain compared to Bupropion". When: Data will become available 6 months after the publication of the primary results of the trial and will remain accessible for a period of 5 years. To whom: Access will be granted to researchers affiliated with academic or scientific institutions who provide a methodologically sound research proposal. Access for commercial or for-profit entities is not permitted. Conditions: The data can only be used for the purpose of conducting individual participant data meta-analysis, reanalysis for validation, or other scientifically approved questions as outlined in the approved research proposal. All users must sign a Data Use Agreement committing to: 1) Not attempting to re-identify participants, 2) Securely storing the data, 3) Not transferring the data to third parties, 4) Acknowledging the original study in any publications, and 5) Destroying the data after the completion of their analysis. Where to obtain: All requests must be sent via email to the principal investigator of the study (drmaryamamini6771@yahoo.com) and should include the research proposal and the requester’s institutional affiliation details. The principal investigator and holder of the study is Ms. Maryam Mirzaamini How to obtain: Submission of a formal request via email. 2. Initial review by the PI for completeness. 3. Evaluation of the scientific merit and objectives by a designated data access committee (DAC) within 4 weeks. 4. If approved, preparation and execution of the Data Use Agreement. 5. Secure transfer of de-identified data in a common format (e.g., .csv, .sav). The entire process is expected to take 6 to 8 weeks from initial request to data transfer. Comments: The study protocol, statistical analysis plan (SAP), and analytic code will be made publicly available on a recognized repository (e.g., ClinicalTrials.gov or OSF) upon completion of participant enrollment.
public Maryam sadat Mirzaamini
Shahid sadoqhi streat 39.no83
Qom Iran (Islamic Republic of) 3716993456 +98 25 3292 4067 maryamamini9846@gmail.com Ghoum University of Medical Sciences scientific Maryam sadat Mirzaamini
Shahid sadoqhi streat 39.no83
Qom Iran (Islamic Republic of) 3716993456 +98 25 3292 4067 maryamamini9846@gmail.com Ghoum University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both 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 G63.2 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. Treatment - Drugs Treatment - Drugs Treatment - Drugs 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 reputable domestic pharmaceutical companies, and the appearance and packaging are identical to placebos. Patients, physicians, and data analysts are blinded to group allocation Intervention group: Patients receive standard diabetes treatment plus oral duloxetine 60 mg daily for 4 weeks, along with bupropion placebo. Medications are obtained from reputable domestic pharmaceutical companies, and the appearance and packaging are identical to placebos. Patients, physicians, and data analysts are blinded to group allocation Control group: Patients receive only standard diabetes treatment and routine care, along with bupropion placebo and duloxetine placebo. Medications and placebos are identical in appearance and packaging, obtained from reputable domestic pharmaceutical companies. Patients, physicians, and data analysts are blinded to group allocation 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. 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. Ghoum University of Medical Sciences Approved 2025-08-18 Ethics Committee of Qom University of Medical Sciences Chamran Street, Shahid Beheshti Hospital Qom Ghoum Iran (Islamic Republic of)