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IRCT20230520058232N1 IRCT 2023-06-26 Sanandaj University of Medical Sciences Effect of pyridostigmine in stroke-related dysphagia Investigating the effect of Pyridostigmine to improving dysphagia in stroke patients 2023-07-23 anticipated 60 Complete https://irct.ir/trial/70315 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of randomization in this study was based on the block randomization method. Blocking was usually used in order to balance the number of samples assigned to each of the studied groups. This feature helps the researchers to have the same number of samples assigned to each of the studied groups in cases where intermediate analyzes are needed during the sampling process.Blocking was done in two ways. In the first method, the size of all the blocks is equal (for example, in a two-group trial, there are 8 blocks including 4 participants in the intervention group and 4 participants in the control group), and in the second method, the size of the blocks was chosen randomly (for example , blocks of 6, 8, 10 and 14) in which there is an equal number of each group in each block.In this study, the samples are selected using random selection from four randomized blocks. The four randomized blocks selected are AABB, ABAB, ABBA, BBAA, BABA, BAAB (A: patients receiving pyridostigmine and B: patients receiving placebo), Blinding description: Patients who participate in the project based on informed consent do not know whether they belong to the intervention or control group. Due to the nature of the intervention and the method of study design, only the specialist doctor of the plan is aware of the type of treatment. Other doctors who perform examinations and examinations of patients at the beginning and in subsequent visits, will be unaware of the patient's belonging to the intervention or control group. Also, the statistician does not know the identity of the patients, and the researcher who collects the information of the patients collects the information only through a numerical list that does not contain the names of the patients. 3 Stroke related dysphagia. Intervention 1: Intervention group: receiving pyridostigmine 120 mg every 12 hours for three weeks. Intervention 2: Control group: receiving placebo every 12 hours for three weeks. Yes - There is a plan to make this available What will be shared: Non-identifiable individual data and related dictionaries are prepared in the form of checklists that can be made available to other researchers after the end of the study and publication of its results. In addition, relevant additional documents such as study protocol, data analysis plan, etc. will also be shared. The informed consent form and clinical study report are also shareable. When: Start of access period after publication of study results To whom: The study data and other documents will be accessible to researchers, including those employed in academic and scientific institutions, individuals working in industry, etc., after publication of the study results Conditions: Given the non-disclosure of patients' personal data, the use of documents and conducting analysis on them is authorized Where to obtain: Applicants can request the desired documents or data from the trial's executor by sending a message to fkarimian1363@gmail.com via email or by corresponding with the executor at the sampling location's postal address How to obtain: The requester mentions their request via the email mentioned, and it will be addressed as soon as possible Comments:
public Farzaneh Karimian
Kurdistan University of Medical Sciences, across from Shadi Hotel, Pasdaran Street
Sanandaj Iran (Islamic Republic of) 1344666177 +98 87 1613 1311 fkarimian1363@gmail.com Sanandaj University of Medical Sciences scientific Farzaneh Karimian
Kurdistan University of Medical Sciences, across from Shadi Hotel, Pasdaran Street
Sanandaj Iran (Islamic Republic of) 1344666177 +98 87 1613 1311 fkarimian1363@gmail.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) Confirming the diagnosis of stroke disease based on imaging and laboratory results GCS level of consciousness greater than 12 Age above 18 years old 18 years no limit Both Age less than 18 years hemorrhagic stroke head and/or neck trauma I69.391 Dysphagia following cerebral infarction Treatment - Drugs Placebo Intervention group: receiving pyridostigmine 120 mg every 12 hours for three weeks Control group: receiving placebo every 12 hours for three weeks Severity of patients' dysphagia based on the score of Swallowing Disturbance Questionnaire (SDQ). Timepoint: Measuring the score of the questionnaire in patients at the beginning of the study and after the start of treatment until 14 days after the end of treatment. Method of measurement: Swallowing Disturbance Questionnaire. Sanandaj University of Medical Sciences Approved 2022-06-25 Ethics Committee of Kurdistan University of Medical Sciences Kurdistan University of Medical Sciences, across from Shadi Hotel, Pasdaran Street Sanandaj Kurdistan Iran (Islamic Republic of)