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IRCT20221002056071N1 IRCT 2022-12-29 Dezfoul University of Medical Sciences The effect of royal jelly on inflammatory mediators in multiple sclerosis patients Evaluation of the effect of royal jelly consumption on inflammatory mediators including interleukin-1-beta, interleukin-6, interferon-gamma and tumor necrosis factor in patients with multiple sclerosis 2023-01-10 anticipated 60 Complete https://irct.ir/trial/66120 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted block randomization method will be used and randomization unit is individual. According to the sample size of 60 and two treatment groups, 10 blocks with volume 6 are prepared, for this, a list of six combinations of Royal Jelly and placebo is prepared and randomly allocated each compound to one block. In order to reduce the prediction rate, the therapist is not aware of the permutation block method and especially the size of the block, Blinding description: Blinding in this study means that the patient does not know whether he is taking a placebo or a capsule containing royal jelly. The appearance of the capsules is the same, and the researcher who gives the capsules to the two groups is completely unaware of whether they are placebo or contain gel. Even numbers of capsules containing gel are given to patients with odd numbers of placebo. 3 Multiple sclerosis. Intervention 1: Intervention group:The case group (30 MS patients) received sixty 500mg capsules of royal jelly prepared by Rodin Food Industry Company and they were asked to eat one capsule daily before one of their meals. Intervention 2: 30 MS patients as case group received sixty capsules contained 500g Royal jelly) which were prepared from Rodin Food Industry Company and they were asked to eat one capsule daily before one of the meals. . No - There is not a plan to make this available Justification or reason for not sharing IPD is There is a plan to release it
public Mahin Behzadifard
Azadegan
Dezful Iran (Islamic Republic of) 1930429878 +98 66 4242 9533 mahinbehzadi2020@gmail.com Dezfoul University of Medical Sciences scientific Mahin Behzadifard
Azadegan
Dezful Iran (Islamic Republic of) 1930429878 +98 66 4242 9533 mahinbehzadi2020@gmail.com Dezfoul University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria of participants:: Patients' subtype of M.S should be the "relapsing-remitting MS" (RRMS). The patient's age should be 20- 45 years old and all of them treated with interferon for at least 6 months. 20 years 45 years Both Patients with anemia, chronic heart disease, lung disease, diabetic Mellitus, autoimmune diseases such as rheumatoid arthritis, SLE, liver diseases, and a history of asthma and allergies. Patients are treated with corticosteroids or ACTH drugs, or consumption of supplements. G35-G37 Demyelinating diseases of the central nervous system Treatment - Drugs Treatment - Drugs Intervention group:The case group (30 MS patients) received sixty 500mg capsules of royal jelly prepared by Rodin Food Industry Company and they were asked to eat one capsule daily before one of their meals. 30 MS patients as case group received sixty capsules contained 500g Royal jelly) which were prepared from Rodin Food Industry Company and they were asked to eat one capsule daily before one of the meals. . Expanded Disability Status Scale. Timepoint: Study of "Expanded Disability Status Scale" at the beginning of the study and on day 60 after the use of Royal Jelly. Method of measurement: Scoring from zero (best condition) to 10 (death due to MS) according to the neurologist. The amount of change in the amount of inflammatory cytokines. Timepoint: Investigating the level of inflammatory cytokines at the beginning of the study and on the 60th day after the end of using royal jelly. Method of measurement: Eliza method. Dezfoul University of Medical Sciences Approved 2022-11-01 Iran National Committe for Ethics in Biomedical research Azadegan Dezful Khouzestan Iran (Islamic Republic of)