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IRCT20180612040073N2 IRCT 2018-11-30 University of Sistan and Baluchestan The effect of exercise and royal jelly on inflammatory factors in multiple sclerosis patients Effect of 6 weeks aerobic exercise and oral Royal Jelly on TNF-alpha, hs-CRP and neutrophil in multiple sclerosis patients 2018-11-22 anticipated 60 Complete https://irct.ir/trial/33323 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization method: Simple Random unit: Individual Randomization Tool: Sealed Envelope, Blinding description: Participants: The first and second intervention groups will have joint physical activity, but they will be blinded to royal jelly and placebo in the study. The third intervention group and the control group will be blinded to royal jelly and placebo in the study. 3 Multiple sclerosis. Intervention 1: First intervention group: Exercise and Royal jelly Name of the used substance: Royal Jelly Capsule Chemical composition and concentration: Each capsule contains 1000 mg of Natural Royal Jelly in a base of Soya Oil and Soya Lecithin. Dosage: 1 capsule contains 1000 mg Usage frequency: 1 capsule every morning Duration of use: 42 days (6 weeks) Consumption instruction: Oral. Intervention 2: Second intervention group: Exercise and placebo Name of the used substance: Placebo Usage frequency: 1 capsule every morning Duration of use: 42 days (6 weeks) Consumption instruction: Oral. Intervention 3: Third intervention group: Royal jelly Name of the used substance: Royal Jelly Capsule Chemical composition and concentration: Each capsule contains 1000 mg of Natural Royal Jelly in a base of Soya Oil and Soya Lecithin. Dosage: 1 capsule contains 1000 mg Usage frequency: 1 capsule every morning Duration of use: 42 days (6 weeks) Consumption instruction: Oral. Intervention 4: Control group: Placebo Dosage: 1 capsule contains 1000 mg Usage frequency: 1 capsule every morning Duration of use: 42 days (6 weeks) Consumption instruction: Oral. 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 There is no more information.
public Majid Vahidian-Rezazadeh
No. 129, Pardisan 1 Ave, University Residential Complex, Daneshgah Blvd
Zahedan Iran (Islamic Republic of) 9816744687 +98 54 3341 6107 vahidian@ped.usb.ac.ir University of Sistan and Baluchestan scientific Majid Vahidian-Rezazadeh
No. 129, Pardisan 1 Ave, University Residential Complex, Daneshgah Blvd
Zahedan Iran (Islamic Republic of) 9816744687 +98 54 3341 6107 vahidian@ped.usb.ac.ir University of Sistan and Baluchestan Iran (Islamic Republic of) Multiple sclerosis patients: Expanded Disability Status Scale (EDSS) between 0-4 Lack of any supplement Lack of cardiovascular disease no limit no limit Both Multiple sclerosis patients: EDSS more than 4 Use of pharmaceutical supplements With cardiovascular disease G35 Multiple sclerosis Treatment - Other Treatment - Other Treatment - Other Treatment - Other First intervention group: Exercise and Royal jelly Name of the used substance: Royal Jelly Capsule Chemical composition and concentration: Each capsule contains 1000 mg of Natural Royal Jelly in a base of Soya Oil and Soya Lecithin. Dosage: 1 capsule contains 1000 mg Usage frequency: 1 capsule every morning Duration of use: 42 days (6 weeks) Consumption instruction: Oral Second intervention group: Exercise and placebo Name of the used substance: Placebo Usage frequency: 1 capsule every morning Duration of use: 42 days (6 weeks) Consumption instruction: Oral Third intervention group: Royal jelly Name of the used substance: Royal Jelly Capsule Chemical composition and concentration: Each capsule contains 1000 mg of Natural Royal Jelly in a base of Soya Oil and Soya Lecithin. Dosage: 1 capsule contains 1000 mg Usage frequency: 1 capsule every morning Duration of use: 42 days (6 weeks) Consumption instruction: Oral Control group: Placebo Dosage: 1 capsule contains 1000 mg Usage frequency: 1 capsule every morning Duration of use: 42 days (6 weeks) Consumption instruction: Oral Tumor necrosis factor alpha changes. Timepoint: Blood sampling at the beginning of the study (24 hours before the intervention) and 24 hours after the last session of the research protocol. Method of measurement: "Tumor necrosis factor alpha" test kit. High-sensitivity C-reactive Protein Changes. Timepoint: Blood sampling at the beginning of the study (24 hours before the intervention) and 24 hours after the last session of the research protocol. Method of measurement: "High-sensitivity C-reactive Protein" test kit. Neutrophils counts. Timepoint: Blood sampling at the beginning of the study (24 hours before the intervention) and 24 hours after the last session of the research protocol. Method of measurement: Automatic cell counting machine. University of Sistan and Baluchestan Approved 2018-07-15 Ethics committee of Zahedan University of Medical Sciences Ali Ebn Abitaleb Hospital, Salamat Blvd., Persian Gulf Highway Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)