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IRCT20191030045277N2 IRCT 2020-10-15 Babol University of Medical Sciences The effect of nortriptyline and melatonin on diabetic neuropathy Comparison of the effect of nortriptyline and melatonin on the severity of diabetic polyneuropathy 2019-12-22 anticipated 60 Complete https://irct.ir/trial/43358 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using the random block method with block size 4 (AABB) and the number of blocks 15, patients will be randomly divided into two groups. According to www.randomization.com, Block of 4 will be produced 15 times. To group patients, it will be written on a sheet and assigned to patients. Each patient will be randomly assigned to one of the treatment groups (nortriptyline and melatonin) while receiving the drug, according to the sequence obtained, Blinding description: Melatonin and nortriptyline will be prepared in identical opaque capsules and will be placed in exactly the same cans and packages, and the coding will be done according to a random table. None of the participants, principal investigator, health care personnel (physicians, nurses, etc.) will be responsible for patient care (etc.), data collectors and statistical analysts, will not be aware of patient received package and the coding. 2-3 Condition 1: Diabetic polyneuropathy. Condition 2: Diabetic polyneuropathy. Intervention 1: Intervention group : Patients in this group will be treated with nortriptyline 25 mg (Sobhan Pharmaceutical Company). Its duration will be 35 days. Intervention 2: Intervention group: Patients in this group will be treated with 3 mg melatonin (Razak Pharmaceutical Company) daily.Its duration will be 35 days. Yes - There is a plan to make this available What will be shared: A portion of the data related to the main topic is displayed. When: Start of access period 6 months after printing result. To whom: It will only be available to researchers working in academic and scientific institutions Conditions: No special conditions Where to obtain: Babol University of Medical Sciences, Internal Education, Dr. Mohammad Ali Bayani How to obtain: Refer to internal training and talk to Dr. Bayani and access to information Comments:
public Mohammadali Bayani
Ganj Afrooz Road, Babol Rohani Hospital
Babol Iran (Islamic Republic of) 47176-47745 +98 11 3223 8309 bayanima49@yahoo.com Babol University of Medical Sciences scientific Mohammadali Bayani
Ganj Afrooz Road, Babol Rohani Hospital
Babol Iran (Islamic Republic of) 47176-47745 +98 11 3223 8309 bayanima49@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) All patients with diabetic neuropathy 30 years 65 years Both Pregnancy and lactation Recent Myocardial Infarction Sensitivity to medications (nortriptyline and melatonin) History of seizures Mood disorder Gastroparesis and diabetic cystopathy, Liver and Renal failure hypothyroidism and hyperthyroidism people with arthritis Hereditary neuropathies People with a history of trauma and degenerative bone lesions E10.42 E11.42 Type 1 diabetes mellitus with diabetic polyneuropathy Type 2 diabetes mellitus with diabetic polyneuropathy Treatment - Drugs Treatment - Drugs Intervention group : Patients in this group will be treated with nortriptyline 25 mg (Sobhan Pharmaceutical Company). Its duration will be 35 days. Intervention group: Patients in this group will be treated with 3 mg melatonin (Razak Pharmaceutical Company) daily.Its duration will be 35 days. Severity of neuropathy. Timepoint: At the beginning of the study (first day) and at the end of the second week and at the end of the study (end of the fifth week). Method of measurement: Based on the VAS (Visual Analogue Scale). Babol University of Medical Sciences Approved 2020-01-18 Ethics committee of Babol University of Medical Sciences Ganjafruze road, Babol town Babol Mazandaran Iran (Islamic Republic of)