Evaluation of the effect of royal jelly consumption on inflammatory mediators including interleukin-1-beta, interleukin-6, interferon-gamma and tumor necrosis factor in patients with multiple sclerosis

Evaluating the effect of royal jelly consumption on the level of inflammatory mediators including interleukin-1-beta, interleukin-6, interferon gamma and tumor necrosis factor in patients with multiple sclerosis.

Division of 60 patients (random and double-blind) into two intervention and control groups, phase 3 trial, 60 half-gram capsules of royal jelly or placebo per patient (60 days), blood sampling at the beginning and after the 60th day, measurement of interleukin 1 beta, tumor necrosis factor alpha, interleukin 6 and interferon gamma and EDSS after intervention.

This study is conducted in Dezful University of Medical Sciences. 60 MS patients in two groups, case and control, before and after blood sampling and their inflammatory cytokine levels are measured.

MS Patients who have been diagnosed with the disease based on neurological examinations and imaging by a neurologist, and their disease subtype is relapsing, improving or secondary progressive, and have been treated with interferon drugs and have at least six A month has passed since the start of their drug treatment, they are included in the study Criteria for non-entry 1. Patients suffering from anemia, chronic heart diseases, lung diseases, diabetes, autoimmune diseases such as rheumatoid arthritis, SLE, suffering from liver diseases, patients who are being treated with immunosuppressive drugs. History of asthma and allergy in the patient.

60 patients were randomly divided into two intervention and control groups in a double-blind manner, and 60 half-gram capsules of royal jelly or placebo were delivered to each patient to consume one capsule daily before a meal.

IL-6,TNF-α ,IFN-γ IL-1β and EDSS score

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 in this study means that the patient does not know whether he is taking a placebo or a capsule containing royal jelly. The appearance of the capsules is the same, and the researcher who gives the capsules to the two groups is completely unaware of whether they are placebo or contain gel. Even numbers of capsules containing gel are given to patients with odd numbers of placebo.

There is a plan to release it