Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-01-26 @ 1:21 PM
Study NCT ID:
NCT03140657
Status:
COMPLETED
Last Update Posted:
2019-05-17
First Post:
2017-04-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Nanocurcumin on Treg Cells and Th17 Cells Responses in Ankylosing Spondylitis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}], 'ancestors': [{'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000730654', 'term': 'nanocurcumin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-15', 'studyFirstSubmitDate': '2017-04-28', 'studyFirstSubmitQcDate': '2017-05-02', 'lastUpdatePostDateStruct': {'date': '2019-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessments of Ankylosing Spondylitis Signs and Symptoms (BASDI)', 'timeFrame': '4 months after treatment', 'description': 'Number of Subjects With a Reduction in Signs and Symptoms'}], 'secondaryOutcomes': [{'measure': 'mir-141, mir-155 and mir-200 expression', 'timeFrame': '4 months after treatment', 'description': 'qPCR method (mir-141, mir-155 and mir-200 induces differentiation of Th17 cells and increase inflammation)'}, {'measure': 'Serum IL-17 levels', 'timeFrame': '4 months after treatment', 'description': 'Elisa method (Th17 cells produce inflammatory cytokine, IL17, and increase inflammation).'}, {'measure': 'RORγt expression', 'timeFrame': '4 months after treatment', 'description': 'qPCR method (RoRγt, a transcription factor, induce Th17 cell differentiation and increase inflammation).'}, {'measure': 'IL-17 expression', 'timeFrame': '4 months after treatment', 'description': 'qPCR method (Th17 cells produce inflammatory cytokine, IL17, and increase inflammation).'}, {'measure': 'Th17 cells frequency', 'timeFrame': '4 months after treatment', 'description': 'Flowcytometry (Th17 cells produce inflammatory cytokine, IL17, and increase inflammation).'}, {'measure': 'mir-27, mir-17 and mir-146a expression', 'timeFrame': '4 months after treatment', 'description': 'PCR method (mir-27, mir-17 and mir-146a induces differentiation of Treg cells)'}, {'measure': 'Serum TGF-β, IL-10, IL-6 levels', 'timeFrame': '4 months after treatment', 'description': 'Elisa method (Treg cells produce anti-inflammatory cytokine, and decrease inflammation).'}, {'measure': 'FoxP3 expression', 'timeFrame': '4 months after treatment', 'description': 'qPCR method (FoxP3, a transcription factor, induce Treg cell differentiation and decrease inflammation).'}, {'measure': 'TGF-β, IL-10, IL-6 expression', 'timeFrame': '4 months after treatment', 'description': 'qPCR method (Treg cells produce anti-inflammatory cytokine, and decrease inflammation).'}, {'measure': 'Treg cells frequency', 'timeFrame': '4 months after treatment', 'description': 'Flowcytometry (Treg cells produce anti-inflammatory cytokine, and decrease inflammation).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ankylosing spondylitis, Nanocurcumin, MicroRNA, Th17 cells'], 'conditions': ['Ankylosing Spondylitis']}, 'referencesModule': {'references': [{'pmid': '25452811', 'type': 'BACKGROUND', 'citation': 'Wang C, Liao Q, Hu Y, Zhong D. T lymphocyte subset imbalances in patients contribute to ankylosing spondylitis. Exp Ther Med. 2015 Jan;9(1):250-256. doi: 10.3892/etm.2014.2046. Epub 2014 Nov 4.'}, {'pmid': '26080615', 'type': 'BACKGROUND', 'citation': 'Jethwa H, Bowness P. The interleukin (IL)-23/IL-17 axis in ankylosing spondylitis: new advances and potentials for treatment. Clin Exp Immunol. 2016 Jan;183(1):30-6. doi: 10.1111/cei.12670. Epub 2015 Sep 30.'}, {'pmid': '19247658', 'type': 'BACKGROUND', 'citation': 'Wang X, Lin Z, Wei Q, Jiang Y, Gu J. Expression of IL-23 and IL-17 and effect of IL-23 on IL-17 production in ankylosing spondylitis. Rheumatol Int. 2009 Sep;29(11):1343-7. doi: 10.1007/s00296-009-0883-x. Epub 2009 Feb 27.'}, {'pmid': '7118227', 'type': 'BACKGROUND', 'citation': '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': '23143785', 'type': 'BACKGROUND', 'citation': 'Gupta SC, Patchva S, Aggarwal BB. Therapeutic roles of curcumin: lessons learned from clinical trials. AAPS J. 2013 Jan;15(1):195-218. doi: 10.1208/s12248-012-9432-8. Epub 2012 Nov 10.'}, {'pmid': '26273623', 'type': 'BACKGROUND', 'citation': 'Lv Q, Li Q, Zhang P, Jiang Y, Wang X, Wei Q, Cao S, Liao Z, Lin Z, Pan Y, Huang J, Li T, Jin O, Wu Y, Gu J. Disorders of MicroRNAs in Peripheral Blood Mononuclear Cells: As Novel Biomarkers of Ankylosing Spondylitis and Provocative Therapeutic Targets. Biomed Res Int. 2015;2015:504208. doi: 10.1155/2015/504208. Epub 2015 Jul 26.'