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IRCT20190618043934N24 IRCT 2024-03-02 Birjand University of Medical Sciences Evaluation of the effect of vitamin B12 on neuropathy in diabetic patients of Razi Hospital in Birjand in 2023 Investigating the effect of vitamin B12 on the neuropathy of diabetic patients 2024-02-04 anticipated 80 Complete https://irct.ir/trial/75015 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The placement of people in each group will be simple random and in a block method, in one of two control groups A: receiving routine neuropathy drugs and intervention group B: group receiving routine drugs + vitamin B12 divided daily 1000 micrograms will be One of these blocks will be randomly selected using the lottery method and the patients will be divided into one of two groups A or B. Then randomization is done for other patients as well. This will be done by the secretary, Blinding description: Outcome evaluator: The study leader (4th year neurology assistant) examines the symptoms of neuropathy at the beginning and end of the study without knowing the patients' placement in the drug group. The data analyst also does not know the placement of the patients and the type of drug they will receive, they will be blind. 3 Diabetic neuropathy. Intervention 1: Intervention group: Recipients of routine neuropathy drugs, patients who have taken the above drugs for 3 months, and before and after the intervention (3 months after taking the drug), the relevant parameters are evaluated. Intervention 2: Intervention group: The second intervention group: the group receiving routine drugs + vitamin B12 in the form of 1000 micrograms daily, the patients took the above drugs for 3 months, and before and after the intervention (3 months after taking the drug), the relevant parameters were evaluated. 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 There is no need to publish individual patient information
public Dr Meysam Javadi
School of Medicine, Birjand University of medical sciences, Ghahhari Blvd, Birjand, South Khorasan, Iran.
Birjand Iran (Islamic Republic of) 9717934888 +98 56 3238 1500 oabstudent@gmail.com Birjand University of Medical Sciences scientific Dr Hamidreza Riasee
Department of Neurology, School of Medicine, Birjand University of medical sciences, Ghahhari Blvd, Birjand Town
Birjand Iran (Islamic Republic of) 9717811674 +98 56 3236 6000 oabstudent@gmail.com Birjand University of Medical Sciences Iran (Islamic Republic of) Patient satisfaction to enter the study Having diabetes for more than a year no limit no limit Both Having an underlying disease such as myositis Having connective tissue and joint disease Limb amputation Having autoimmune disease Having severe osteoarthritis Malignancy Having fibromyalgia Having kidney and liver failure Patients with ESRD Prolonged diabetes Having vertebral discopathy Having anemia Having hypothyroidism Drug use E08.43 Diabetes mellitus due to underlying condition with diabetic autonomic (poly)neuropathy Treatment - Drugs Treatment - Drugs Intervention group: Recipients of routine neuropathy drugs, patients who have taken the above drugs for 3 months, and before and after the intervention (3 months after taking the drug), the relevant parameters are evaluated. Intervention group: The second intervention group: the group receiving routine drugs + vitamin B12 in the form of 1000 micrograms daily, the patients took the above drugs for 3 months, and before and after the intervention (3 months after taking the drug), the relevant parameters were evaluated. Pain. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Using the audio-visual pain scale questionnaire. Symptoms and severity of neuropathy. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: By Using Nerve conduction velocity. Birjand University of Medical Sciences Approved 2023-11-27 Ethics Committee of Birjand University of Medical Sciences Vice Chancellor for Research and Technology, Birjand University of Medical Sciences, Ghaffari Blvd, Birjand, South Khorasan, Iran. Birjand South Khorasan Iran (Islamic Republic of)