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IRCT20220116053732N1 IRCT 2022-05-08 Dezfoul University of Medical Sciences Evaluation of protective effect of Royal Jelly on Serum Oxidative Stress markers and Interleukin-1 Beta of Patients with Multiple Sclerosis. Evaluation of protective effect of Royal Jelly on Serum Oxidative Stress markers and Interleukin-1Beta of Patients with Multiple Sclerosis. 2022-03-06 anticipated 60 Complete https://irct.ir/trial/61321 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, 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: Patients were invited to participate in the study and after obtaining informed consent, they were blindly classified into control or intervention groups. The clinician, researcher, outcome evaluator, and data analyst all play their role blindly. 3 MS disease. Intervention 1: The intervention group included people with MS who on the first day of the study and on the 50th day of the study "after swallowing a capsule containing 350 mg of royal jelly lyophilized daily", "Extensive disability status scale" and blood sampling to assess the status of "oxidative stress "It will be measured. The study of oxidative stress is done by measuring factors such as malondialdehyde, catalase, superoxide dismutase and nitric oxide. Intervention 2: Control group included people with MS who on the first day of the study and on the 50th day of the study "after swallowing a capsule containing 350 mg of wheat flour daily", "Extensive disability status scale" and blood sampling to assess the status of "oxidative stress "It will be measured. The study of oxidative stress is done by measuring factors such as malondialdehyde, catalase, superoxide dismutase and nitric oxide. Yes - There is a plan to make this available What will be shared: No When: No To whom: No Conditions: No Where to obtain: No How to obtain: No Comments:
public Dr. Susan Sabbagh
No. 37, Fajr St., Shahid Beheshti St., Dezful
Dezful Iran (Islamic Republic of) 6461116174 +98 61 4222 2709 sabbaghsusan@yahoo.com Dezfoul University of Medical Sciences scientific Dr. Susan Sabbagh
No. 37, Fajr St., Shahid Beheshti St., Dezful
Dezful Iran (Islamic Republic of) 6461116174 +98 61 4222 2709 sabbaghsusan@yahoo.com Dezfoul University of Medical Sciences Iran (Islamic Republic of) Age of patients should be 20-45 The sub type of M.S should be "Relapsing-Remitting MS" (RRMS). The diagnosis of "RRMS" is confirmed by a neurologist based on neurological examination and imaging. Patients should be 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, ... Patients treated with corticosteroids or ACTH. Use of any supplements by patients. History of asthma and allergies in the patient. Occurrence of allergic symptoms during the study Occurrence of a "MS" attack during the study period. The patient' s refuse to continue study. G35 Multiple sclerosis (of):NOS brain stem cord disseminated generalized Treatment - Drugs Placebo The intervention group included people with MS who on the first day of the study and on the 50th day of the study "after swallowing a capsule containing 350 mg of royal jelly lyophilized daily", "Extensive disability status scale" and blood sampling to assess the status of "oxidative stress "It will be measured. The study of oxidative stress is done by measuring factors such as malondialdehyde, catalase, superoxide dismutase and nitric oxide. Control group included people with MS who on the first day of the study and on the 50th day of the study "after swallowing a capsule containing 350 mg of wheat flour daily", "Extensive disability status scale" and blood sampling to assess the status of "oxidative stress "It will be measured. The study of oxidative stress is done by measuring factors such as malondialdehyde, catalase, superoxide dismutase and nitric oxide. The rate of change of oxidative stress state. Timepoint: Evaluation of "oxidative stress status" at the beginning of the study and on day 30 after the use of Royal Jelly. Method of measurement: The assay of Malondialdehyde , Superoxide dismutase, Catalase, Nitric oxide. Expanded Disability Status Scale. Timepoint: Study of "Expanded Disability Status Scale" at the beginning of the study and on day 30 after the use of Royal Jelly. Method of measurement: Scoring from zero (best condition) to 10 (death due to MS) according to the neurologist. Dezfoul University of Medical Sciences Approved 2020-09-28 Ethics committee of Dezful University of Medical Sciences Azadegan boulevard, deputy of training, school of medicine, Dezful, lran. Dezful Khouzestan Iran (Islamic Republic of)