}, {'pmid': '19838199', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Ankylosing Spondylitis (AS) is a chronic rheumatic disease that principally affects the intervertebral and sacroiliac joints. Two major features of AS are inflammation and bone reformation. Th17 cells as a new subpopulation of CD4+ T cells, are characterized by the production of pro-inflammatory cytokines. Th17 cells have been implicated in autoimmune diseases, pathogenesis and diagnosis of several inflammatory diseases, such as AS. Regulatory T cells (Treg) with suppressive effects on inflammation and autoimmunity have been reported to implicate in pathology of AS. The Treg /Th17 functional balance is essential for the prevention of autoimmune and inflammatory diseases by preventing deleterious impairment to the host and mounting effective immune responses. A group of circulating miRNA in plasma is found to be the change they can be involved in inflammation or inhibit it. miRNAs have been shown to play a pivotal role in the pathogenesis of various diseases including autoimmune or auto-inflammatory diseases.The function and molecular pathways of several key deregulated miRNAs, are elucidated in AS patients. Curcumin is an active component of turmeric which is a perennial plant. Curcumin is able to exert anti-atherogenic, anti-cancer and anti-inflammatory effects. The curcumin induces down-regulation of various inflammatory cytokines including TNF-α and IL-1. The solubility of curcumin in nanomicelles spherical water increases to more than 100 thousand times, which significantly enhances the absorption of curcumin. The aim of the present study was to understand the nano-curcumin effects on 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 AS and their correlation with the disease progression.', 'detailedDescription': 'A16-weeks randomized placebo-controlled study was conducted on a total of 24 patients with age range of 22 to 50, who were clinically diagnosed with ankylosing spondylitis on the basis of clinical manifestations. The AS patients were divided into 2 subgroup with a block randomization, 12 out of 24 received a daily dose of 80 mg oral nano-curcumin and 12 patients received placebo as control group in a period of 4 months. Peripheral blood samples (8 ml) were obtained from the patients in both control and treatment groups before and after nano-curcumin treatment for 4 months. PBMCs were isolated from samples using Ficoll separation technique. Subsequently, cells were cultured in the presence of PMA. Treg cells associated immunological parameters such as mRNA expression levels of mir-146a, mir-27 and mir-17, TGF-β, IL-10, IL-6 and FoxP3 and alsoTh17 related immunological parameters such as mRNA expression of mir-141, mir-155 and mir-200, IL-17, IL-23 and RORγt were measured by real-time PCR, also Treg and Th17 frequency and their related cytokines secretion levels were evaluated respectively by flowcytometry and ELISA technique in both groups, pre and post-treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '46 Years', 'minimumAge': '23 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willingness to cooperate\n* Aged 22 to 50 years\n* The diagnosis of ankylosing spondylitis by rheumatologist\n* Patients with a BASDAI \\> 4 as having active disease.\n* Disease duration 5-8 years\n\nExclusion Criteria:\n\n* Nutritional supplements and antioxidant alpha-lipoic acid a month before the study.\n* Pregnancy and lactation\n* History of diabetes and other chronic diseases\n* History of other autoimmune diseases\n* Occurrence of relapses during the study period\n* Acceptance rate of less than 70% of supplements\n* Unwillingness to continue to cooperate'}, 'identificationModule': {'nctId': 'NCT03140657', 'briefTitle': 'The Effects of Nanocurcumin on Treg Cells and Th17 Cells Responses in Ankylosing Spondylitis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tabriz University of Medical Sciences'}, 'officialTitle': 'The Effects of Oral Nanocurcumin on Expression Levels of microRNAs and Treg Cells and Th17 Cells Development Factors in Ankylosing Spondylitis Patients', 'orgStudyIdInfo': {'id': 'TabrizUMS-Rheumatology-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nanocurcumin Arm', 'description': 'Nanocurcumin capsules (the formulation of curcumin nanoparticles, Exirnanosina). Subjects randomized to Nanocurcumin Arm will receive 80 mg/day for 4 months.', 'interventionNames': ['Drug: Nanocurcumin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects randomized to Placebo Arm will receive placebo in the form of capsules for 4 months.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Nanocurcumin', 'type': 'DRUG', 'description': 'Nanocurcumin capsules (the formulation of curcumin nanoparticles, Exirnanosina). Subjects randomized to Nanocurcumin Arm will receive 80 mg/day for 4 months', 'armGroupLabels': ['Nanocurcumin Arm']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subjects randomized to Placebo Arm will receive placebo in the form of capsules for 4 months', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0413', 'city': 'Tabriz', 'country': 'Iran', 'facility': 'Connective Tissue Diseases Research Center', 'geoPoint': {'lat': 38.08, 'lon': 46.2919}}], 'overallOfficials': [{'name': 'Mehdi Yousefi, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'SCARM institute'}, {'name': 'Mehrzad Hajaliloo Bonab, Rheumatology', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tabriz University of Medical Sciences, Tabriz, Iran'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tabriz University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Mehdi Yousefi', 'investigatorAffiliation': 'Tabriz University of Medical Sciences'}}}}