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IRCT20120215009014N375 IRCT 2021-01-22 Hamedan University of Medical Sciences Effect of probiotic and zinc supplementation separately and in combination on reducing the complication of influenza-like syndrome during therapy by beta-interferon in patients with relapsing-remitting multiple sclerosis Effect of probiotic and zinc supplementation separately and in combination on reducing the complication of influenza-like syndrome during therapy by beta-interferon in patients with relapsing-remitting multiple sclerosis: a randomized clinical trial 2021-04-04 anticipated 60 Complete https://irct.ir/trial/53804 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be randomly assigned to intervention groups using block randomization. For this purpose, we will prepare six sheets of paper, writing on two sheets the name of the intervention 1 and on two other sheets the name of the intervention 2 and on the third two sheets the name of the intervention 3. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all six sheets are drawn. The six paper sheets will be then placed back into the container, and this action repeated until the sample size is reached. 2 Relapsing-remitting multiple sclerosis. Intervention 1: Intervention group 1: Beta-interferon-1a 30 micrograms once a week intramuscular and Beta-interferon-1b 250 micrograms every-other-day subcutaneously for 3 months plus tablet zinc oxide 10 mg daily for 3 months and capsule probiotic lactocare 500 mg daily for 3 months. Intervention 2: Intervention group 2: Beta-interferon-1a 30 micrograms once a week intramuscular and Beta-interferon-1b 250 micrograms every-other-day subcutaneously for 3 months plus tablet zinc oxide 10 mg daily for 3 months. Intervention 3: Intervention group 3: Beta-interferon-1a 30 micrograms once a week intramuscular and Beta-interferon-1b 250 micrograms every-other-day subcutaneously for 3 months plus capsule probiotic lactocare 500 mg daily for 3 months. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It depends on the situations and the results of the study as well as the approval of the financial supporting organization.
public Mehran Fathi
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 mehranfathi1717@gmail.com Hamedan University of Medical Sciences scientific Dr. Fatemeh Nouri
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 fatemenouri1@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Age: 20 to 40 years old Relapsing-remitting multiple sclerosis Corticosteroid therapy for at least 3 weeks 20 years 40 years Both Pregnancy or breastfeeding, Receiving influenza vaccine Respiratory infection in the past 2 weeks, Using alcohol or opioid drugs in the past 2 months, Autoimmune diseases or immunodeficiency syndrome, Abdominal surgery, Short bowel syndrome, Mesenteric Ischemia, History of tuberculosis or AIDS, Liver or renal disease or diabetes or hypertension G35 Multiple sclerosis Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: Beta-interferon-1a 30 micrograms once a week intramuscular and Beta-interferon-1b 250 micrograms every-other-day subcutaneously for 3 months plus tablet zinc oxide 10 mg daily for 3 months and capsule probiotic lactocare 500 mg daily for 3 months Intervention group 2: Beta-interferon-1a 30 micrograms once a week intramuscular and Beta-interferon-1b 250 micrograms every-other-day subcutaneously for 3 months plus tablet zinc oxide 10 mg daily for 3 months Intervention group 3: Beta-interferon-1a 30 micrograms once a week intramuscular and Beta-interferon-1b 250 micrograms every-other-day subcutaneously for 3 months plus capsule probiotic lactocare 500 mg daily for 3 months Influenza-like syndrome. Timepoint: 3 months after intervention. Method of measurement: By history taking. Gastrointestinal complications (nausea, vomiting, abdominal pain), headache and muscle aches, hot flashes, fever and fatigue. Timepoint: 3 months after intervention. Method of measurement: By history taking. Hamedan University of Medical Sciences Approved 2020-11-29 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)