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Trial record 3 of 372 for:    Ankylosing Spondylitis

The Effects of Nanocurcumin on Serum miRNA and Th17 Cells Development Factors in Ankylosing Spondylitis Patients

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ClinicalTrials.gov Identifier: NCT03140657
Recruitment Status : Recruiting
First Posted : May 4, 2017
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Tabriz University of Medical Sciences

Brief Summary:
Ankylosing spondylitis is a chronic autoimmune disease in which T cells associated with the disorder. The disease often affects the spine and hip bones. Inflammation involved in the area of the sacrum - Sacroiliac hip joints, pelvis, spinal lumbar, thoracic and cervical. Curcumin is a polyphenol. It is an active component of turmeric which is a perennial plant. Curcumin binding with a range of protein and the have ability to inhibit the activity of various kinases. Curcumin has a combination of activities such as antioxidant, anti-proliferation, anti-invasive, and can used in the treatment of Alzheimer's, Parkinson's, Multiple sclerosis, Cardiovascular disease, Bacterial diseases and Arthritis and ankylosing spondylitis. This increases the solubility of curcumin in nanomicelles spherical water to more than 100 thousand times, which significantly enhances the absorption of curcumin. A group of circulating miRNA in plasma is found to be the change they can be involved in inflammation or inhibit it. MiRNA expression profiles in blood and serum samples taken from patients with ankylosing spondylitis review that is miRNA-326 also affects cells of the immune system may be involved in disease ankylosing spondylitis. MiRNA-326 induces differentiation of Th17 cells via specific transcription factors, such as the RoRγt. MiRNA326 increased the expression of transcription factor RoRγt and Th17 cell differentiation TCD4 + cells resulting in the production of inflammatory cytokine IL17 increased inflammation and progression of inflammatory disease ankylosing spondylitis (AS).

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: Nanocurcumin Drug: Placebo Phase 2

Detailed Description:
This study is a randomized double-blind placebo control clinical trial conducted on two groups for 4 months. Patients receive oral nanocurcumin (80 mg / day) as compared with placebo group. After sampling both groups and separating plasma, peripheral blood mononuclear cells isolated by using ficoll and fresh and cultured in the presence of PHA. PBMC is used to measure the levels of miRNA-326, IL-17 and RORγt expression. the frequency of Th17 cells in peripheral blood will be examined by flowcytometry. To check the amount of the cytokine IL-17 in cultured cells supernatant is used ELISA technique.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Oral Nanocurcumin on Expression Levels of microRNA and Th17 Cells Development Factors in Ankylosing Spondylitis Patients
Actual Study Start Date : April 29, 2017
Estimated Primary Completion Date : May 28, 2018
Estimated Study Completion Date : June 7, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nanocurcumin Arm
Nanocurcumin capsules (the formulation of curcumin nanoparticles, Exirnanosina). Subjects randomized to Nanocurcumin Arm will receive 80 mg/day for 4 month.
Drug: Nanocurcumin
Nanocurcumin capsules (the formulation of curcumin nanoparticles, Exirnanosina). Subjects randomized to Nanocurcumin Arm will receive 80 mg/day for 4 month

Placebo Comparator: Placebo
Subjects randomized to Placebo Arm will receive placebo in the form of capsules for 4 month
Drug: Placebo
Subjects randomized to Placebo Arm will receive placebo in the form of capsules for 4 month




Primary Outcome Measures :
  1. Assessments of Ankylosing Spondylitis (ASAS) 20 Response [ Time Frame: at 4 months ]
    Number of Subjects With a Reduction in Signs and Symptoms


Secondary Outcome Measures :
  1. Serum mir-326 expression [ Time Frame: at 4 months ]
    qPCR method (miRNA-326 induces differentiation of Th17 cells and increase inflammation)

  2. Serum IL-17 levels [ Time Frame: at 4 months ]
    Elisa method (Th17 cells produce inflammatory cytokine, IL17, and increase inflammation).

  3. Serum RORγt expression [ Time Frame: at 4 months ]
    qPCR method (RoRγt, a transcription factor, induce Th17 cell differentiation and increase inflammation).

  4. IL-17 expression [ Time Frame: at 4 months ]
    qPCR method (Th17 cells produce inflammatory cytokine, IL17, and increase inflammation).

  5. Th17 cells frequency [ Time Frame: at 4 months ]
    Flowcytometry (Th17 cells produce inflammatory cytokine, IL17, and increase inflammation).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willingness to cooperate
  • Aged 28 to 51 years
  • The diagnosis of ankylosing spondylitis by rheumatologist
  • Patients with a BASDAI > 4 as having active disease.
  • Disease duration 5-8 years

Exclusion Criteria:

  • Nutritional supplements and antioxidant 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03140657


Contacts
Contact: Mehdi Yousefi, Ph.D 0912 670 3953 Yousefime@tbzmed.ac.ir

Locations
Iran, Islamic Republic of
Connective Tissue Diseases Research Center Recruiting
Tabriz, Iran, Islamic Republic of, 0413
Contact: Sanam Dolati, Ph.D    0914 402 5684      
Sponsors and Collaborators
Tabriz University of Medical Sciences
Investigators
Study Director: Mehdi Yousefi, Ph.D SCARM institute
Study Director: Mehrzad Hajaliloo Bonab, Rheumatologist Tabriz University of Medical Sciences, Tabriz, Iran

Publications:

Responsible Party: Tabriz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03140657     History of Changes
Other Study ID Numbers: TabrizUMS-Rheumatology-003
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tabriz University of Medical Sciences:
Ankylosing spondylitis, Nanocurcumin, MicroRNA, Th17 cells

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis