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IRCT20200128046288N5 IRCT 2020-11-19 Ahvaz University of Medical Sciences Effect of Jadwar capsules in multiple sclerosis patients Clinical evaluation of the effect of Jadwar (Delphinium denudatum) capsules on quality of life and fatigue of multiple sclerosis patients 2020-12-21 anticipated 60 Complete https://irct.ir/trial/52171 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The block randomization method is used. Because we have two intervention groups, equal 4 blocks is used and all 4 possible modes is created and then with Excel software we randomly select a number of blocks. Label of the medications is one of the letters A or B and the sequence of randomization determined by the statistical consultant. For allocation concealment, drug delivery and the sequence of randomization is not performed by researchers and evaluators while is the responsibility of another individual , Blinding description: Unique codes, which is generated by the software, will be used on the drug and placebo boxes. By entering each individual into the study based on the produced sequence, the drug or placebo box in which the code is registered, are 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 are not aware of the assigned groups. 2-3 Condition 1: Multiple sclerosis. Condition 2: Fatigue. Intervention 1: Intervention group: Capsule of Jadwar 500 mg once daily for three months. Intervention 2: Control group: Capsule of placebo once daily for three months. Yes - There is a plan to make this available What will be shared: Only part of the data will be shared When: The access time is up to 6 months after the results are published To whom: Six months after the publication of articles from this study, the data obtained will be made available to the applicant researchers for further analysis Conditions: Six months after the publication of articles from this study, the data obtained will be made available to the applicant researchers for further analysis. Where to obtain: Applicants can email the responsible author to receive the requested data golfakhrabadi@yahoo.com How to obtain: Applicants will have access to the data from the present study by emailing the responsible author for up to one month. golfakhrabadi@yahoo.com Comments:
public Fereshteh Golfakhrabadi
Ahvaz Jundishapur University of Medical Sciences, Golestan street
Ahvaz Iran (Islamic Republic of) 6135733184 +98 61 3373 8378 golfakhrabadi@yahoo.com Ahvaz University of Medical Sciences scientific Fereshteh Golfakhrabadi
Ahvaz Jundishapur University of Medical Sciences, Golestan street
Ahvaz Iran (Islamic Republic of) 6135733184 +98 61 3373 8378 golfakhrabadi@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) MS has been proven by clinical examinations and medical history Having stable and regular drug treatment in the last 4 weeks No new attack in last month Having a score of EDSS disability assessment between 2 to 5.5 15 years 65 years Both Pregnancy and lactation Renal and hepatic dysfunction Neurologic disease in addition to MS Cardiovascular disease or infectious disease Allergy to Jadwar G35 F48.0 Multiple sclerosis Fatigue Treatment - Drugs Placebo Intervention group: Capsule of Jadwar 500 mg once daily for three months Control group: Capsule of placebo once daily for three months Fatigue rate. Timepoint: The first day of intervention and three months later. Method of measurement: FSS questionnaires. Quality of Life. Timepoint: The first day of intervention and three months later. Method of measurement: Questionnaire MSQL54. Side effects of the drug. Timepoint: Three months after the start of the intervention. Method of measurement: Observation. Ahvaz University of Medical Sciences Approved 2020-10-31 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Ahvaz Jundishapur University of Medical Sciences,, Golestan street Ahvaz Khouzestan Iran (Islamic Republic of)