Protocol summary

Summary
This study will examine effects of aqueous extract of black barberry fruit on clinical signs, some inflammatory factors, glycemic profile, lipid profile, blood pressure and percent of body fat 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 aqueous 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: hs-CRP, TNF α, ESR, FBS, TC, TG, LDL, HDL clinical signs, blood pressure, body fat percent, BMI and waist circumference will be assessed too.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201409249472N7
Registration date: 2015-01-18, 1393/10/28
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-01-18, 1393/10/28
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
2015-03-20, 1393/12/29
Expected recruitment end date
2016-03-18, 1394/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of aqueous extract of black barberry fruit on clinical signs, some inflammatory factors, glycemic profile, lipid Profile, blood pressure, and percent of body fat in active rheumatoid arthritis patients
Public title
Effects of aqueous extract of black barberry fruit on active rheumatoid arthritis Patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: person with RA disease as American College of Rheumatology (ACR) criteria; age between 20-69 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
2015-01-05, 1393/10/15
Ethics committee reference number
25092-93/10/15

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
pain
Timepoint
First day and three months later
Method of measurement
visual analogue scales

2

Description
Morning stiffness
Timepoint
First day and three months later
Method of measurement
Examintion

3

Description
Number of inflammated joints
Timepoint
First day and three months later
Method of measurement
Examintion

4

Description
DAS28
Timepoint
First day and three months later
Method of measurement
Examintion

5

Description
hs-CRP
Timepoint
First day and three months later
Method of measurement
elisa

6

Description
TNF α
Timepoint
First day and three months later
Method of measurement
Elisa

7

Description
ESR
Timepoint
First day and three months later
Method of measurement
Westergren

8

Description
FBS
Timepoint
First day and three months later
Method of measurement
GOD/POD

9

Description
TC
Timepoint
First day and three months later
Method of measurement
Enzymatic

10

Description
TG
Timepoint
First day and three months later
Method of measurement
Enzymatic

11

Description
LDL
Timepoint
First day and three months later
Method of measurement
Formula

12

Description
HDL
Timepoint
First day and three months later
Method of measurement
Enzymatic

13

Description
Systolic and diastolic blood pressure
Timepoint
First day and three months later
Method of measurement
Mercuyi barometer

14

Description
Body fat percent
Timepoint
First day and three months later
Method of measurement
BIA

Secondary outcomes

1

Description
Body mass index
Timepoint
First day and three months later
Method of measurement
Calculation

Intervention groups

1

Description
Taking aqueous 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
+98 21 8862 2707
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
+98 21 8862 2707
Email
n-aryaeian@sina.tums.ac.ir
Web page address

Person responsible for updating data

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
+98 21 8862 2707
Email
n-aryaeian@sina.tums.ac.ir
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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