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IRCT20241129063892N1 IRCT 2024-12-08 Mazandaran University of Medical Sciences Effect of Oral Caffeine on Fatigue in Multiple Sclerosis Patients The Effects of Oral Caffeine on Fatigue in Multiple Sclerosis Patients: A Randomized Double Blind Clinical Trial 2024-12-14 anticipated 60 Complete https://irct.ir/trial/80599 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Single, Purpose: Treatment, Randomization description: Random allocation of patients into the caffeine and placebo groups will be performed using the method of randomized blocks. It should be noted that the block size will be determined completely randomly to ensure the allocation of the last participant in each block. According to the aforementioned protocol, a total of 60 patients (30 in each group) will be enrolled in the study and assessed for the outcomes of caffeine consumption. For example, suppose the first randomly generated block consists of four participants with the following sequence: A for the intervention group and B for the control group: A B B A In this case, the first participant will be assigned to the intervention group, the second and third to the control group, and the fourth to the intervention group. Subsequent blocks will be generated with random sizes, and this process will continue until all 60 patients are allocated to the two groups. It is worth mentioning that the intervention and control groups will be matched for variables such as age, gender, weight, and height. After matching and determining the blocks, participants will be numbered sequentially upon enrollment. Group allocation within each block will be determined using the Random Allocation Software version 2, and the codes will be placed in numbered envelopes. For each patient, the corresponding envelope will be opened, and the assigned intervention will be implemented, Blinding description: Given the study design, the drug and placebo will be prepared in identical packaging in terms of size and color and will be numbered based on the randomization table. Both the patients and the clinical physicians conducting the study, as well as those involved in data collection and chart review, will remain blinded to the group allocation of the participants. This ensures a double-blind design. 3 Fatigue in multiple sclerosis. Intervention 1: Intervention group: Administration of 200 mg caffeine tablets (manufactured by Eurho Vital),at a dose of half a tablet (equivalent to 100 mg) once a day, for a duration of three months. Intervention 2: Control group: Administration of placebo tablets, at a dose of half a tablet once a day, for a duration of three months. Yes - There is a plan to make this available What will be shared: Demographic information, questionnaire data, and details related to the primary outcome will be shared after anonymizing the individuals. When: The access period will commence six months after the publication of the results. To whom: Researchers affiliated with academic and scientific institutions will be granted access to the data. Conditions: For scientific and research purposes Where to obtain: To obtain the documentation, please send your request to the project manager, Dr. Mohammad Baghbanian, at Mohammadbaghbanian@gmail.com. How to obtain: After submitting the request, the necessary evaluations will be conducted, and the results will be sent to the applicant’s email address. Comments:
public Aida gharanjig
Bu-Ali Sina hospital,Pasdaran Blvd
Sari Iran (Islamic Republic of) 4815838477 +98 911 424 9771 A.gharanjik93@gmail.com Mazandaran University of Medical Sciences scientific Mohammad Baghbanian
Bu-Ali Sina Hospital, Pasdaran Blvd
Sari Iran (Islamic Republic of) ۴۸۱۵۸۳۸۴۷۷ +98 911 151 8209 Mohammadbaghbanian@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Adult patients aged 18 years and older diagnosed with multiple sclerosis Obtaining informed consent. Having a fatigue score (MFIS) greater than 33. 18 years no limit Both Diagnosis of depression Anemia Hypothyroidism Hypertension Cardiac arrhythmias Caffeine sensitivity Concurrent use of medications affecting fatigue Lack of consent to participate or continue in the study Irregular medication use or non-adherence to the study schedule History of using medications containing caffeine. Pregnancy Recent caffeine consumption within the past week. Treatment - Drugs Placebo Intervention group: Administration of 200 mg caffeine tablets (manufactured by Eurho Vital),at a dose of half a tablet (equivalent to 100 mg) once a day, for a duration of three months. Control group: Administration of placebo tablets, at a dose of half a tablet once a day, for a duration of three months. Fatigue score in the Modified Fatigue Impact Scale (MFIS) questionnaire. Timepoint: At the beginning of the study and three months after caffeine consumption. Method of measurement: Modified Fatigue Impact Scale questionnaire. Mazandaran University of Medical Sciences Approved 2024-10-01 Ethics committee of Mazandaran University of Medical Sciences Research and Technology Vice-Chancellor’s Building, Moallem Square Sari Mazandaran Iran (Islamic Republic of)