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IRCT20140617018126N6 IRCT 2022-11-01 Tabriz University of Medical Sciences The effect of Flaxseed and Nigella Sativa on MS The effect of hydroalcoholic extracts of Flaxseed (seed of Linum usitatissimum) and Nigella Sativa plants on fatigue in MS patients 2021-11-22 anticipated 50 Complete https://irct.ir/trial/66482 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples will be randomly assigned to six blocks using Random Allocation Software. Blocking and allocation sequences for concealment will be done by the non-involved researcher (Allocation Concealment). The sample allocation ratio will be Allocation 1:1 and will be divided into two groups of receiving Flaxseed and Nigella Sativa, and Placebo. Then based on blocks and allocation sequences, each client will be given white pockets that are prepared in equal sizes and on which the numbers 1 to 50 are written (in order of allocation sequence). The pockets will contain white boxes containing Flaxseed, Nigella Sativa, or Placebo soft gels. Only the person in charge of packing drugs will know the numbers of the relevant pockets and none of the researchers or patients will know the type of medicine each person receives. The first person will be given pocket number 1, which will continue until completion. soft gels will be similar in shape, size, color, and, smell, Blinding description: Based on blocks and allocation sequences each client will be given white pockets that are prepared in equal sizes and on which the numbers 1 to 50 are written (in order of allocation sequence). The pockets will contain white boxes containing Flaxseed and Nigella Sativa, or Placebo capsules. Only the person in charge of packing soft gels will know the numbers of the relevant pockets and none of the researchers or patients will know the type of medicine each person receives. The first person will be given pocket number 1, which will continue until completion. All soft gels will be similar in shape, size, color, and smell. 2 Fatigue of MS patients. Intervention 1: Intervention group: This group will receive a capsule containing 0.75 ml Flaxseed and 0.75 ml Nigella Sativa soft gels every 12 hours and for 3 months. The capsules will be provided by Sina Noandish Tabiat Company. Intervention 2: Control group: This group will receive a softgel containing 1.5 ml of additives every 12 hours and for 3 months. The capsules will be provided by Sina Noandish Tabiat. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Mostafa Araj-Khodaei
Aging Research Institute, Faculty of medicine, Tabriz University of Medical Sciences, Golgasht Street
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3334 2178 araj@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Mostafa Araj-Khodaei
Aging Research Institute, Faculty of medicine, Tabriz University of Medical Sciences, Golgasht Street
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3334 2178 araj@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients with MS who had a stable condition for at least 8 weeks before entering the study The score and assessment of fatigue of the people included in the study by the tests should be higher than the minimum standards The psychotropic treatment regimens that the patients had before the start of the study should be adjusted for at least 4 weeks before the start of the study. 18 years 60 years Both The patient has not had a relapse attack in the last 4 months The patient has not had an active infection in the last 4 months The patient has not received a corticosteroid pulse in the last 4 months. History of suicide attempts or suicidal thoughts G35 Multiple sclerosis Treatment - Drugs Placebo Intervention group: This group will receive a capsule containing 0.75 ml Flaxseed and 0.75 ml Nigella Sativa soft gels every 12 hours and for 3 months. The capsules will be provided by Sina Noandish Tabiat Company. Control group: This group will receive a softgel containing 1.5 ml of additives every 12 hours and for 3 months. The capsules will be provided by Sina Noandish Tabiat. Fatigue in MS patients. Timepoint: MFIS questionnaire before taking and three months after taking drugs. Method of measurement: Questionnaire. Tabriz University of Medical Sciences Approved 2022-10-10 Ethics committee of Tabriz University of Medical Sciences Research Vice Chancellor, Third Floor, Central Building No. 2, Tabriz University of Medical Sciences, Golgasht Street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)