This study will examine the effect of Saffron supplement on the expression of some mediator genes of immunity and inflammation in patients with active rheumatoid arthritis referring to shariati Hospital. In a randomized, double blind (both patients and investigator), placebo controlled clinical trial, 66 patients, aged over 18 years old with active RA after rheumatologist examination and filling personal, medical and food questionnaires will be enrolled in the study. They will be divided in 2 groups (33 numbers in each group) including: 1- saffron powder consumers (case) and 2-Placebo consumers (control) randomly. Random assignment will be done by use of computer-generated random numbers.Patients in case group will receive Saffron pill containing 100 mg Saffron powder once a day for 3 months and control patients will receive Placebo pill containing 100 mg " maltodextrin " once a day for 3 months. Placebo capsules are completely similar to the others and will be given randomly to Patients. Patients will be controlled by calling weekly and visiting monthly. for comparing two groups before after the 3 months intervention period clinical outcomes will be assessed and these tests will be operated on them: ROR-ꝩt, T-bet,GATA3,Foxp3,PPAR-ꝩ, NF-kB, IL-17 AND IL-4 in two groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201707309472N15
Registration date:2017-10-15, 1396/07/23
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-10-15, 1396/07/23
Registrant information
Name
Naheed Aryaeian
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4750
Email address
aryaeian.n@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice- chanceller for research, Iran University of Medical Sciences
Expected recruitment start date
2017-10-21, 1396/07/29
Expected recruitment end date
2018-10-21, 1397/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Saffron consumption on some mediator genes of immunity and inflammation in adult with active rheumatoid arthritis
Public title
The effect of Saffron supplement on active rheumatoid arthritis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : diagnosis of rheumatoid arthritis as American College of Rheumatology (ACR) criteria; patients with age over 18 years; having RA from 2 years ago; active rheumatoid arthritis; acceptance of patient; not having diabetes mellitus, hypertension, thyroid problem, renal failure and liver dysfunction; not smoking; not being pregnant or lactated; not receiving omega-3 or antioxidants supplements from 3 month ago; not getting contraceptive drugs;
Exclusion criteria: reluctance for continuing the cooperation ; taking less than 80% of supplements given to patients at baseline (the compliance lower than %80); sudden onset of an acute disease; migration ; any change in drug and treatment protocol that can cause omission from study.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Blinding: Patients will be unaware of the type of intervention. investigator will not be aware of the intervention. Therefore, the trial will be run as double blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee in research of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, next to Milad tower, between Sheikh Fazlollah Noori and Chamran highway, Hemmat highway, Tehran, Iran
City
tehran
Postal code
Approval date
2017-07-12, 1396/04/21
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9411323004
Health conditions studied
1
Description of health condition studied
Active rheumathoid arthritis
ICD-10 code
M06.8
ICD-10 code description
Other specified rheumatoid arthritis
Primary outcomes
1
Description
ROR-ꝩt gene expression amount
Timepoint
before intervention AND 3 months after intervention
Method of measurement
real time PCR method in ΔΔCT
2
Description
PPAR-ꝩ gene expression amount
Timepoint
before intervention AND 3 months after intervention
Method of measurement
real time PCR method in ΔΔCT
3
Description
FoxP3 gene expression amount
Timepoint
before intervention AND 3 months after intervention
Method of measurement
real time PCR method in ΔΔCT
4
Description
GATA3 gene expression amount
Timepoint
before intervention AND 3 months after intervention
Method of measurement
real time PCR method in ΔΔCT
5
Description
NF-kB gene expression amount
Timepoint
before intervention AND 3 months after intervention
Method of measurement
real time PCR method in ΔΔCT
6
Description
t-bet gene expression amount
Timepoint
before intervention AND 3 months after intervention
Method of measurement
real time PCR method in ΔΔCT
7
Description
Interleukin-17
Timepoint
before intervention AND 3 months after intervention
Method of measurement
ELISA kit in pg/ml
8
Description
Interleukin-4
Timepoint
before intervention AND 3 months after intervention
Method of measurement
ELISA kit in pg/ml
Secondary outcomes
1
Description
BMI
Timepoint
before intervention AND 3 months after intervention
Method of measurement
formula
Intervention groups
1
Description
Control groups: Patients that refer to hospital shariati who wish to cooperate and have inclusion criteria will receive 100 mg maltodextrin (100 mg tablet) for 3 months
Category
Placebo
2
Description
Intervention Group: Patients that refer to hospital shariatti who wish to cooperate and have inclusion criteria will receive 100mg of powdered saffron daily (by one 100 mg tablet) for 3 months.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rheumatology research center of shariati hospital
Full name of responsible person
mehdi mahmoodi
Street address
south-karegar,jalal aleahmad st.shariati hospital
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice-chancellor for research, Iran University of Medical Science
Full name of responsible person
Dr Ali Javadmoosavi
Street address
hemmat highway,sheikh fazlolahe noori avenue.Iran univesiy of medical sciences
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice-chancellor for research, Iran University of Medical Science
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
Iran University of Medical Sciences
Full name of responsible person
Dr Naheed Aryaeian
Position
PhD in nutrition
Other areas of specialty/work
Street address
School of health, Iran University of Medical Sciences, Hemmat highway
City
Tehran
Postal code
Phone
+98 21 8670 4750
Fax
Email
n-aryaeian@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Naheed Aryaeian
Position
PhD in nutrition
Other areas of specialty/work
Street address
School of health, Iran University of Medical Sciences, Hemmat highway
City
Tehran
Postal code
Phone
+98 21 8670 4750
Fax
Email
n-aryaeian@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran univesity of medical sciences
Full name of responsible person
Dr Naheed Aryaeian
Position
phD in nutrition
Other areas of specialty/work
Street address
School of health, Iran University of Medical Sciences, Hemmat highway
City
Tehran
Postal code
Phone
+98 21 8670 4750
Fax
Email
n-aryaeian@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)