Protocol summary
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Study aim
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To evaluate the effects of oral nanocurcumin, in levels of micro-RNAs expression and Treg and Th17 cell development factors in patients with multiple sclerosis
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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 = 25) receiving placebo capsules and treated group (n = 25) receiving nanocurcumin capsules
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Settings and conduct
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In this study, patients with multiple sclerosis 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:
Ranging in age from 28 to 51 years
MS diagnosis by neurologist
patients in relapse and remitting
EDSS<5/5
Exclusion criteria:
History of diabetes and other chronic diseases;
History of other autoimmune disease;
corticosteroid use during illness;
the occurrence of relapses during the study phase
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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 6 months.
Control group: Placebo The control capsule took on a daily basis over a period of 6 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, miRNA 106, miRNA25, the frequency of Treg calls and Th17 cells, the expression of the RoRγt، Foxp3, the expression of the IL-23 and IL-17, IL-10 ، TGF-b , and the secretion levels of these cytokines in patients with multiple sclerosis compared with the control group.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2016042227520N1
Registration date:
2016-05-29, 1395/03/09
Registration timing:
prospective
Last update:
2019-09-04, 1398/06/13
Update count:
1
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Registration date
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2016-05-29, 1395/03/09
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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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Drug Applied Research Center Tabriz University Of Medical Sciences
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Expected recruitment start date
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2016-06-04, 1395/03/15
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Expected recruitment end date
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2017-01-19, 1395/10/30
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Actual recruitment start date
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2016-06-08, 1395/03/19
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Actual recruitment end date
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2016-08-10, 1395/05/20
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Trial completion date
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2017-11-07, 1396/08/16
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Scientific title
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The effects of oral nanocurcumin on expression levels of microRNAs and Treg cells and Th17 cells development factors in Multiple Sclerosis patients
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Public title
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The effects of oral nanocurcumin in Multiple Sclerosis patients
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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 from 28 to 51 years
MS diagnosis by neurologist
patients in relapse and remitting
EDSS<5/5
Exclusion criteria:
Used nutritional supplements and antioxidants and alpha lipoic acid within a month before the study
Pregnancy and lactation;
History of diabetes and other chronic diseases;
History of other autoimmune disease;
corticosteroid use during illness;
the occurrence of relapses during the study phase;
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:
50
Actual sample size reached:
41
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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 25 participants in the intervention group, who receive nanocurcumin capsules and 25 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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ClinicalTrials.gov
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Secondary trial Id
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NCT03150966
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Registration date
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2017-05-12, 1396/02/22
Ethics committees
1
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Ethics committee
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Approval date
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2016-03-07, 1394/12/17
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Ethics committee reference number
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TBZMED.REC.1394.1177
Health conditions studied
1
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Description of health condition studied
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Multiple sclerosis
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ICD-10 code
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G35
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ICD-10 code description
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Multiple sclerosis
Primary outcomes
1
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Description
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miRNA-106b
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Timepoint
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Before interference and six months after interference
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Method of measurement
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Examined the expression levels of miRNA-106b by using Quantitative Real time PCR
2
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Description
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miRNA-25
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Timepoint
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Before interference and six months after interference
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Method of measurement
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Examined the expression levels of miRNA-25 by using Quantitative Real time PCR
3
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Description
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miRNA-326
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Timepoint
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Before interference and six 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
4
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Description
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The frequency of Treg cells
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Timepoint
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Before interference and six months after interference
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Method of measurement
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Examined the frequency of Treg cells by using flow cytometry
5
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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 six months after interference
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Method of measurement
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Examined the frequency of Th17 cells by using flow cytometry
6
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Description
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Transcription factor: Foxp3
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Timepoint
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Before interference and six months after interference
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Method of measurement
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Examined the expression levels of Foxp3 by using Quantitative Real time PCR
7
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Description
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Transcription factor: RoRγt
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Timepoint
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Before interference and six 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
8
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Description
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Cytokine: TGF-β
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Timepoint
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Before interference and six months after interference
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Method of measurement
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Examined the expression levels of TGF-β by using Quantitative Real time PCR
9
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Description
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Cytokine: IL-17
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Timepoint
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Before interference and six 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
10
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Description
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Cytokine: TGF-β
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Timepoint
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Before interference and six months after interference
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Method of measurement
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Examined the amount of secreted cytokine TGF-β by using sandwich ELISA method.
11
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Description
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Cytokine: IL-17
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Timepoint
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Before interference and six 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.
Intervention groups
1
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Description
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The control group received placebo capsules once a day for six months.
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Category
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Treatment - Drugs
2
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Description
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Supplementation group received nanocurcumin capsules containing 80 mg nanocurcumin once a day for six months .
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Category
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Treatment - Drugs
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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Drug Applied 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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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable