The Immunomodulatory Effects of Oral Nanocurcumin in Multiple Sclerosis Patients

NCT03150966 | Completed Phase 2 DMC

• 1 other identifier: TabrizUMS-Nerve-002
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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. .

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; Nanocurcumin; MicroRNAs; Th17 cells; Treg cells

Outcome Measures

Primary Outcomes (1)

• EDSS measurment

  EDSS measurment by neurologist

  6 months after treatment

Secondary Outcomes (8)

• Treg cells frequency

  6 months after treatment

• Th17 cells frequency

  6 months after treatment

• IL-17 and RORγt expression

  6 months after treatment

• IL-17 secretion levels

  6 months after treatment

• microRNAs (miRNA-326) expression

  6 months after treatment

Study Arms (2)

Patients who received nanocurcumin

EXPERIMENTAL

Patients who received nanocurcumin

Drug: Nanocurcumin

Patients who received placebo

PLACEBO COMPARATOR

Patients who received placebo

Drug: Placebo

Interventions

Nanocurcumin DRUG

Patients will take 80 mg nanocurcumin in the form of capsules daily during the 6 month study period

Also known as: Patients who received nanocurcumin

Patients who received nanocurcumin

Placebo DRUG

Patients will take placebo in the form of capsules daily during 6 months study period

Also known as: Patients who received placebo

Patients who received placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tabriz University of Medical Sciences: lead

Study Sites (1)

Drug Applied Research Center, Tabriz, Iran

Tabriz, Iran

Location

Related Publications (8)

• Hoang PD, Cameron MH, Gandevia SC, Lord SR. Neuropsychological, balance, and mobility risk factors for falls in people with multiple sclerosis: a prospective cohort study. Arch Phys Med Rehabil. 2014 Mar;95(3):480-6. doi: 10.1016/j.apmr.2013.09.017. Epub 2013 Oct 3.

  PMID: 24096187 BACKGROUND

• Schneider A, Long SA, Cerosaletti K, Ni CT, Samuels P, Kita M, Buckner JH. In active relapsing-remitting multiple sclerosis, effector T cell resistance to adaptive T(regs) involves IL-6-mediated signaling. Sci Transl Med. 2013 Jan 30;5(170):170ra15. doi: 10.1126/scitranslmed.3004970.

  PMID: 23363979 BACKGROUND

• Schwarz A, Schumacher M, Pfaff D, Schumacher K, Jarius S, Balint B, Wiendl H, Haas J, Wildemann B. Fine-tuning of regulatory T cell function: the role of calcium signals and naive regulatory T cells for regulatory T cell deficiency in multiple sclerosis. J Immunol. 2013 May 15;190(10):4965-70. doi: 10.4049/jimmunol.1203224. Epub 2013 Apr 10.

  PMID: 23576680 BACKGROUND

• Jadidi-Niaragh F, Mirshafiey A. Th17 cell, the new player of neuroinflammatory process in multiple sclerosis. Scand J Immunol. 2011 Jul;74(1):1-13. doi: 10.1111/j.1365-3083.2011.02536.x.

  PMID: 21338381 BACKGROUND

• Rao TS, Basu N, Siddiqui HH. Anti-inflammatory activity of curcumin analogues. Indian J Med Res. 1982 Apr;75:574-8. No abstract available.

  PMID: 7118227 BACKGROUND

• Lescher J, Paap F, Schultz V, Redenbach L, Scheidt U, Rosewich H, Nessler S, Fuchs E, Gartner J, Bruck W, Junker A. MicroRNA regulation in experimental autoimmune encephalomyelitis in mice and marmosets resembles regulation in human multiple sclerosis lesions. J Neuroimmunol. 2012 May 15;246(1-2):27-33. doi: 10.1016/j.jneuroim.2012.02.012. Epub 2012 Mar 22.

  PMID: 22445295 BACKGROUND

• Martinelli-Boneschi F, Fenoglio C, Brambilla P, Sorosina M, Giacalone G, Esposito F, Serpente M, Cantoni C, Ridolfi E, Rodegher M, Moiola L, Colombo B, De Riz M, Martinelli V, Scarpini E, Comi G, Galimberti D. MicroRNA and mRNA expression profile screening in multiple sclerosis patients to unravel novel pathogenic steps and identify potential biomarkers. Neurosci Lett. 2012 Feb 2;508(1):4-8. doi: 10.1016/j.neulet.2011.11.006. Epub 2011 Nov 7.

  PMID: 22108567 BACKGROUND

• Du C, Liu C, Kang J, Zhao G, Ye Z, Huang S, Li Z, Wu Z, Pei G. MicroRNA miR-326 regulates TH-17 differentiation and is associated with the pathogenesis of multiple sclerosis. Nat Immunol. 2009 Dec;10(12):1252-9. doi: 10.1038/ni.1798. Epub 2009 Oct 18.

  PMID: 19838199 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

nanocurcumin

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Mehdi Yousefi, Ph.D

  Tabriz University of Medical Scienses

  STUDY DIRECTOR

• Hormoz Ayromlou, Neurologist

  Tabriz University of Medical Scienses

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2017
• First Posted: May 12, 2017
• Study Start: June 8, 2016
• Primary Completion: August 10, 2017
• Study Completion: November 7, 2017
• Last Updated: September 17, 2018

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)