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IRCT20111105008013N8 IRCT 2020-01-26 Ahvaz University of Medical Sciences Investigating of Silybum marianum fruit extract on MS fatigue Study of effect of Silybum marianum fruit extract on fatigue in patients with multiple sclerosis: double blind, clinical trial 2020-01-10 anticipated 66 Complete https://irct.ir/trial/44864 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, the permuted block randomization will be used with quadruple blocks. blocks will be produced by using the online site (www.sealedenvelope.com), Blinding description: Unique codes, which is generated by the software, will be used on the drug boxes. By entering each individual into the study based on the produced sequence, the drug box in which the code is registered, will be assigned to the individual. During the research, the randomization list is held by the statistic consultant, and the participants, the project implementer and all those who participate in the measurement of the indicators will not be aware of the assigned groups. 2-3 Condition 1: Multiple sclerosis. Condition 2: Neurasthenia. Intervention 1: Intervention group: Interferon (main treatment) with Milk thistle capsules (420 mg daily) for one month. Intervention 2: Control group: Interferon (main treatment) with placebo capsules (three times a day) for one month. Yes - There is a plan to make this available What will be shared: Only a part of the data will be shared When: The access period will be 6 months after the publication of the results To whom: The information obtained will only be available to researchers working in universities and science centers Conditions: Six months after the publication of this study papers, the obtained data will be available to the applicant researchers for further analysis Where to obtain: Applicants can be contacted with corresponding author by e-mail How to obtain: Applicants will be able to access the obtained data from current study by sending an email to the corresponding author up to one month Comments:
public Amir Siahpoosh
Golestan road
Ahvaz Iran (Islamic Republic of) 6155883964 +98 61 3334 2197 Amirsiahpoosh@yahoo.com Ahvaz University of Medical Sciences scientific Amir Siahpoosh
Golestan road
Ahvaz Iran (Islamic Republic of) 6135733184 +98 61 3334 2197 Amirsiahpoosh@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Multiple sclerosis patients have fatigue Ages between 15-65 years old 15 years 65 years Both other neurological disease Diseases like diabetes and autoimmune diseases new attack in the last month New disease attack Pregnancy G35 F48.0 Multiple sclerosis Neurasthenia Treatment - Drugs Placebo Intervention group: Interferon (main treatment) with Milk thistle capsules (420 mg daily) for one month Control group: Interferon (main treatment) with placebo capsules (three times a day) for one month Fatigue. Timepoint: Start intervention and a month later. Method of measurement: MFIS questionnaire. Quality of Life. Timepoint: Start intervention and a month later. Method of measurement: MSQL-54 questionnaire. Side effects. Timepoint: One month after the intervention began. Method of measurement: Observation. Ahvaz University of Medical Sciences Approved 2018-12-22 Ahvaz Jundishapur University of Medical Sciences Golestan Road Ahvaz Khouzestan Iran (Islamic Republic of)