Effect of oral nanocurcumin on disease activity, expression levels of microRNA and Th17 cells and Treg cells development factors and serum IL-17, IL-10 level in Behcet patients

Effect of oral nanocurcumin on disease activity, expression levels of microRNA and Th17 cells and Treg cells development factors and serum IL-17 level in Behcet patients

ِDouble-blinded clinical trial with control group, with parallel groups, randomized. Patients were randomly assigned into two groups of control (n=18) receiving placebo capsules and treated group (n=18) receiving nanocurcumin capsules

In this study, the patients with Behcet's syndrome is studied. These individuals are selected randomly from among referrals to rheumatologist at Tabriz University of Medical Sciences, based on laboratory findings and medical records content. The treatment group will receive 80 mg of nanocurcumin The control group will also receive placebo capsules.

Inclusion criteria: Age 20-60 years Diagnosis of Behcet's disease by rheumatologist Selection of patients based on IBCD (International Criteria for Behcet's Disease), suggests that vascular, eye and joints threatening conflicts indicate severity of disease Exclusion criteria: Using nutritional supplements and antioxidant and alpha-lipoic acid during a month before study; Pregnancy&lactation; History of diabetes and other chronic diseases; history of other autoimmune diseases; Admission rate<70% of supplemental intake; Smoking

The treatment group will receive 80 mg of nanocurcumin The control group will also receive placebo capsules.

In this study, the effect of oral nanocurcumin were investigated on the expression of miRNA326, miRNA 155, miRNA181, the frequency of Treg calls and Th17 cells, the expression of the RoRγt، Foxp3, the expression of the IL-23 and IL-17, IL-10 ، TGF-b , and the secretion levels of these cytokines in patients with Behcet disease compared with the control group.

- Use of corticosteroids during illness is removed from exclusion criteria.

From among the patients who volunteer to participate in the study, 36 individuals will be selected by simple randomization. Randomization method: Blocking Randomization unit: individual stratification: age and sex Randomization tool: Random allocation software Method of random sequence generation: Random allocation software Allocation concealment: The generated random sequence will be kept in a protected location and administered by an independent party who is not involved in the trial throughout the study. Due to proper allocation concealment, trial investigators and participants will be unaware of upcoming allocations.

This is a double blind study in which the researcher and patients who participate in study will be blinded to the group assignments. The patients will receive the supplements by another person who is not involved in doing the assessment and chemical analysis. Patients will be informed about the type of supplements (nanocurcumin and placebo) however they will not be aware about the group assignments. Placebo capsules are identical to nanocurcumin supplements in shape and color and size.