Protocol summary

Summary
Goals: The effects of cinnamon on clinical symptoms, fasting blood glucose, lipid profile, liver enzymes, blood pressure and some inflammatory biomarkers in women with rheumatoid arthritis referred to rheumatology clinic colleague, 40 female patients with rheumatoid arthritis after examination by a rheumatologist enrolled in the study And randomly will be divided into two groups: intervention and placebo. Inclusion criteria: Patient consent to participate in the study- Diagnosis of rheumatoid arthritis According to american college Rheumatology criteria (ACR) -Female gender-Age over 18 years-The disease duration for at least two years-Having active disease- Exclusion criteria:Rejection of cinnamon capsules-Developing sudden acute illness،Immigration،Any change in treatment protocol and drugs that led to the removal of the study, Intolerance or food allergy.interventions: the intervention group four capsules 500 mg Cinnamon and the other group will use placebo for 8 weeks. At the beginning and end of the study Clinical sign acorrding to the number of swollen joints,number of painful joints and indicators of disease activity score in 28 joints by using DAS-28 questionnaire, serum levels of fasting blood sugar , lipid profile(TC,TG,LDL.c,HDL.c), liver enzymes ALT,AST, inflammatory markers CRP, TNF- α, ESR and blood pressure will be measured and compared between the two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016020414680N3
Registration date: 2016-02-13, 1394/11/24
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-02-13, 1394/11/24
Registrant information
Name
Farideh Shishehbor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8430
Email address
shishehbor-f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technological Development, Ahvaz Jundishapoor University of Medical Sciences
Expected recruitment start date
2016-04-02, 1395/01/14
Expected recruitment end date
2016-04-08, 1395/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cinnamon on the clinical signs, fasting blood sugar , lipid profile , liver enzymes , blood pressure and inflammatory markers in women with rheumatoid arthritis
Public title
Effects of oral administration of cinnamon on rheumatoid arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosis of rheumatoid arthritis According to American College Rheumatology criteria (ACR) -Female gender-Age over 18 years-The disease duration for at least two years-Having active disease- Exclusion criteria:Rejection of cinnamon capsules(the receptionless than 80 %)-Developing sudden acute illness،Immigration،Any change in treatment protocol and drugs that led to the removal of the study.
Age
From 18 years old to 100 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of Ahvaz Jundishapur University of Medical Science
Street address
The Ethics Committee, Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences, University City, Golestan blvd.
City
Ahvaz
Postal code
Approval date
2016-01-23, 1394/11/03
Ethics committee reference number
IR.AJUMS.REC.1394.573

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
CRP
Timepoint
Before and after 8 weeks of intervention
Method of measurement
Latex method

2

Description
TNF-α
Timepoint
Before and after 8 weeks of intervention
Method of measurement
ELISA

3

Description
Systolic blood pressure
Timepoint
Before and after 8 weeks of intervention
Method of measurement
Barometer

4

Description
Diastolic blood pressure
Timepoint
Before and after 8 weeks of intervention
Method of measurement
Barometer

5

Description
triglyceride
Timepoint
Before and after 8 weeks of intervention
Method of measurement
Enzymatic Method

6

Description
Total cholesterol
Timepoint
Before and after 8 weeks of intervention
Method of measurement
Enzymatic Method

7

Description
HDL cholesterol
Timepoint
Before and after 8 weeks of intervention
Method of measurement
Enzymatic Method

8

Description
LDL cholesterol
Timepoint
Before and after 8 weeks of intervention
Method of measurement
Fried-Wald formula

9

Description
fasting blood sugar
Timepoint
Before and after 8 weeks of intervention
Method of measurement
Colorimetric method

10

Description
ALT
Timepoint
Before and after 8 weeks of intervention
Method of measurement
UV tes

11

Description
AST
Timepoint
Before and after 8 weeks of intervention
Method of measurement
UV test

12

Description
ESR
Timepoint
Before and after 8 weeks of intervention
Method of measurement
Westergren

13

Description
disease activity score
Timepoint
Before and after 8 weeks of intervention
Method of measurement
DAS-28 questionnaire

Secondary outcomes

1

Description
Body mass index
Timepoint
Before and after 8 weeks of intervention
Method of measurement
Calculation

Intervention groups

1

Description
intervention group:Four cinnamon capsules 500 mg daily for 8 week
Category
Other

2

Description
The placebo group:Four placebo daily for 8 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
clinic of Physician rheumatologist colleague،Elham Rajaei
Full name of responsible person
Elham rajaei
Street address
Ahvaz,Kianpars st.
City
ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology,Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr.Nader Saki
Street address
Vice Chancellor for Research and Technology.Ahvaz Jundishapur University of Medical Sciences,University city,Golestan Blvd.
City
Ahvaz
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 and Technology,Ahvaz Jundishapur University of Medical Sciences
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
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Farideh Shishebor
Position
Nutrition PhD, Assistant professor, Ahvaz Jundishapour University of Medical Sciences
Other areas of specialty/work
Street address
Paramedics school, Ahvaz Jundishapour University of Medical Sciences , Golestan Blv., Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3373 8319
Fax
Email
shishehbor-f@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Farideh Shishebor
Position
Nutrition PhD, Assistant professor, Ahvaz Jundishapour University of Medical Sciences
Other areas of specialty/work
Street address
Paramedics school, Ahvaz Jundishapour University of Medical Sciences , Golestan Blv
City
ahvaz
Postal code
Phone
+98 61 3373 8319
Fax
Email
shishehbor-f@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Farideh Shishebor
Position
Nutrition PhD, Assistant professor, Ahvaz Jundishapour University of Medical Sciences
Other areas of specialty/work
Street address
Paramedics school, Ahvaz Jundishapour University of Medical Sciences , Golestan Blv., Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3373 8319
Fax
Email
shishehbor-f@ajums.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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