Protocol summary
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Study aim
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To evaluate the effects of oral nanocurcumin in levels of micro-RNA expression and Th17 cell development factors in patients with ankylosing spondylitis
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Design
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Clinical trials with control group, with parallel groups, randomized. Patients were randomly assigned into two groups of control (n = 12) receiving placebo capsules and treated group (n = 12) receiving nanocurcumin capsules
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Settings and conduct
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In this study, patients with ankylosing spondylitis is studied. These individuals are selected randomly from among referrals to neurologist at Tabriz University of Medical Sciences, based on laboratory findings and medical records content. The treatment group received 80 mg of nanocurcumin The control group also received placebo capsules.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria:
Willingness to cooperate; ranging in age 28 to 51 years; diagnosis of ankylosing spondylitis by rheumatologist; patients with a BASDAI > 4 as having active disease; disease duration 5-8 years.
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.
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Intervention groups
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Intervention group: nanocurcumin Patients in intervention group took nanocurcumin capsules on a daily basis over a period of 4 months. Control group: Placebo The control capsule took on a daily basis over a period of 4 months.
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Main outcome variables
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In this study, the effect of oral nanocurcumin were investigated on the expression of miRNA326, the frequency of Th17 cells, the expression of the RoRγt the expression of the IL-17, and the secretion levels of this cytokine in patients with ankylosing spondylitis compared with the control group.
General information
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Reason for update
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Acronym
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AS
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IRCT registration information
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IRCT registration number:
IRCT2017052927520N7
Registration date:
2017-06-13, 1396/03/23
Registration timing:
registered_while_recruiting
Last update:
2019-09-08, 1398/06/17
Update count:
1
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Registration date
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2017-06-13, 1396/03/23
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Tabriz University of Medical Sciences
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Expected recruitment start date
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2017-04-20, 1396/01/31
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Expected recruitment end date
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2017-12-29, 1396/10/08
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Actual recruitment start date
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2017-04-29, 1396/02/09
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Actual recruitment end date
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2017-11-07, 1396/08/16
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Trial completion date
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2018-01-18, 1396/10/28
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Scientific title
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The effects of oral nanocurcumin on expression levels of microRNA and Th17 cells development factors in ankylosing spondylitis patients
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Public title
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Oral nanocurcumin and treatment of ankylosing spondylitis
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Purpose
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Health service research
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Inclusion/Exclusion criteria
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Inclusion criteria:
Willingness to cooperate; ranging in age 28 to 51 years
diagnosis of ankylosing spondylitis by rheumatologist
patients with a BASDAI > 4 as having active disease
disease duration 5-8 years
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
acceptance rate of less than 70% of supplements
not wanting to continue cooperation.
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Age
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From 28 years old to 51 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
24
Actual sample size reached:
24
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block randomization
Blocking were used to balance the number of samples assigned to each study groups . The size of all blocks is equal and the blocks included 12 participants in the intervention group, who receive nanocurcumin capsules and 12 participants in the control group who receive placebo capsules.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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1. Participant
2. Outcome assessor
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Secondary Ids
1
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Registry name
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CT.gov
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Secondary trial Id
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NCT03140657
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Registration date
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2017-05-04, 1396/02/14
Ethics committees
1
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Ethics committee
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Approval date
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2016-08-29, 1395/06/08
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Ethics committee reference number
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IR.TBZMED.REC.1395.599
Health conditions studied
1
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Description of health condition studied
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Ankylosing Spondylitis
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ICD-10 code
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M45
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ICD-10 code description
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Ankylosing spondylitis
Primary outcomes
1
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Description
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miRNA-326
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Timepoint
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Before interference and four months after interference
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Method of measurement
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Examined the expression levels of miRNA-326 by using Quantitative Real time PCR
2
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Description
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The frequency of Th17 cells
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Timepoint
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Before interference and four months after interference
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Method of measurement
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Examined the frequency of Th17 cells by using flow cytometry
3
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Description
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Transcription factor: RoRγt
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Timepoint
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Before interference and four months after interference
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Method of measurement
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Examined the expression levels of RoRγt by using Quantitative Real time PCR
4
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Description
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Cytokine: IL-17
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Timepoint
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Before interference and four months after interference
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Method of measurement
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Examined the expression levels of IL-17 by using Quantitative Real time PCR
5
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Description
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Cytokine: IL-17
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Timepoint
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Before interference and four months after interference
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Method of measurement
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Examined the amount of secreted cytokine IL-17 by using sandwich ELISA method.
Secondary outcomes
1
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Description
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Cellular and molecular changes in the immune system
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Timepoint
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after 4 months
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Method of measurement
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Flow cytometry, ELISA, RT-PCR
Intervention groups
1
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Description
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Supplementation group received nanocurcumin capsules containing 80 mg nanocurcumin once a day for four months
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Category
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Treatment - Drugs
2
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Description
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The control group received placebo capsules once a day for four months.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Connective Tissue Diseases Research Center
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable