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, patients with clinical symptoms and MRI results , who their disease is diagnosed by neurological specialist definitively be referred the person in charge of research. Subjects examined by a neurologist and then determine the EDSS and approved the inclusion criteria to take a placebo or supplements will be introduced to researcher. In this study, after receiving written consent from the patient, personal information and history will be recorded. After completing the questionnaire and obtaining the necessary information 8 cc of fasting blood will be taken from each patient .Patients randomly block (block randomization) in the control group (n = 25) and supplements (n = 25) are placed. The supplement, 80 mg will receive nanocurcumin and the control group will receive placebo. During the 6-month period of study patients will take the capsule daily. In the end of study, 8 cc of fasting blood will be taken from patients who received nanocurcumin and placebo and then will be completed questionnaires and obtaining the necessary information.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016042227520N1
Registration date:2016-05-29, 1395/03/09
Registration timing:prospective
Last update:
Update count:1
Registration date
2016-05-29, 1395/03/09
Registrant information
Name
Mehdi Yousefi
Name of organization / entity
Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 4665
Email address
yousefime@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Drug Applied Research Center Tabriz University Of Medical Sciences
Expected recruitment start date
2016-06-04, 1395/03/15
Expected recruitment end date
2017-01-19, 1395/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of oral nanocurcumin on expression levels of microRNAs and Treg cells and Th17 cells development factors in Multiple Sclerosis patients
Public title
The effects of oral nanocurcumin in Multiple Sclerosis patients
Purpose
Health service research
Inclusion/Exclusion criteria
The inclusion criteria for this project:
Willingness to cooperate; Ranging in age from 18 to 51 years; MS diagnosis by neurologist; patients in relapse and remitting; EDSS<5/5.
Exclusion criteria were:
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; the occurrence of relapses during the study phase; corticosteroid use during illness; acceptance rate of less than 70% of supplements; not wanting to continue cooperation.
Age
From 18 years old to 51 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences , Golgasht Avenue, Tabriz
City
Tabriz
Postal code
Approval date
2016-03-07, 1394/12/17
Ethics committee reference number
TBZMED.REC.1394.1177
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
miRNA-106b
Timepoint
Before interference and six months after interference
Method of measurement
Examined the expression levels of miRNA-106b by using Quantitative Real time PCR
2
Description
miRNA-25
Timepoint
Before interference and six months after interference
Method of measurement
Examined the expression levels of miRNA-25 by using Quantitative Real time PCR
3
Description
miRNA-326
Timepoint
Before interference and six months after interference
Method of measurement
Examined the expression levels of miRNA-326 by using Quantitative Real time PCR
4
Description
The frequency of Treg cells
Timepoint
Before interference and six months after interference
Method of measurement
Examined the frequency of Treg cells by using flow cytometry
5
Description
The frequency of Th17 cells
Timepoint
Before interference and six months after interference
Method of measurement
Examined the frequency of Th17 cells by using flow cytometry
6
Description
Transcription factor: Foxp3
Timepoint
Before interference and six months after interference
Method of measurement
Examined the expression levels of Foxp3 by using Quantitative Real time PCR
7
Description
Transcription factor: RoRγt
Timepoint
Before interference and six months after interference
Method of measurement
Examined the expression levels of RoRγt by using Quantitative Real time PCR
8
Description
Cytokine: TGF-β
Timepoint
Before interference and six months after interference
Method of measurement
Examined the expression levels of TGF-β by using Quantitative Real time PCR
9
Description
Cytokine: IL-17
Timepoint
Before interference and six months after interference
Method of measurement
Examined the expression levels of IL-17 by using Quantitative Real time PCR
10
Description
Cytokine: TGF-β
Timepoint
Before interference and six months after interference
Method of measurement
Examined the amount of secreted cytokine TGF-β by using sandwich ELISA method.
11
Description
Cytokine: IL-17
Timepoint
Before interference and six months after interference
Method of measurement
Examined the amount of secreted cytokine IL-17 by using sandwich ELISA method.
Secondary outcomes
empty
Intervention groups
1
Description
The control group received placebo capsules once a day for six months.
Category
Treatment - Drugs
2
Description
Supplementation group received nanocurcumin capsules containing 80 mg nanocurcumin once a day for six months .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, Tabriz
Full name of responsible person
Mehdi Yousefi, Ph.D Of Medical Immunology
Street address
Imam Reza Hospital, Golgasht Avenue, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Drug Applied Research Center
Full name of responsible person
Hossein Babaei
Street address
Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Drug Applied Research Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Yousefi
Position
Ph.D Of Medical Immunology / Assistant Professor
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3336 4665
Fax
Email
Yousefime@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Yousefi
Position
Ph.D Of Medical Immunology / Assistant Professor
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3336 4665
Fax
Email
Yousefime@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Yousefi
Position
Ph.D Of Medical Immunology / Assistant Professor
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3336 4665
Fax
Email
Yousefime@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)