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IRCT20180612040073N1 IRCT 2018-11-10 University of Sistan and Baluchestan The effect of exercise and royal jelly on total antioxidant capacity and glutathione peroxidase in multiple sclerosis patients Effect of 6 weeks aerobic ergometer and royal jelly on total antioxidant capacity and glutathione peroxidase in multiple sclerosis patients 2018-11-21 anticipated 60 Complete https://irct.ir/trial/33324 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 not be aware of the royal jelly and placebo in the study. The third intervention group and the control group will not be aware of the 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 its 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. No - There is not a plan to make this available Justification or reason for not 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 No use of any supplement Lack of cardiovascular disease no limit no limit Both Non-MS Patients 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 its 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 Total antioxidant capacity 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: "Total antioxidant capacity" test kit. Glutathione peroxidase 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: "Glutathione peroxidase" test kit. 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)