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IRCT20211106052983N1 IRCT 2022-01-14 Yasouj University of Medical Sciences The effect of oral Clonidine on the treatment of diabetic neuropathy. The effect of oral Clonidine on the symptoms of peripheral neuropathy in diabetic patient. Randomized clinical trial. 2022-01-16 anticipated 70 Complete https://irct.ir/trial/59958 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: They will be randomly divided into experimental and control groups. Randomization is by envelops or Cards shuffling method. In this method, a number of cards selected by the researcher as the first group and the same number of cards for the next groups are considered; Then, by merging the cards with each other, a card is picked up and its allocation is recorded, and that card is returned to the total of the other cards. The cards are then merged again and another card is picked up. This process continues until a random sequence is reached according to the sample size. Also, the number of cards is not necessarily equal to the total number of samples. For example, in a three-group study with a sample size of 300 people and a ratio of 1: 1 groups, 3 cards can be prepared for each group, Blinding description: The researcher performs clinical examination and registers information without knowing the group of patients. 2-3 Diabet- Diabetic neuropathy.. Intervention 1: Intervention group: Patients with diabetic neuropathy will be treated with Gabapentin 100 mg every night and clonidine 0.2 mg every morning. Intervention 2: Control group: Patients with diabetic neuropathy will be treated with gabapentin 100 mg capsule every night. Yes - There is a plan to make this available What will be shared: The spss data file includes groups, main variables and demographic variables When: After publishing the article extracted from the plan To whom: Those who have corresponded with the responsible author and have the necessary reason to receive the file Conditions: We have not made a decision in this case and a decision will be made after reviewing the request Where to obtain: Seyed Majid Ahmadi How to obtain: The applicant should send his request via email and after obtaining permission from all project partners, if the partners agree with his request, the data will be sent to him. Comments:
public Soraya Bagheri
No. 1 dormitory complex in front of Imam Sajjad Hospital, Saheli Street
Yasuj Iran (Islamic Republic of) 7591683677 +98 74 3323 3707 psyhosein67@gmail.com Yasouj University of Medical Sciences scientific Seyed Majid Ahmadi
Yasuj, Montazeri Street, in front of the electricity office
Yasuj Iran (Islamic Republic of) 7591738841 +98 74 3322 3645 majidahmadi1385@yahoo.com Yasouj University of Medical Sciences Iran (Islamic Republic of) Patients with type 2 diabetes who have symptoms associated with peripheral neuropathy. No chronic illness (cardiovascular, renal and thyroid disorders), severe neurology or psychiatry. Do not be pregnant or breastfeeding. Not taking medications that are effective in exacerbating or alleviating neuropathy. Age between 30 and 60 years old. 30 years 60 years Both Having severe sensitivity to Clonidine Having neuropathy with proven reasons except Diabetes E11.40 Type 2 diabetes mellitus with diabetic neuropathy, unspecified. Treatment - Drugs Treatment - Drugs Intervention group: Patients with diabetic neuropathy will be treated with Gabapentin 100 mg every night and clonidine 0.2 mg every morning Control group: Patients with diabetic neuropathy will be treated with gabapentin 100 mg capsule every night. Severity of neuropathy in this study based on the Michigan Questionnaire, pain based on the McGill Pain Questionnaire. Timepoint: Before the start of the study and 14, 28, 56 days later. Method of measurement: The Michigan Questionnaire, the McGill Questionnaire, and the researcher-designed questionnaire. Yasouj University of Medical Sciences Approved 2021-04-08 Ethics Committee of Yasouj University of Medical Sciences No. 1, First floor dormitory complex, Saheli Street, in front of Imam Sajjad Hospital. Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)