History
# Registration date Revision Id
2 2019-09-05, 1398/06/14 102845
1 2017-06-13, 1396/03/23 22524
Changes made to previous revision
This is the first revision

Protocol summary

Summary
To evaluate the effects of oral nanocurcumin in levels of micro-RNA expression and Th17 cell development factors in patients with ankylosing spondylitis, patients with clinical symptoms and radiographic results of spine, who their disease diagnosed by rheumatologist be referred to the person in charge of research. Then the study and its objectives and complements that are used and possible complications will be explained to the patient. In this study, after receiving written the questionnaire and obtaining the necessary information and history will be recorded. Then 8 cc of fasting blood will be taken from each patient. Patients randomly block (block randomization) in the control group (n=12) and supplements (n=12) are placed. The supplement group, will receive 80 mg nanocurcumin and the control group will receive placebo. During the 4-month period of study patients will take 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
AS
IRCT registration information
IRCT registration number: IRCT2017052927520N7
Registration date: 2017-06-13, 1396/03/23
Registration timing: registered_while_recruiting

Last update:
Update count: 1
Registration date
2017-06-13, 1396/03/23
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
Tabriz University of Medical Sciences
Expected recruitment start date
2017-05-07, 1396/02/17
Expected recruitment end date
2017-07-08, 1396/04/17
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 microRNA and Th17 cells development factors in ankylosing spondylitis patients
Public title
Oral nanocurcumin and treatment of ankylosing spondylitis
Purpose
Health service research
Inclusion/Exclusion criteria
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; corticosteroid use during illness; acceptance rate of less than 70% of supplements; not wanting to continue cooperation.
Age
From 28 years old to 51 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
CT.gov
Secondary trial Id
NCT03140657
Registration date
2017-04-28, 1396/02/08

Ethics committees

1

Ethics committee
Name of ethics committee
Connective Tissue Diseases Research Center
Street address
4rd floor, Connective Tissue Diseases Research Center,Imam Reza Hospital, Golgasht St, Tabriz, Iran
City
TABRIZ
Postal code
Approval date
2016-08-29, 1395/06/08
Ethics committee reference number
IR.TBZMED.REC.1395.599

Health conditions studied

1

Description of health condition studied
Ankylosing Spondylitis
ICD-10 code
M45
ICD-10 code description
Ankylosing spondylitis

Primary outcomes

1

Description
miRNA-326
Timepoint
Before interference and four months after interference
Method of measurement
Examined the expression levels of miRNA-326 by using Quantitative Real time PCR

2

Description
The frequency of Th17 cells
Timepoint
Before interference and four months after interference
Method of measurement
Examined the frequency of Th17 cells by using flow cytometry

3

Description
Transcription factor: RoRγt
Timepoint
Before interference and four months after interference
Method of measurement
Examined the expression levels of RoRγt by using Quantitative Real time PCR

4

Description
Cytokine: IL-17
Timepoint
Before interference and four months after interference
Method of measurement
Examined the expression levels of IL-17 by using Quantitative Real time PCR

5

Description
Cytokine: IL-17
Timepoint
Before interference and four months after interference
Method of measurement
Examined the amount of secreted cytokine IL-17 by using sandwich ELISA method.

Secondary outcomes

1

Description
Cellular and molecular changes in the immune system
Timepoint
after 4 months
Method of measurement
Flow cytometry, ELISA, RT-PCR

Intervention groups

1

Description
Supplementation group received nanocurcumin capsules containing 80 mg nanocurcumin once a day for four months
Category
Treatment - Drugs

2

Description
The control group received placebo capsules once a day for four months.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital, Tabriz
Full name of responsible person
Sanam Dolati
Street address
Imam Reza Hospital, Golgasht Avenue, Tabriz Tabriz
City
Tabriz

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
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
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
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
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
Sanam Dolati
Position
Ph.D student of Immunology
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences , Golgasht Avenue, Tabriz
City
Tabriz
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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