This study will examine effects of hydroalcoholic extract of black barberry fruit on some immunity mediators in patients with active RA referring to Shariaty Hospital. In a randomized, double blind, placebo controlled clinical trial, 80 patients, aged between 18-69 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 (40 numbers in each group) including: 1- Black barberry consumers (case) and 2-Placebo consumers (control) randomly. Patients in case group will receive 2000 mg of hydroalcoholic extract of black barberry daily (by two 1000 mg capsules) for 3 months and control patients will receive 2000 mg maltodextrin daily (by two 1000mg capsules) , one 1000 mg capsule before lunch and one before dinner respectively for 3 months. Placebo capsules are completely similar to the others and will be given randomly to Patients. Patients will be control by calling weekly and visiting monthly. for comparing two groups before and after the 3 months intervention period these tests will be operated on them: IL-2, IL-4, IL-10, IL-17 and BMI.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201510259472N8
Registration date:2016-04-03, 1395/01/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-03, 1395/01/15
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-chancellor for research, Iran University of Medical Science
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Hydroalcoholic Extract of Black Barberry Fruit on some immunity mediators in Active Rheumatoid Arthritis Patients
Public title
Effects of Hydroalcoholic Extract of Black Barberry Fruit in Active Rheumatoid Arthritis Patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: person with RA disease as American College of Rheumatology (ACR) criteria; age between 18-69 years; having RA from 1 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 strickening to an acute disease; migration ; any change in drug and treatment protocol that can cause omission from study.
Age
From 18 years old to 69 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
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
2016-03-09, 1394/12/19
Ethics committee reference number
IR.IUMS.REC.1394.27.85
Health conditions studied
1
Description of health condition studied
Active rheumatoid arthritis
ICD-10 code
M06.8
ICD-10 code description
Other specified rheumatoid arthritis
Primary outcomes
1
Description
IL2
Timepoint
First day and three months later
Method of measurement
Elisa
2
Description
IL4
Timepoint
First day and three months later
Method of measurement
Elisa
3
Description
IL10
Timepoint
First day and three months later
Method of measurement
Elisa
4
Description
IL17
Timepoint
First day and three months later
Method of measurement
Elisa
Secondary outcomes
1
Description
BMI
Timepoint
First day and three months later
Method of measurement
Calculation
Intervention groups
1
Description
Taking Hydroalcoholic extract of black barberry supplement, 2000 miligram (2* 1000 milligrams capsules aqueous extract of black barberry per day for 3 months (12 weeks)
Category
Other
2
Description
Taking placebo, 2000 miligram (2* 1000 milligrams capsules) maltodextrin per day for 3 months (12 weeks).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rheumatology research center
Full name of responsible person
Dr. Farhad Shahram
Street address
Shariaty hospital, Jalal Ale Ahmad street
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
Iran University of Medical Sciences, Hemmat highway, Tehran
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 8877 9118
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 8877 9118
Fax
Email
n-aryaeian@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
ran 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 8877 9118
Fax
Email
n-aryaeian@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)