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IRCT20201020049089N1 IRCT 2020-12-15 Iran University of Medical Sciences Evaluating the effect of bumetanide on ALS ALS Evaluating the effect of bometanide on spasticity in patients with ALS 2020-12-21 anticipated 25 Complete https://irct.ir/trial/51745 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Randomization description: In this study, ALS patients referred to the medical center were randomly divided into two groups of bometanid and placebo using a randomized block design with two blind strains in a ratio of 1: 1. All the identity and medical information of the participants in the two groups will be covered on all the researchers until the end of the study and statistical analysis of the study results, Blinding description: All participants and their caregivers, clinicians, researcher and data analysts will be blinded to treatment assignments until final data analysis. 2-3 Amyotrophic lateral sclerosis. Intervention 1: Intervention group: In this group, ALS patients will be treated with bometanid at a dose of 2 mg every 12 hours as an oral tablet for 3 months. Intervention 2: Control group: In this group, ALS patients will be treated with placebo for 3 months, which is completely similar to bometanide in terms of appearance such as shape and color and will be taken orally every 12 hours. Yes - There is a plan to make this available What will be shared: All information about the results of the drug intervention on the participants can be shared after making individuals unidentified. When: 1 year after the publication of the article To whom: Researchers working in academic and scientific institutions Conditions: Conditions for access to study data is to use in clinical and research studies in affiliated centers. Where to obtain: Faculty of Advance Technologies in Medicine. Department of Neuroscience. Dr. Mohammad Taghi Joghtaei (Department Manager) How to obtain: Access to the data requires approval from the Vice President for Research and the Ethics Committee. Comments:
public Mohammad Taghi Jogharaei
Hemmat gighway
Tehran Iran (Islamic Republic of) 1449614535 86704837 mt.joghataei@yahoo.com Iran University of Medical Sciences scientific Mohammad Taghi Joghataei
Hemmat highway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8862 2687 mt.joghataei@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) 1. No history of other neurological diseases such as stroke and dementia 2. No orthopedic problems 3. Not having diabetes. addiction. hepatitis 4. The patient's education level at least up to the fifth grade 18 years 80 years Both 1. Lack of cooperation of the patient during testing and exercises 2. Failure to refer the patient for the second stage tests after the interventions 3. Patients whose diet is changed. G12.21 Amyotrophic lateral sclerosis Treatment - Drugs Treatment - Drugs Intervention group: In this group, ALS patients will be treated with bometanid at a dose of 2 mg every 12 hours as an oral tablet for 3 months. Control group: In this group, ALS patients will be treated with placebo for 3 months, which is completely similar to bometanide in terms of appearance such as shape and color and will be taken orally every 12 hours. MUNIX and ALSFRS-R. Timepoint: Before and after intervention. Method of measurement: ALSFRS-R questionnaire and electromyogram device. Iran University of Medical Sciences Approved 2020-11-22 Ethics committee of Iran University of Medical Sciences Hemmat highway Tehran Tehran Iran (Islamic Republic of)