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Effect of oral nanocurcumin on disease activity, expression levels of microRNA and Th17 cells and Treg cells development factors and serum IL-17, IL-10 level in Behcet patients

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History
# Registration date Revision Id
4 2021-10-02, 1400/07/10 201470
3 2021-08-04, 1400/05/13 193235
2 2019-07-01, 1398/04/10 98196
1 2019-05-09, 1398/02/19 89481
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  • Protocol summary

    Effect of oral nanocurcumin on disease activity, expression levels of microRNA and Th17 cells development factors and serum IL-17 level in Behcet patients
    Effect of oral nanocurcumin on disease activity, expression levels of microRNA and Th17 cells and Treg cells development factors and serum IL-17 level in Behcet patients
    تعیین اثرات نانوکورکومین خوراکی بر فعالیت بیماری، میزان بیان میکرو RNA و فاکتورهای موثر در تکامل سلولهای Th17 و سطح سرمی IL-17 در بیماران مبتلا به بهجت
    تعیین اثرات نانوکورکومین خوراکی بر فعالیت بیماری، میزان بیان میکرو RNA و فاکتورهای موثر در تکامل سلولهای Th17 , Treg و سطح سرمی IL-17 ، IL-10در بیماران مبتلا به بهجت
    In this study, the effect of oral nanocurcumin were investigated on the expression of miRNA326, miRNA 155, miRNA181, the frequency of Th17 cells, the expression of the RoRγt, the expression of the IL-23 and IL-17 , and the secretion levels of IL-23 cytokines and IL-17 in patients with Behcet disease compared with the control group.
    In this study, the effect of oral nanocurcumin were investigated on the expression of miRNA326, miRNA 155, miRNA181, 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 Behcet disease compared with the control group.
    در این مطالعه اثرات نانوکورکومین خوراکی بر میزان بیان miRNA326، miRNA 155، miRNA181 ، بر میزان فراوانی سلول های Th17 ، میزان بیان فاکتور نسخه برداری RoRγt ، میزان بیان ژن سایتوکاین های IL-23 و IL-17 ، میزان ترشح سایتوکاین های IL-23 و IL-17 در بیماران مبتلا به بهجت در مقایسه با گروه کنترل بررسی خواهد شد.
    در این مطالعه اثرات نانوکورکومین خوراکی بر میزان بیان miRNA326، miRNA 155، miRNA181 ، بر میزان فراوانی سلول های Th17 , Treg ، میزان بیان فاکتور نسخه برداری RoRγt، Foxp3 ، میزان بیان ژن سایتوکاین های IL-23 و IL-17 ، IL-10 ، TGF-b، میزان ترشح سایتوکاین های مذکور در بیماران مبتلا به بهجت در مقایسه با گروه کنترل بررسی خواهد شد.

  • General information

    Effect of oral nanocurcumin on disease activity, expression levels of microRNA and Th17 cells development factors and serum IL-17 level in Behcet patients
    Effect of oral nanocurcumin on disease activity, expression levels of microRNA and Th17 cells and Treg cells development factors and serum IL-17, IL-10 level in Behcet patients
    بررسی اثرات نانوکورکومین خوراکی بر فعالیت بیماری، میزان بیان میکرو RNA و فاکتورهای موثر در تکامل سلولهای Th17 و سطح سرمی IL-17 در بیماران مبتلا به بهجت
    بررسی اثرات نانوکورکومین خوراکی بر فعالیت بیماری، میزان بیان میکرو RNA و فاکتورهای موثر در تکامل سلولهای Th17 ، Tregو سطح سرمی IL-17 , IL-10 در بیماران مبتلا به بهجت

  • Primary outcomes

    #1
    empty
    Frequency of Treg cells
    empty
    میزان فراوانی سلول های Treg
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    4 months after receiving the supplement or placebo
    empty
    4 ماه بعد از دریافت مکمل یا دارونما
    empty
    Flow cytometry
    empty
    فلوسیتومتری
    #2
    empty
    The expression of the Foxp3
    empty
    میزان بیان فاکتور نسخه برداری Foxp3
    empty
    4 months after receiving the supplement or placebo
    empty
    4 ماه بعد از دریافت مکمل یا دارونما
    empty
    QRT-PCR
    empty
    ریل تایم PCR
    #3
    empty
    TGF-b and IL-10 cytokine gene expression
    empty
    میزان بیان ژن سایتوکاین TGF-b و IL-10
    empty
    4 months after receiving the supplement or placebo
    empty
    4 ماه بعد از دریافت مکمل یا دارونما
    empty
    QRT-PCR
    empty
    ریل تایم PCR
    #4
    empty
    The level of TGF-b and IL-10 cytokine secretion
    empty
    میزان ترشح سایتوکاین TGF-b و IL-10
    empty
    4 months after receiving the supplement or placebo
    empty
    4 ماه بعد از دریافت مکمل یا دارونما
    empty
    Elisa
    empty
    الایزا

