Multiple Sclerosis Clinical Trial
Official title:
The Effects of Oral Nanocurcumin on Expression Levels of microRNAs and Treg Cells and Th17 Cells Development Factors in Multiple Sclerosis Patients
Verified date | May 2017 |
Source | Tabriz University of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 41 |
Est. completion date | November 7, 2017 |
Est. primary completion date | August 10, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Willingness to cooperate - Aged 18 to 65 years - The diagnosis of Multiple sclerosis by Neurologist - Patients in Relapsing Remitting (RRMS) - Patients with Expanded Disability Status Scale (EDSS) <5/5. Exclusion Criteria: - Use of nutritional supplements and antioxidant and immunosuppressive drugs alpha-lipoic acid a month before the study. - Pregnancy and lactation - History of diabetes and other chronic diseases - History of other autoimmune diseases - Occurrence of relapses during the study period - Acceptance rate of less than 70% of supplements - Unwillingness to continue to cooperate |
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Drug Applied Research Center, Tabriz, Iran | Tabriz |
Lead Sponsor | Collaborator |
---|---|
Tabriz University of Medical Sciences |
Iran, Islamic Republic of,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | EDSS measurment | EDSS measurment by neurologist | 6 months after treatment | |
Secondary | Treg cells frequency | Flowcytometry (Treg cells produce anti-inflammatory cytokines) | 6 months after treatment | |
Secondary | Th17 cells frequency | Flowcytometry (Th17 cells produce inflammatory cytokine and increase inflammation) | 6 months after treatment | |
Secondary | IL-17 and ROR?t expression | qPCR method | 6 months after treatment | |
Secondary | IL-17 secretion levels | ELISA method | 6 months after treatment | |
Secondary | microRNAs (miRNA-326) expression | Evaluate the diagnostic value of microRNAs in quantitative polymerase chain reaction (qPCR), in MS patients as compared with healthy control | 6 months after treatment | |
Secondary | TGF-ß and FoxP3 expression | qPCR method | 6 months after treatment | |
Secondary | TGF-ß secretion levels | ELISA method | 6 months after treatment | |
Secondary | microRNAs (miRNA-106b and miRNA-25) expression | Evaluate the diagnostic value of microRNAs in quantitative polymerase chain reaction | 6 months after treatment |
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