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 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 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.
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:2019-05-09, 1398/02/19
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 development factors and serum IL-17 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
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.