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IRCT20210216050383N1 IRCT 2021-02-21 Iran University of Medical Sciences Effect of pyridostigmine in post-stroke dysphagia Evaluation of the therapeutic effect of pyridostigmine in post-stroke dysphagia 2021-02-18 anticipated 24 Complete https://irct.ir/trial/54396 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: This study is currently a pilot study, Randomization description: We use block size 4 randomization with equal probability for eligible patients to enter groups A and B. According to Block Size 4, we have six possible combinations for assigning individuals to groups, including AABB, ABAB, BAAB, BABA, BBAA and ABBA. At the beginning of the study, we randomly select one of these arrangements and four eligible patients are placed on each block, respectively. We repeat this process several times until all eligible patients are examined. Randomization Tool: Random Numbers Table Randomization is concealed in an sealed envelope, Blinding description: Patients who participate in the project based on informed consent do not know their belonging to the intervention or control group. Due to the nature of the intervention and the design method of the study, only the specialist physician in the course of the treatment is aware of the intervention. Other physicians and speech pathologist who perform examinations of the patients at the beginning and in subsequent referrals 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 patients' information only collects the information through a numerical list in which the patients' names are not available. 1-2 Dysphagia following cerebral infarction. Intervention 1: Intervention group:Tablet Pyridostigmine 60 mg TDS before each meals for one month. Intervention 2: Control group: a Placebo tablet one before each meal (three times a day) for one month. Yes - There is a plan to make this available What will be shared: Unidentifiable data of individuals and related dictionaries are prepared as checklists that can be provided to other researchers after the study is finished and the results are published. Additional documents such as study protocol, data analysis program, etc. will also be shared. Also, the informed consent form and clinical study report can be shared. When: Starting access period after publishing the study results To whom: After publishing the results of the study, the data and other documents of the study are for researchers, including employed in academic and scientific institutions and people who are engaged in the industry, will be accessible. Conditions: Due to the lack of the patients' personal data, the use of documentation and analysis on it is permitted. Where to obtain: Applicants can send a message to the trial plan's executor via email enssieh.hashemi@gmail.com or communicate with the executor via correspondence with the postal address of the sampling location. How to obtain: The requester of these documents or data files will list their request by email and the request will be processed as soon as possible. Comments:
public Seyedeh Enssieh Hashemi
No.3, plate No.6, Khodajoo Alley, Ekhtiarieh jonubi Ave, Pasdaran Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 1958646863 +98 21 2256 3192 enssieh.hashemi@gmail.com Iran University of Medical Sciences scientific Seyedeh Enssieh Hashemi
No.3, plate No.6, Khodajoo Alley, Ekhtiarieh jonubi Ave, Pasdaran Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 1958646863 +98 21 2256 3192 enssieh.hashemi@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Patients with ischemic stroke revealed by CT scan or MRI 14 to 180 days before intervention and diagnosed to have post-stroke dysphagia according to MASA score(more than 177) and PSR time(more than 1.5 s) assessed by a speech pathologist. 18 years no limit Both Younger than 18 Hemorrhagic stroke Stroke onset before 14 days or after 180 days Head and/or neck injuries I69.391 Dysphagia following cerebral infarction Treatment - Drugs Placebo Intervention group:Tablet Pyridostigmine 60 mg TDS before each meals for one month Control group: a Placebo tablet one before each meal (three times a day) for one month Grade of patients dysphagia according to Mann Assessment of Swallowing Ability score sheet. Timepoint: Measuring the score of Mann Assessment of Swallowing Ability questionnaire in patients at the beginning of the study (before the intervention) and 30 days after the use of pyridostigmine. Method of measurement: Mann Assessment of Swallowing Ability questionnaire. Pharyngeal swallowing Reflex time. Timepoint: Measurement of pharyngeal swallowing reflex time in patients at the beginning of the study (before the intervention) and 30 days after the use of pyridostigmine. Method of measurement: Assessed by Speech pathologist bedside. Iran University of Medical Sciences Approved 2020-12-26 Research Ethics committee of Iran University of Medical Sciences No.3, plate No. 6, Khodajoo Alley, South Ekhtiarieh Ave, Pasdaran Ave Tehran Tehran Iran (Islamic Republic of)