Protocol summary

Study aim
Effect of oral nanocurcumin on disease activity, expression levels of microRNA and Th17 cells and Treg cells development factors and serum IL-17 level in Behcet patients
Design
Clinical trials with control group, with parallel groups, randomized. Patients were randomly assigned into two groups of control (n = 14) receiving placebo capsules and treated group (n = 14) receiving nanocurcumin capsules
Settings and conduct
In this study, the patients with Behcet's syndrome is studied. These individuals are selected randomly from among referrals to rheumatologist at Tabriz University of Medical Sciences, based on laboratory findings and medical records content. The treatment group will receive 80 mg of nanocurcumin The control group will also receive placebo capsules.
Participants/Inclusion and exclusion criteria
Inclusion criteria: •Age range 20 to 60 years • Diagnosis of Behcet's disease by rheumatologist •Selection of patients will be based on the IBCD (The International Criteria for Behcet's Disease), which suggests that vascular, eye and joints threatening conflicts indicate the severity of the disease. ٍExclusion criteria: • History of diabetes and other chronic diseases • The history of other autoimmune diseases • Use of corticosteroids during illness
Intervention groups
The treatment group will receive 80 mg of nanocurcumin The control group will also receive placebo capsules.
Main outcome variables
In this study, the effect of oral nanocurcumin were investigated on the expression of miRNA326, miRNA 155, miRNA181, 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 Behcet disease compared with the control group.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160422027520N12
Registration date: 2019-05-09, 1398/02/19
Registration timing: prospective

Last update: 2019-07-27, 1398/05/05
Update count: 3
Registration date
2019-05-09, 1398/02/19
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
Expected recruitment start date
2019-06-10, 1398/03/20
Expected recruitment end date
2019-10-12, 1398/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral nanocurcumin on disease activity, expression levels of microRNA and Th17 cells and Treg cells development factors and serum IL-17, IL-10 level in Behcet patients
Public title
Effect of oral nanocurcumin in patients with Behcet's disease.
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to cooperate Age range 20 to 60 years Diagnosis of Behcet's disease by rheumatologist
Exclusion criteria:
Use of nutritional supplements and antioxidant and alpha-lipoic acid during a month before the study Pregnancy and lactation History of diabetes and other chronic diseases The history of other autoimmune diseases Use of corticosteroids during illness Admission rate less than 70% of supplemental intake
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 28
Randomization (investigator's opinion)
Randomized
Randomization description
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 14 participants in the intervention group, who receive nanocurcumin capsules and 14 participants in the control group who receive placebo capsules.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
-

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
GOLGASHT, University Avenue,Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2019-04-08, 1398/01/19
Ethics committee reference number
IR.TBZMED.REC.1398.037

Health conditions studied

1

Description of health condition studied
Behcet's disease
ICD-10 code
M35.2
ICD-10 code description
Behcet's disease

Primary outcomes

1

Description
The expression of miRNAs
Timepoint
4 months after receiving the supplement or placebo
Method of measurement
QRT-PCR

2

Description
Frequency of Th17 cells
Timepoint
4 months after receiving the supplement or placebo
Method of measurement
Flow cytometry

3

Description
The expression of the RoRγ
Timepoint
4 months after receiving the supplement or placebo
Method of measurement
QRT-PCR

4

Description
IL-23 and IL-17 cytokine gene expression
Timepoint
4 months after receiving the supplement or placebo
Method of measurement
QRT-PCR

5

Description
The level of IL-23 and IL-17 cytokine secretion
Timepoint
4 months after receiving the supplement or placebo
Method of measurement
Elisa

6

Description
Frequency of Treg cells
Timepoint
4 months after receiving the supplement or placebo
Method of measurement
Flow cytometry

7

Description
The expression of the Foxp3
Timepoint
4 months after receiving the supplement or placebo
Method of measurement
QRT-PCR

8

Description
TGF-b and IL-10 cytokine gene expression
Timepoint
4 months after receiving the supplement or placebo
Method of measurement
QRT-PCR

9

Description
The level of TGF-b and IL-10 cytokine secretion
Timepoint
4 months after receiving the supplement or placebo
Method of measurement
Elisa

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: nanocurcumin Patients in intervention group will take nanocurcumin capsules on a daily basis over a period of 4 months.
Category
Treatment - Drugs

2

Description
Control group: Placebo The control capsule will be taken on a daily basis over a period of 4 months.
Category
Placebo

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
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7582
Email
yousefime@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Connective Tissue Diseases Research Center
Full name of responsible person
Dr. Alireza Khabbazi
Street address
4rd floor, Connective Tissue Diseases Research Center,Imam Reza Hospital, Golgasht St, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 7582
Email
dr_khabbazi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Connective Tissue Diseases Research Center
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
Full name of responsible person
Mehdi Yousefi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Tabriz University of Medical Sciences, Golgasht Avenue,Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3336 4665
Fax
+98 41 3336 4665
Email
yousefime@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
Full name of responsible person
Mehdi Yousefi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Tabriz University of Medical Sciences, Golgasht Avenue,Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3336 4665
Fax
+98 41 3336 4665
Email
yousefime@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
Full name of responsible person
Mehdi Yousefi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Tabriz University of Medical Sciences, Golgasht Avenue,Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3336 4665
Fax
+98 41 3336 4665
Email
yousefime@tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
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