]>
IRCT20230303057599N2 IRCT 2023-07-13 Tehran University of Medical Sciences The effect of alpha lipoic acid on neuropathy in patients with type 2 diabetes Investigating the effect of alpha lipoic acid on neuropathy in patients with type 2 diabetes. 2023-08-01 anticipated 80 Complete https://irct.ir/trial/70428 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Patients are consecutively entered into the study and if there are entry criteria and consent to entry, they are allocated to each of the intervention or control groups by random block. The intervention group receives capsules of 300 mg of alpha lipoic acid and the control group receives capsules with the same shape and design, without medicinal substances, Randomization description: Blocks of 4 and 6 will be used for randomization in order to assign patients individually and with equal numbers to intervention and control groups. Random allocation software can also be used. patient's allocation group after consultation and consent. Opaque sealed envelopes will be used to conceal allocations, Blinding description: In this study, the research samples are not aware of which drug or placebo they are receiving. Also, the prescribing doctor is not aware of the drug. Only the principal investigator will know whether A or B is drug or placebo. Also, the data analyst will not know which data are for the intervention group and which are for the control group. Medicines are ordered in the form of capsules with the same color, shape and weight for both groups, and it will not be possible for the patient and the prescribing doctor to distinguish them. 3 Diabetes - type 2. Intervention 1: Intervention group: This group will receive 300 mg capsules of alphalipoic acid (Raha Pharmaceutical Company) twice a day. In order to receive the capsule, the necessary educational explanations are given by the doctor to both the intervention and control groups. Also, all the drugs used by the patients in both groups will be recorded. In addition, these patients have routine tests of CBC, blood sugar, etc. The patients will be given medicine for one month and at the end of the first, second and third month they will be examined. Also, information is obtained from the patients' compliance with alphalipoic acid medication. Patients only know that they are under research and have consented to enter the study, but they are not aware of receiving drugs or placebo. Intervention 2: Control group: After obtaining consent following the review of entry criteria, the patients assigned to the control group will receive a placebo(Raha Pharmaceutical Company) instead of alphalipoic acid capsules, which the patients and the prescribing doctor do not know whether it is a drug or a placebo. The patients will receive the medicine for one month and will return every month, and the intervention group will receive all the training and examinations from the prescribing doctor. Also, the patient will be asked about the consumption of capsules. Medications taken by the patient are also checked and recorded during the course. Yes - There is a plan to make this available What will be shared: To share the data, all the data after deidentification in the form of excel or spss files regarding all the desired consequences can be provided to the officials of the ministry to help in developing the protocol. Also, researchers can get the file after the request from the link that will be designed. When: Access starts three months after the publication of the article To whom: Hospital managers and doctors with permission from the principal investigator Conditions: For the purpose of secondary analysis on the data by presenting the approved design code Where to obtain: Dr. Mahdi Shafiee Sabet mshafiees@sina.tums.ac.ir How to obtain: The request can be made in writing and officially by the registration in the automation system, etc. to the main researcher Comments:
public Mahdi Shafiee Sabet
Qala Morghi St. - Abu Dhar St., District 17 Municipality
Tehran Iran (Islamic Republic of) 1366736511 +98 21 5575 1333 mshafiees@sina.tums.ac.ir Tehran University of Medical Sciences scientific Mahdi Shafiee Sabet
Qala Morghi St. - Abu Dhar St., District 17 Municipality
Tehran Iran (Islamic Republic of) 1366736511 +98 21 5575 1333 mshafiees@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age 18 to 74 years, Type 2 diabetes, duration of diabetes more than one year, presence of peripheral neuropathy (pain) in the examination, symptoms of neuropathy (pain) for at least one month, score more than three in the pain diagnostic questionnaire. 18 years 74 years Both neurological disease such as MS Severe liver or kidney disease Antioxidant consumption in the last three months The presence of cancer and malignancy and chemotherapy Pregnancy and breastfeeding Peripheral arterial disease diabetic foot ulcer E08.40 Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified Treatment - Drugs Treatment - Drugs Intervention group: This group will receive 300 mg capsules of alphalipoic acid (Raha Pharmaceutical Company) twice a day. In order to receive the capsule, the necessary educational explanations are given by the doctor to both the intervention and control groups. Also, all the drugs used by the patients in both groups will be recorded. In addition, these patients have routine tests of CBC, blood sugar, etc. The patients will be given medicine for one month and at the end of the first, second and third month they will be examined. Also, information is obtained from the patients' compliance with alphalipoic acid medication. Patients only know that they are under research and have consented to enter the study, but they are not aware of receiving drugs or placebo. Control group: After obtaining consent following the review of entry criteria, the patients assigned to the control group will receive a placebo(Raha Pharmaceutical Company) instead of alphalipoic acid capsules, which the patients and the prescribing doctor do not know whether it is a drug or a placebo. The patients will receive the medicine for one month and will return every month, and the intervention group will receive all the training and examinations from the prescribing doctor. Also, the patient will be asked about the consumption of capsules. Medications taken by the patient are also checked and recorded during the course Neuropathy. Timepoint: At the beginning of the study and then once a month until the completion of the probationary period. Method of measurement: Physical examination. Pain. Timepoint: At the beginning of the study and then once a month until the completion of the probationary period. Method of measurement: visual analog scale for pain. Tehran University of Medical Sciences Approved 2021-08-14 School of Medicine - Tehran University of Medical Sciences (Research Ethics Committee) Poorsina Tehran Tehran Iran (Islamic Republic of)