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IRCT138802201044N3 IRCT 2009-10-10 ParsRoos Company Neurotec in Symptomatic Diabetic Neuropathy Multi-Centre, Randomised, Double-Blind, Placebo Controlled Trial of the Effect of Neurotec in Symptomatic Diabetic Neuropathy 2009-10-10 anticipated 300 Complete https://irct.ir/trial/52 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 3 Diabetic Neuropathy. Intervention 1: Neurotec 120 mg (1 capsule) two times a day for 4 months and then 120 mg, 1 capsule a day for two month. Intervention 2: Gabapentin 300 mg (1 capsule) two times a day for 4 months and then 300 mg, 1 capsule a day for 2 months. Intervention 3: Placebo 1 identical capsule as active drug two times a day for 4 months and then 1 capsule a day for 2 months.
public Pezhman Madani
Shariati Hospital, North Kargar Ave.
Tehran Iran (Islamic Republic of) +98 21 8822 0088 pezhman@iums.ac.ir Endocrine and Metabolism research Center, Tehran University of Medical Sciences scientific Pezhman Madani
Shariati Hospital, North Kargar Ave.
Tehran Iran (Islamic Republic of) +98 21 8822 0088 pezhman@iums.ac.ir Endocrine and Metabolism Research center, Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion Criteria: Pain equivalent to 4 or more on a numerical scale between 0 and 10, Diagnosis of Diabetes Mellitus (Type 1 or 2) defined by American Diabetes Association criteria for at least 3 years, Haemoglobin A1C less than 10%, History of Diabetic Neuropathy for more than a year, Age more than 18 years and less than 60, diagnosis of neuropathy based on Michigan Neuropathy Screening Instrument Exclusion Criteria: Presence of uncontrolled or poor controlled DM, Presence of neuropathy due to other causes than DM, Receiving any investigational drug within 30 days prior to screening, Presence of active or infected diabetic wound, Amputation, Presence of any other systemic or chronic diseases such as: Myopathy, Vasculitis, Peripheral Vascular Diseases, Chronic hepatic or renal diseases, clinically complicating pulmonary, Cardiac, Hematologic, Gastrointestinal, Endocrine disease or Malignancy, Symptomatic degenerative joint disease, active radiculopathy or discopathy, spinal stenosis , active degenerative disc diseases, chronic sciatalgia, sacroiliac joint dysfunction or any chronic painful condition involving lower extremities, apparent or diagnosed psychological problem such as anxiety or depression, Diabetic Retinopathy or retinal haemorrhage, Pregnancy or intention of becoming pregnant during the study period (9 months), Inability to give informed consent according to the agreed process, Corticosteroid therapy, Any drug hypersensitivity, Radiotherapy, Chemotherapy or any immuosuppressive drug use, Electrolyte imbalance 18 years 60 years Both G63.2 Diabetic polyneuropathy Treatment - Drugs Treatment - Drugs Treatment - Drugs Neurotec 120 mg (1 capsule) two times a day for 4 months and then 120 mg, 1 capsule a day for two month Gabapentin 300 mg (1 capsule) two times a day for 4 months and then 300 mg, 1 capsule a day for 2 months Placebo 1 identical capsule as active drug two times a day for 4 months and then 1 capsule a day for 2 months Pain. Timepoint: Baseline, every other week during treatment period (6 months) and every month during follow-up period (3 months). Method of measurement: pain during the last 2 weeks prior to study visits through a Visual Alalogue Scale recorded daily by the patients in diary notebook. Severity of neuropathy. Timepoint: Baseline, every other week during treatment period (6 months) and every month during follow-up period (3 months). Method of measurement: Neuropathy symptom score. Nurve Conduction Velocity. Timepoint: Baseline, weeks 24 and 36. Method of measurement: Conduction velocity of tibial, proneal and sureal nerves. Monofilament test. Timepoint: Baseline, weeks 8, 16, 24 and 36. Method of measurement: Monofilament test. Existence and severity of peripheral neuropathy. Timepoint: Baseline, weeks 8, 16, 24 and 36. Method of measurement: Michigan Neuropathy Score. Patient's Global Impression of Change (PGIC). Timepoint: Baseline, every other week during treatment period and every month during follow-up period. Method of measurement: 10-point rating scale from very poor condition (1) to very good (10). Quality of life. Timepoint: Baseline, weeks 16, 24 and 36. Method of measurement: SF-12 questionnaire. Clinical Global Impression of Change (CGIC). Timepoint: Baseline, every other week during treatment period and every month during follow-up period. Method of measurement: 10-point rating scale from very poor condition (1) to very good (10) determined by the physician. ParsRoos Company Approved Ethic committee of Endocrinology and Metabolism Research Centre Fifth floor, Shariati hospital, North Kargar Ave., Tehran, Iran Tehran Iran (Islamic Republic of)