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IRCT138705221044N1 IRCT 2008-09-05 Endocrine and Metablism research Centre Safety and efficacy of oral form of Neurotec in reduction of pain in patients with diabetic neuropathy Safety and efficacy of oral form of Neurotec in reduction of pain in patients with diabetic neuropathy, A phase II clinical trial 2008-08-01 anticipated 14 Complete https://irct.ir/trial/51 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Used, Assignment: Single, Purpose: Treatment. 2 Diabetic neuropathy. Oral form of drug Neurotec 120 mg capsules, 2 capsules a day for 16 weeks and 1 capsule a day for another 8 weeks.
public Ramin Heshmat
5th Floor, Shariati Hospital, North Karegar street,Tehran, Iran
Tehran Iran (Islamic Republic of) 14114 +98 21 8490 2786 pezhman@iums.ac.ir EMRC scientific pezhman madani
5th Floor, Shariati Hospital, Tehran, Iran
Tehran Iran (Islamic Republic of) 14114 +98 21 8490 2786 pezhman@iums.ac.ir EMRC Iran (Islamic Republic of) Inclusion criteria: having diabetic I or II having pain and paresthesia interfering with every day activities Diminished anckle reflex Abnormal 128 Hz vibration test Exclusion criteria: Unwilling to sign a written consent Non-diabetic neuropathy Wound infection or infection in extremities ischaemic heart disease Heart failure reeiving immunosuppresive drugs, corticosteroids, chemotherapy, radiotherapy Alcohol and substance misuse Electrolyte disturbances History of known hypersensitivity to drugs Haemodialysis 18 years 75 years Both Oral form of drug Neurotec 120 mg capsules, 2 capsules a day for 16 weeks and 1 capsule a day for another 8 weeks Pain measured by Visual Analogos Scale(VAS). Timepoint: baseline, 2, 4, 8, 12, 16 and 24 weeks. Method of measurement: measured by Visual Analogos Scale(VAS). Michigan Diabetic Neuropathy score. Timepoint: baseline, 2, 4, 8, 12, 16 and 24 weeks. Method of measurement: Questionaire. UK Diabetic Neuropathy score. Timepoint: baseline, 2, 4, 8, 12, 16 and 24 weeks. Method of measurement: Questionaire. Semmes-Weinstein monofilament test for peripheral sensory neuropathy. Timepoint: baseline, 2, 4, 8, 12, 16 and 24 weeks. Method of measurement: Monofilament test. ACTRN12608000388314 ANZCTR Endocrine and Metablism research Centre Approved Endocrine and Metablism research Centre Ethic committee 5th Floor, Shariati Hospital, North Karegar street, Tehran, Iran Tehran Iran (Islamic Republic of)