The Immunomodulatory Effects of Oral Nanocurcumin in Multiple Sclerosis Patients
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Multiple sclerosis is the most common autoimmune disease of the central nervous system, most
      ranging in age from 40-20 years of age is associated with neurons inflammation and
      demyelination. Increasing aggressive activities of Th17 and Th1 cells that their function is
      to secrete proinflammatory cytokines and decreasing the number and activity of regulatory T
      cells, which normally leads to controlling inflammation, are seen in these patients.Many
      studies have carried out to assess the prevalence of Tregs and Th17 in autoimmune disorders
      such as MS. The Treg /Th17 functional balance is necessary for the impediment of autoimmune
      and inflammatory diseases by preventing harmful injury to the host and increasing effective
      immune responses. miRNAs have been shown to play a pivotal role in the pathogenesis of
      various diseases including autoimmune or auto-inflammatory diseases. Curcumin, the active
      principle constituent of turmeric, is proved to be capable of regulating cellular responses
      and the growth of different cell types in the immune system such as B cells, T cells,
      macrophages, dendritic cells and natural killer cells. Curcumin has a combination of
      activities such as anti-inflammatory, antioxidant, anti-proliferation, anti-invasive, and can
      used in the treatment of Alzheimer's, Parkinson's, Multiple sclerosis, Cardiovascular
      disease, Bacterial diseases and Arthritis. The solubility of curcumin in nanomicelles
      spherical water increases to more than 100 thousand times, which significantly enhances the
      absorption of curcumin. The present study aimed at investigating the effects of nanocurcumin
      on the frequency of Treg and Th17 cells, expression levels of their associated transcription
      factors and cytokines, secretion levels of their associated cytokines and also related miRNAs
      expression levels in peripheral blood of patients with MS.

      .
    

Detailed description: 
      In this study, fresh blood samples were acquired from 50 MS patients introduced by
      corresponding physician and Neurologist. As the aim of the current study was the assessment
      of nanocurcumin in MS patients, the peripheral blood collection was collected in two steps.
      After the first blood collection via venipuncture, 25 patients received nanocurcumin capsules
      each day and the remaining 25 patients took placebo for 6 months. Accordingly, the second
      sampling from the mentioned population was collected after 6 months. 9 patients were excluded
      from the study: 3 did not provide informed consent, 5 lived quite far away from the place in
      which follow-up examinations were performed, and 1 patient developed cancer. In all cases, 15
      ml of blood was utilized for peripheral blood mononuclear cells (PBMC) isolation. PBMC is
      used to measure the expression levels of miRNA-106b, miRNA-25 and miRNA-326. In this regard,
      specific kits extracted miRNA from cells is used. Then the version of miRNA using
      Quantitative Real time polymerase chain reaction(qPCR).Then the frequency of Treg and Th17
      cells in peripheral blood of patients will be examined by Flowcytometry and compared to the
      control group. The expression of key transcription factor (Foxp3) and specific cytokines
      (TGF-β) related to the Treg cells and key transcription factor (RORγt) and specific
      cytokines, interleukin-17(IL-17), related to the Th17 are measured by Quantitative Real time
      PCR. Elisa methos is used to assess the amount of the cytokine TGF-β and IL-17 in cultured
      cells.
    

Intervention name(s): Nanocurcumin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients will take 80 mg nanocurcumin in the form of capsules daily during the 6 month study period; Patients will take placebo in the form of capsules daily during 6 months study period
Other intervention name(s): Patients who received nanocurcumin; Patients who received placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Multiple sclerosis; Nanocurcumin; MicroRNAs; Th17 cells; Treg cells