The effect of Oleoylethanolamide (OEA) supplementation on oxidative stress parameters in multiple sclerosis patients : A randomized clinical trial

Evaluation of the effect of oleoyl ethanamide supplementation on inflammatory parameters and biomarkers of oxidative stress in MS patients

A total of 50 patients were randomly divided into two groups receiving oleoyl ethanamide supplement and placebo by simple random sampling method. Clinical trial with control group, with parallel groups, three-way blind, randomized

Fifty patients referred to Shahid Beheshti Hospital in Hamadan (consecutively) who have MS at the diagnosis of a physician, were randomly divided into two groups with respect to allocation (Allocation Concealment). Blinding all organs so that patients are known only by computer code. The treatment codes will be revealed at the end of the study, and it is unclear whether a placebo or supplement will be given, as the placebo capsules will look exactly like oleoyl ethanlamide. Written consent is obtained from patients to participate in the study and participate in sampling. After the intervention, blood is taken from these patients and examined.

Inclusion criteria: Willingness to cooperate Recurrent-restricted MS patient Exclusion conditions: Immunosuppressive drugs History of rheumatic and collagen and vascular diseases History of recent infections (during the last 2 to 3 months) Swallowing disorders who are unable to take drugs Sensitivity To non-regular use compounds complement the unwillingness to cooperate

The intervention group should receive 2 oleoyl ethanamide supplements (250 mg) daily with main meals for 6 weeks. The control group should also take 2 placebo capsules daily for 6 weeks.

Inflammatory parameters and biomarkers of oxidative stress

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.

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.