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IRCT20180404039187N5 IRCT 2019-09-05 Tabriz University of Medical Sciences Evaluation of the effect of memantine on diabetic neuralgia(diabetic nouropathy)(DN) The study of efficacy of memantin on nouropathy in diabetic patients-double blind randomized clinical trial 2019-05-15 anticipated 100 Complete https://irct.ir/trial/40841 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Arrangement of the randomization process: 1) Determining the volume of each block (quadruple blocks) 2) Preparing the list of the blocks and assigning a number to each of them AABB(1) ABAB(2) ABBA(3) BBAA(4) BABA(5) BAAB(6) 3) Choosing random numbers between 1 and 6 4) Defining the treatment assignment list For example: AABB(1)_BBAA(4)_ABAB(2)_BABA(5), Blinding description: The participants (patients) and the researcher who have the task of sampling in the study are all blind during the study. At the patient's level, blindness will be done as the patients do not know in which group (control or intervention group) they are in. The researcher on the basis of lable A or B without knowing the nature of A, B and according to the randomized list will give the medicine to pateints or not. 2-3 diabetic nouropathy. Intervention 1: Intervention group: received memantine 5 mg twice daily in the first week and received memantine 10 mg from week 2 to week 8 twice daily. Intervention 2: Control group: routin care which includes Cap Gabapentin 300 mg once daily at night. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I have no definitive decision
public Elnaz Shaseb
Faculty of Pharmacy, Tabriz university of Medical Science, Golgaste Ave., Azadi Ave.
Tabriz Iran (Islamic Republic of) 5166614766 +98 144933344198 Elnaz_shaseb_64@yahoo.com Tabriz University of Medical Sciences scientific Elnaz Shaseb
Faculty of Pharmacy, Tabriz university of Medical Science, Golgaste Ave., Azadi Ave.
Tabriz Iran (Islamic Republic of) 5166614766 +98 144933344198 Elnaz_shaseb_64@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients with diabetic neuropathy (PDN) aged between 18 and 75 years who have been diagnosed with PDN due to physical examinations. And patients treated with gababirzin (gabapentin and pregabalin) 18 years 75 years Both Pregnancy- Lactation- Cardiovascular disease- The presence of other neuropathies, such as neuropathy caused by herpes and trigeminal neuralgia, and ...- Sensitization to memantine or other formulation components- Uncontrolled hypertention- Epilepcy- Liver failure- Renal insufficiency with creatinine clearance less than 30 ml / min E11.42 Type 2 diabetes mellitus with diabetic polyneuropathy Treatment - Drugs Diagnosis Intervention group: received memantine 5 mg twice daily in the first week and received memantine 10 mg from week 2 to week 8 twice daily Control group: routin care which includes Cap Gabapentin 300 mg once daily at night. Fasting blood sugar level. Timepoint: At the beginning and 3 months after intervention. Method of measurement: Enzymatic method with Pars Azmoon kit. Glycosylated hemoglobin (three months sugar)(A1C). Timepoint: At the beginning and 3 months after intervention. Method of measurement: Immunoturbidimetryَ autoanalyzers assay. Heat and cold test. Timepoint: At the beginning and 3 months later. Method of measurement: Using a thermophile tool (Diagnostic Tool for Neuropathy). Diapazon test. Timepoint: At the beginning and 3 months later. Method of measurement: Using Diapazone (Diagnostic Tool for Neuropathy). Monofilament. Timepoint: At the beginning and 3 months later. Method of measurement: Using a monofilament device (a diagnostic tool for neuropathy). Pain and numbness on the soles of the feet and hands. Timepoint: At the beginning and 3 months later. Method of measurement: DN4 questionnaire. Tabriz University of Medical Sciences Approved 2019-06-11 Ethics Committee of Tabriz University of Medical Sciences Research & Technology Dept, Central Building No. 2, Third Floor, Tabriz University of Medical Sciences, Golghast St, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)