]>
IRCT2016110330680N1 IRCT 2017-02-04 Vice chancellor for research, Shahed University Topiramate In Diabetic Polyneuropathy Evaluation Of Topiramate Efficacy On Neuropathic Pain In Patients With Diabetic Polyneuropathy 2008-12-31 anticipated 200 Complete https://irct.ir/trial/24297 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Patients who meet the criteria of study select by researchers assigned every other in intervention and control groups. Coworkers who are blind to group of patients or kind of drug evaluate the patients and finally patients complete the questionnaire. 2 Diabetic Polyneuropathy. Intervention 1: Group One(Intervention) All the selected patients are treated with Topiramate one hundred milligrams daily at night . Dose escalation is gradually over three weeks and patients are evaluated by VAS scale each two weeks for three months. Intervention 2: Group Two (control),All patients treat by Gabapentin nine hundred milligrams daily divided in three hundred milligram every eight hour. Pain intensity is measured every two weeks for twelve weeks by VAS scale.
public Siamak Afshin majd
Italia, ST. Keshavarz, Blvd.
Tehran Iran (Islamic Republic of) +98 21 8896 9438 afshin@shahed.ac.ir Associate Professor Of Neurology.Neurophysiology Research Center.Shahed University scientific Siamak Afshin majd
Italia ,ST. Keshavarz Blvd.
Tehran Iran (Islamic Republic of) +98 21 8896 9438 afshin@shahed.ac.ir Associate Professor Of Neurology, Neurophysiology Research Center, Shahed University Iran (Islamic Republic of) Inclusion criteria: Age between 35t0 75 years old; painful diabetic polyneuropathy; more than 8 year duration of disease; Exclusion criteria: Pain due to other cause; Taking any other pain killer drugs; History of allergy to drugs; Do not meet the criteria of ethical committee of shahed University; 35 years 75 years Both G63.2 Diabetic polyneuropathy (E10-E14 with common fourth character .4+) Treatment - Drugs Treatment - Drugs Group One(Intervention) All the selected patients are treated with Topiramate one hundred milligrams daily at night . Dose escalation is gradually over three weeks and patients are evaluated by VAS scale each two weeks for three months Group Two (control),All patients treat by Gabapentin nine hundred milligrams daily divided in three hundred milligram every eight hour. Pain intensity is measured every two weeks for twelve weeks by VAS scale. Pain In Diabetic Polyneuropathy. Timepoint: In the beginning of study and then every two weeks to three months. Method of measurement: Questionnaire Completed By Researchers And International Standard Scale Of (VAS). Drowsiness. Timepoint: Every two weeks. Method of measurement: Questionnaire Completed By researchers from patient complaints. Redness or pruritus of skin(hypersensitivity to drugs). Timepoint: Two weeks after starting the study and then every two weeks for twelve weeks. Method of measurement: Questionnaire completed By researchers and question from patients. Vice chancellor for research, Shahed University Approved 2007-10-16 Ethics Committee Of Shahed University Shahed University, Infront Of Emam Khomeini Tomb, Khalije Fars High Way Tehran Iran (Islamic Republic of)