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IRCT20210419051012N1 IRCT 2021-07-08 Hamedan University of Medical Sciences The effect of Oleoylethanolamide supplementation on oxidative stress parameters in multiple sclerosis patients The effect of Oleoylethanolamide (OEA) supplementation on oxidative stress parameters in multiple sclerosis patients : A randomized clinical trial 2021-08-05 anticipated 50 Complete https://irct.ir/trial/55860 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For this purpose, we will use the method of four random blocks (Block Randomization). For this purpose, we prepare four sheets of paper. Write the letter A on two sheets and the letter B on the other two sheets. (Only researcher knows code A, B is an intervention or placebo). The mixed sheets are placed in the pharmacy desk drawer. Upon referral to any of the eligible patients, one of the leaflets is randomly pulled out and based on this leaflet is A or B. The desired drug is removed from box A or B and delivered to the patient. And the type of medicine received is recorded. It should be noted that the extracted sheets will not be returned to the drawer until all four sheets have been removed.After randomly pulling out all four sheets, all the sheets are returned to the drawer and the above procedure will be continued for the next four patients until the desired sample size (50 patients) is reached, Blinding description: This study is a three-blind study in which the patient, physician and analyst have no information about the type of drug used. In this way, after explaining the study to Binar and obtaining written permission from him, the doctor instructed the patient to refer to the pharmacy to receive DA or placebo. Do not mix with the pharmacist delivered with the code a, b and make it available to the pharmacy. The pharmacy provides the patient with the drugs identified by the code a, b randomly blocking the patient.Also, when evaluating the results, the analyst will be informed about the type of drug in the two groups with the code a and b, and after completing the analysis, this coding will be determined by the researcher. 2 Multiple sclerosis. Intervention 1: Intervention group: Take two oleoyl ethanamide supplements (250 mg) daily orally for six weeks. Supplements are provided by Karen Company. Intervention 2: Control group: Take two placebo capsules daily (capsule that is not oleoyl ethanlamide but patients have not been told about it) for 6 weeks. 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 Akram Ranjbar
Shahid Fahmideh Blvd., Hamadan University of Medical Sciences
Hamedan Iran (Islamic Republic of) 6516848741 +98 81 3827 4191 a.ranjbar@umsha.ac.ir Hamedan University of Medical Sciences scientific Akram Ranjbar
Shahid Fahmideh Blvd., Hamadan University of Medical Sciences
Hamedan Iran (Islamic Republic of) 6517838678 +98 81 3827 4191 a.ranjbar@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) MS type of relapsing_remitting MS patients are treating with beta interferon Willingness to cooperate Patients with an age range of 20 to 40 years 20 years 40 years Both MS patients are treating with Corticosteroids Taking immunosuppressive drugs History of rheumatic and collagen and vascular diseases History of recent infections (during the last 2 to 3 months) Swallowing disorders that are unable to take medication Sensitivity to compounds No regular use of supplements Reluctance to cooperate G35 Multiple sclerosis Treatment - Drugs Treatment - Drugs Intervention group: Take two oleoyl ethanamide supplements (250 mg) daily orally for six weeks. Supplements are provided by Karen Company. Control group: Take two placebo capsules daily (capsule that is not oleoyl ethanlamide but patients have not been told about it) for 6 weeks. Red blood cell. Timepoint: Before and after the intervention. Method of measurement: laboratory. White blood cell. Timepoint: Before and after the intervention. Method of measurement: laboratory. Plt. Timepoint: Before and after the intervention. Method of measurement: laboratory. Interleukin 17. Timepoint: Before and after the intervention. Method of measurement: ELISA. TNF-α. Timepoint: Before and after the intervention. Method of measurement: ELISA. UREA. Timepoint: Before and after the intervention. Method of measurement: Labratory. TG. Timepoint: Before and after the intervention. Method of measurement: Laboratory. Cholesterol. Timepoint: Before and after the intervention. Method of measurement: Laboratory. PLT. Timepoint: Before and after the intervention. Method of measurement: Laboratory. Total antioxidant capacity. Timepoint: Before and after the intervention. Method of measurement: Spectrophotometer. Catalase enzyme activity. Timepoint: Before and after the intervention. Method of measurement: Spectrophotometer. Protein oxidation. Timepoint: Before and after the intervention. Method of measurement: Spectrophotometer. Hamedan University of Medical Sciences Approved 2021-01-19 Research Ethics Committee of Hamadan University of Medical Sciences Shahid Fahmideh Blvd., Hamadan University of Medical Sciences Hamedan Hamadan Iran (Islamic Republic of)